POTENTIAL COMPLICATIONS OF INSULIN THERAPY

  By admin | November 3, 2011 - 12:48 pm | Type 1 diabetes Comments Off

Potential complications directly related to insulin itself which both the health-care provider and the patient should be aware of are hypoglycemia, weight gain, exacerbation of retinopathy, insulin allergy, and lipodystrophy, each of which will now be discussed.

Hypoglycemia

The normal physiologic response to hypoglycemia includes early suppression of insulin secretion, release of glucagon and catecholamines, and later release of cortisol and growth hormone. It is important to understand that persons with Type 1 diabetes mellitus have alterations in the physiologic suppression of insulin and release of glucagon expected in response to low blood glucose, which impairs ability to return blood glucose levels to normal. These pathophysiologic alterations are present in as few as 5 years after Type 1 diabetes mellitus develops. In addition, hypoglycemia itself impairs the autonomic nervous system activation that is expected when hypoglycemia occurs, further impairing the patient’s response. For a full discussion of the pathophysiology of insulin counterregulatory responses in Type 1 diabetes mellitus.

Hypoglycemia is the most serious complication of intensive insulin replacement regimens and often will be the factor that limits ability to achieve intensive targeted glucose control. In the Diabetes Control and Complications Trial, patients in the intensive treatment group had a threefold greater risk (62%) of severe hypoglycemia when compared to those in the conventional treatment group (19%) (p < 0.001). It is therefore important to make efforts to prevent hypoglycemia from occurring in adults with Type 1 diabetes mellitus.

Practically speaking, mild hypoglycemic reactions that the patient senses and can treat are not uncommonly associated with intensive insulin therapy. Severe hypoglycemia with neuroglycopenia can however lead to confusion, aggressive behavior, loss of consciousness, seizures, coma, and death. Severe reactions may also result in motor vehicle accidents and serious falls with traumatic injuries. Certain patients, particularly those adults with long-standing Type 1 diabetes mellitus and autonomic neuropathy, may not subjectively sense any symptoms of hypoglycemia even in the presence of dangerously low-glucose concentrations. The presence of recurrent severe hypoglycemia is an indication to liberalize blood glucose targets, i.e., raise both the lower and upper limits of the target blood glucose range in order to prevent such occurrences. Risk of insulin-induced hypoglycemia can be reduced if the patient is carefully educated about recognition of his/her individual warning signs of hypoglycemia and/or of their blunting or absence as applicable, and know how to treat hypoglycemic reactions appropriately. If hypoglycemic unawareness is present, a family member and/or work colleague or friend(s) should be instructed in recognition of the signs and symptoms of hypoglycemia and in use of a glucagon emergency kit. In patients with advanced end-stage microvascular or macrovascular diabetes complications in whom the benefit of intensive glucose control is less clear, one may also consider liberalization of blood glucose targets in order to avoid increased risk of hypoglycemia that is inherent in intensive insulin treatment

regimens. Despite the higher risk of severe hypoglycemia with intensive insulin therapy, in the Diabetes Control and Complications Trial serial neuropsychological testing showed no long-term changes in cognitive function.

In Type 1 diabetes mellitus patients treated with Exubera, the frequency of all hypoglycemic episodes was similar to those treated with subcutaneous regular insulin over 12 and 24 weeks of therapy (5.58% vs. 5.4%, respectively). However, the rate of severe hypoglycemia [defined as that requiring assistance by another, involving a neurological symptom (memory loss, confusion, irrational behavior, unusual difficulty walking, seizure, loss of consciousness) and associated with an SMBG < 50 mg/dL or in the absence of SMBG, that which was reversible with oral carbohydrate, subcutaneous glucagon or intravenous glucose] was twice as frequent with insulin Exubera [6.5 vs. 3.3; RR 2.00 (CI 1.28 to 3.12)], compared with subcutaneous regular.

Treatment for mild hypoglycemia consists of 15 to 30 g of a rapidly absorbed source of carbohydrate such as 4 ounces of juice or regular soft drink, 4 ounces of skim milk, a small tube of gel cake frosting, or commercially available glucose tablets or gels. A finger-stick blood glucose check and the ingestion of carbohydrate is repeated every 15 to 20 minutes until the blood glucose level has returned to normal. Rapid-acting carbohydrate should be followed by a snack or by a meal that was missed or is due in order to prevent hypoglycemic recurrence.

In addition to the availability of glucose tablets, hard candy, or other sources of a readily absorbable form of carbohydrate, it is recommended that all patients with Type 1 diabetes mellitus should have emergency glucagon kits available at home and at work, assuming that there are people who can be trained in their use. In the event of an unconscious hypoglycemic reaction, 0.5 to 1 mg of glucagon given intramuscularly rapidly raises the plasma glucose concentration to an acceptable range and avoids the difficulties and dangers associated with attempting to get a comatose, stuporous, or disoriented individual to ingest glucose by mouth. Again, once the patient has sufficiently recovered from the episode, a snack or meal should be eaten.

Weight Gain

Improvement in glucose control with a reduction in glycosuria is often associated with weight gain as loss of calories in the urine is reduced. Increased food intake to treat or prevent recurrent hypoglycemia can also contribute to weight gain. Insulin itself may stimulate appetite. Recent data from clinical trials for insulin detemir consistently show slightly less weight gain when compared to NPH (as discussed in the insulin section earlier in this chapter). Mechanism(s) underlying a potential for less weight gain with insulin detemir are unknown. Data from mouse models suggest that dysregulation of insulin action at the level of the insulin receptor and downstream signaling targets in the central nervous system are associated with obesity and diabetes. In the brain, intact insulin signaling via the IRS-PI 3-kinase pathway is essential for nutrient homeostasis and appetite regulation as pharmacological inhibition of insulin signaling, especially in the hypothalamus, leads to obesity-induced diabetes. Keeping in mind that clinical trials have shown that insulin detemir therapy is characterized by weight stability or even modest weight loss, it has been hypothesized that in addition to activating the insulin-signaling cascade in peripheral tissues detemir may also activate cerebral insulin signaling. It is known that albumin directly penetrates into the cerebrospinal fluid across choroids plexus epithelial cells. In this model, it is postulated that detemir’s cerebral action may be enhanced due to its attached fatty acid chain. The long-term clinical significance of this modest but reproducible weight advantage that has been seen in clinical trials with detemir remains to be determined.

Exacerbation of Retinopathy

Intensive therapy slows the rate of development and progression of mild to moderate retinopathy. In addition, in the Diabetes Control and Complications Trial it was found that retinopathy occasionally worsens in the first year after initiation of intensive therapy, which manifests as an increase in the number of soft exudates (due to retinal infarcts in the superficial layers). This is felt to represent the closure of small retinal blood vessels that were narrowed but previously patent. Correction of hyperglycemia lowers plasma volume, which places marginal vessels at-risk. Increased availability of insulin-like growth factor-1 (IGF-1) may also contribute.

Despite the early exacerbation of retinopathy seen in the Diabetes Control and Complications Trial, there was clear evidence of benefit from intensive therapy when patients with mild to moderate nonpro-liferative retinopathy were followed for 9 years. Specifically, the incidence of worsening retinopathy in intensively treated patients was higher than in those receiving conventional therapy at 1 year (7.4% vs. 3%) but much lower at 9 years (25% vs. 53%).

Insulin Allergy

Allergy to recombinant human (rDNA) and biosynthetic insulin preparations is a rare complication of insulin therapy. Insulin antibodies of high titers were observed in many patients treated with early insulin preparations containing proinsulin, C-peptide, and other peptide contaminants. Immunoglobulin G-insulin antibodies in very high titers can lead to immune-mediated insulin resistance, which is now extremely rare.

Currently, the prevalence of allergic reactions during insulin treatment is around 2%, but less than one-third of reported events are considered related to insulin itself.

Transition from animal insulins to rDNA insulins has markedly decreased the incidence of allergic reactions. Allergenicity of the insulin molecule itself is felt to be attributed to the chemical structure of the terminal part of the beta chain. Other causes of insulin therapy associated allergic responses are other components of insulin preparations, including protamine, additives such as cresol or zinc, and latex.

Insulin antibodies of the immunoglobulin G and immunoglobulin E type are reported in low titers in patients treated exclusively with human insulin. Frequency and levels of immunoglobulin G-insulin antibodies are identical in patients treated either with biosynthetic or semisynthetic human insulin preparations. Allergic symptoms to human insulin are now found in less than 1% of de novo-treated patients. Overall immunological complications of insulin therapy have decreased significantly during the last two decades and are now predominantly observed in patients with interrupted insulin therapy.

The most common manifestation of allergic reactions to insulin consists of local wheal-and-flare reactions at the site of injection. Occasionally, more generalized allergic reactions occur, and even more rarely anaphylactic reactions. Mild local allergic reactions to insulin can be treated by first trying a switch to an alternative insulin preparation, or with antihistamines or by the addition of low doses of dexamethasone to the insulin vial. More severe reactions require desensitization. In the future, anti-immunoglobulin E treatment with omalizumab may offer another alternative to these patients.

Lipodystrophy: Lipoatrophy and Lipohypertrophy

Repeated insulin injections at a site sometimes lead to dystrophic change. Atrophy of subcutaneous fatty tissue known as lipoatrophy. Lipoatrophy is an immune complication of insulin therapy, which is not often seen seen since the development of the current human insulin preparations and insulin analogs. It was reported previously in 10% to 55% of patients treated with nonpurified bovine/porcine insulin preparations, but has almost disappeared since the advent of human insulins. In fact, injection of these newer preparations directly into the atrophic area often resulted in restoration of normal contours. Even with the purified human insulins, hypertrophy of subcutaneous fatty tissue may be a problem if one injects repeatedly at the same site. This complication of insulin therapy may be largely avoided by broad rotation of subcutaneous shot or CSII pump insertions sites. Lipohypertrophy that is problematic may be treated by liposuction.

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PHYSIOLOGIC REPLACEMENT THERAPY INSULIN REGIMENS

  By admin | November 3, 2011 - 12:47 pm | Type 1 diabetes Comments Off

Conventional Insulin Therapy

Conventional insulin therapy is used to describe simpler, usually fixed dose insulin regimens, such as single daily injections, or two injections per day of regular and NPH insulin, either mixed together in the same syringe or provided as a premix of insulins, which are given in prespecified doses before breakfast and dinner. Such regimens are based on the concept that each of the insulin components in the two doses is covering insulin needs for one-quarter of the day and results in a single peak of insulin absorption. Such mixed-split regimens are not physiologic. In addition, conventional insulin therapy is unlikely to enable achievement of target HbAlc levels in patients with Type 1 diabetes mellitus and are no longer recommended unless the adult with Type 1 diabetes mellitus cannot or will not comply with an intensive insulin regimen.

Intensive Insulin Therapy

In patients with Type 1 diabetes mellitus and deficiency of endogenous insulin production, the exogenous insulin regimen will be designed to simulate as closely as possible the multiphasic profile of insulin secretory responses to meals and snacks present in normal subjects in order to enable targeted glycemic control. The term intensive insulin therapy is used to describe more complex insulin administration regimens in which basal insulin therapy is combined with bolus doses of insulin given three or more times daily timed to correspond with ingestion of meals and/or snacks. When the intensive insulin therapy is delivered by subcutaneous injection, the regimen is known as a multiple daily injection (multiple daily insulin) regimen. Intensive insulin therapy is also delivered by continuous subcutaneous insulin infusion (CSII) using an external insulin pump. Currently in the United States, approximately 25% to 30% of persons with Type 1 diabetes mellitus are treated with insulin pumps.

In multiple daily insulin, basal insulin is delivered as once or twice daily long-acting or twice daily intermediate-acting insulin and in CSII basal insulin is delivered in continuous fashion. In both multiple daily insulin and CSII, bolus/meal insulin is delivered as discrete doses in conjunction with food intake, by shot in the multiple daily insulin regimen and by activation of a bolus for delivery by the insulin pump in CSII.

In one trial comparing CSII using insulin aspart versus multiple daily insulin with insulin aspart and glargine, CSII therapy resulted in lower glycemic exposure [40% lower for CSII than multiple daily insulin as measured by area under the curve (AUC) glucose > 80 mg/dL and AUC glucose > 140 mg/dL] without increased risk of hypoglycemia [CSII: 92% (73% for nocturnal hypoglycemia), multiple daily insulin: 94% (72% for nocturnal hypoglycemia)], as compared with multiple daily insulin (93).

Considerations in the Decision to Intensify Insulin Therapy

As mentioned earlier in this chapter, studies suggest that intensive therapy should be started as early as possible following the diagnosis of diabetes mellitus 1 and that it has clear benefits for patients with Type 1 diabetes mellitus when implemented at any time in the course of the disease. It is important to consider the practical aspects of such a regimen in the discussion with the adult patient with Type 1 diabetes mellitus who is to intensify insulin therapy. Following are the issues for consideration:

•   A commitment by the patient to follow the regimen is required. It will be necessary to manage and coordinate diet, activity, insulin administration, and blood glucose monitoring. Algorithms for insulin administration in multiple daily insulin management of Type 1 diabetes mellitus involve frequent monitoring of the blood glucose concentration, generally at a frequency of four or more times per day.

•   The incidence of hypoglycemia may be increased up to threefold in patients with Type 1 diabetes mellitus managed with intensive insulin regimens.

•   Weight gain is more likely with intensive insulin therapy regimens, which can limit patient compliance, particularly in women. Addition of pramlintide (Symlin) to the therapeutic regimen can help mitigate postprandial hyperglycemia and may allow weight loss rather than gain as hyperglycemia is controlled in some patients. Its ability to increase satiety, slow gastric emptying, and suppress glucagon secretion can impact postprandial hyperglycemia when used in combination with insulin therapy.

•   The cost of intensive insulin therapy is about three times that of conventional treatment, based upon an analysis of the Diabetes Control and Complications Trial. On the other hand, intensive therapy is associated with a lower incidence of costly chronic complications. Formal economic analyses have demonstrated that intensive therapy is cost-effective for the treatment of diabetes.

Multiple daily insulin Insulin Regimen

Long-Acting Basal Insulin Once (or Twice) Daily with Rapid-Acting Bolus Insulin Before Each Meal

This multiple daily insulin basal-bolus insulin regimen simulates the pattern of insulin production, which occurs physiologically in the person without diabetes. Basal insulin action will most commonly be provided by insulin glargine or detemir. Insulin glargine will generally be given once daily for control of fasting and premeal glucose levels. This dose is given at the same time daily and may be delivered either at bedtime, or with breakfast or dinner. It is a practical consideration to allow the patient to select which of these times of day he/she would be most likely to consistently take the basal insulin glargine dose to assure adherence to the regimen. In a small percentage of patients, the duration of action of glargine is not a full 24 hours, which then necessitates twice daily shots to provide continuous basal insulin action. Insulin detemir is given once or twice daily. Typically for the lean patient with Type 1 diabetes mellitus whose total daily insulin requirement is modest (and particularly if under 0.1 U/kg/day), twice daily dosing of insulin detemir is used. As discussed in the insulin section above, clinical trials dosing of detemir in Type 1 diabetes mellitus, which demonstrated safety and efficacy were carried out using both once and twice daily dosing of detemir. When dosed twice daily, insulin detemir is typically given with breakfast and at bedtime or at dinner time, depending upon which of the latter times would evenly distribute the timing of the twice daily doses. When used once daily, insulin detemir is typically dosed in the same fashion as described for insulin glargine, although it should be noted that currently in the United States, it is formally indicated only for PM dosing when prescribed once daily.

In the patient who is taking either insulin glargine or detemir as a once daily dose, a pattern whereby a rise in blood glucose levels in the hours prior to the time for administration of the basal insulin dose for the day, that is not attributable to the intake of food or reduction in the prior meal’s insulin dose, suggests that the basal insulin action is waning and that twice daily dosing is indicated.

Bolus doses of rapid-acting insulin analog are preferred in the multiple daily insulin regimen due to their rapid time to onset of action, which allows dosing with the meal, rather than regular insulin, which must be given with a 30 to 45 minute lag time if dosed premeal. The rapid-acting analogs will provide insulin coverage to control postmeal glycemic excursions. They may also be given if a carbohydrate containing snack is to be taken. As mentioned earlier and as discussed below under insulin adjustment recommendations for variations in meal portion size and carbohydrate content in detail, the meal bolus of insulin is generally matched to the carbohydrate content of the meal, either through implementation of a consistent carbohydrate diet or by using carbohydrate counting to match insulin dose to the meal’s carbohydrate content.

Alternative multiple daily insulin Regimens

Alternative multiple daily insulin regimens using NPH insulin have been described; however, they are generally not used widely for treating persons with diabetes mellitus 1 since the advent of the long-acting basal insulins, which when dosed once or twice daily have essentially no peak effect, thereby conferring lesser risk of hypoglycemia than an NPH-containing insulin regimen. In such regimens, three shots of NPH given at breakfast, dinner, and bedtime are used to meet the basal insulin requirement combined with two shots of rapid-acting bolus insulin delivered with breakfast and with dinner. The third dose of NPH insulin at bedtime in this multiple daily insulin regimen takes into account the observation that in individuals with Type 1 diabetes mellitus, the duration of action of the intermediate-acting insulin given before dinner is insufficient to control blood glucose in the early morning hours. Attempts to increase the dose of intermediate-acting insulin at dinner would expose the patient to a greater risk of hypoglycemia in the middle of the night, hence the incorporation of a modest dose of NPH at bedtime provides sufficient insulin action to control glycemia in the morning while minimizing risk of nocturnal hypoglycemia.

Practical Guidelines for Calculation of Insulin Doses for the multiple daily insulin Regimen

When undertaking calculation of insulin doses for initiation of therapy for any insulin regimen, one must be cognizant of the variability in total daily insulin requirements among individuals and within a given individual, and of the variation in a given insulin’s lag time to onset of action, time to peak, and duration of action. It is also necessary to be aware in the event of making a switch from one type of regimen to another of the level of blood glucose control prior to the time of change. In all of the practical guidelines presented in this chapter for insulin dosing, dosing suggestions are based on evidence presented in the literature and a conservative consensus of opinion designed to assure safety and avoid hypoglycemia at the time of introduction of the new insulin regimen. Close monitoring of finger-stick blood glucose values and insulin doses at the time of such transitions must be undertaken in order to monitor safety and effectiveness of the insulin regimen and to facilitate adjustments as needed to enable attainment of glycemic control targets.

Initiating Insulin Therapy in Type 1 diabetes mellitus

Most newly diagnosed patients with Type 1 diabetes mellitus can be started on a total daily dose (TDD) of 0.2 to 0.4 U of insulin/kg/day, although many may ultimately require 0.5 to 1.0 U/kg/day. In the event of newly diagnosed Type 1 diabetes mellitus with presentation in diabetic ketoacidosis, the total daily insulin requirement will be determined at the time of discontinuation of intravenous insulin infusion treatment. Approximately half (40-50%) of the calculated total daily insulin dose is given as basal either as once per day long-acting basal insulin (glargine or detemir) or as twice daily detemir insulin. The once daily long-acting basal insulin, as previously mentioned is generally given either at bedtime or in the morning; however, it may also be given at dinner time if this will be most convenient for the patient. The remainder of the TDD is then given as rapid-acting (preferred) or regular insulin, divided into before-meal bolus doses. The dose of bolus insulin to be taken before each meal is then allocated as 10% to 15% of the total daily insulin requirement with each meal and a smaller percentage, e.g., 3% to 5% with a snack. If there is a clear difference in the carbohydrate content or insulin requirement for given meals, then the distribution of prandial insulin may be tailored to accommodate the difference(s), e.g., if postbreakfast hyperglycemia is a challenge and lunch typically a smaller meal, one may choose to apportion 20% to 25% of the daily prandial insulin for breakfast, 10% to 15% for lunch, 15% to 20% for dinner, and 3% to 5% for the bedtime snack. Premeal dosages of bolus insulin can also be calculated based on the dietary intake (i.e., 1-2 units of insulin per 10-15 g of carbohydrate). These doses will subsequently be adjusted per usual meal size and content, as well as per how activity and exercise patterns impact individual BGs, as described in the insulin adjustment section below.

Converting from a Conventional Insulin Therapy Regimen to an multiple daily insulin Regimen

It is generally advisable to reduce the total daily basal insulin dose (units) when long-acting basal insulin is to be started at the time of conversion from twice daily NPH by 20% from the previous total daily basal NPH doses. This is particularly important if any episodes of hypoglycemia have been occurring and/or there has been a tendency for BGs to be at the lower limit of the patient’s target range on the prior intermediate insulin regimen in order to prevent hypoglycemia. If switching from twice daily doses of NPH insulin to once daily insulin glargine when the BGs have not been well-controlled, one may prescribe a glargine dose that is equivalent to the total number of units of NPH insulin that were being given daily.

If the patient switches from short-acting insulin (regular) to rapid-acting insulin (lispro, aspart, or glulisine), the dose of the rapid-acting insulin may need to be reduced and the dose of basal insulin may need to be increased, to compensate for the pharmacokinetic differences among these types of insulins, and in particular for the longer tail of regular insulin action that may provide some insulin effect between meals that the rapid-acting analog will not.

CSII by External Insulin Pump

An alternative method of delivering an intensive insulin therapy basal-bolus regimen is by CSII via an external pump. The insulin is delivered through a fine catheter from the pump to a subcutaneous insertion site. The pump delivers insulin as a preprogrammed, variable rate basal infusion as well as patient-directed boluses given before meals or snacks or in response to elevations in blood glucose concentration outside the prespecifled target range.

The basal insulin infusion rate for the adult patient with Type 1 diabetes mellitus commonly falls between 0.2 to 1 U/hr, although it can be higher. The basal rate can be programmed either to continue at a constant rate over the 24-hour period or more commonly to increase and decrease at predetermined times of the day to prevent anticipated excursions in the blood glucose concentration, for example, morning rises in glucose associated with the dawn phenomenon. Typically the patient with Type 1 diabetes mellitus will require anywhere from 3 to 4 or more alternative basal rates to enable tight glycemic control. Pumps provide the ability to use multiple alternative basal profiles to deal with recurrent patterns that require adjustment of insulin doses (e.g., menstruation, weekend lifestyle, and a variety of levels of exercise/activity). In addition they offer profiles, such as dual wave bolus or extended bolus to accommodate anticipated variations in eating patterns, e.g., for eating a large or extended multicourse meal.

Only rapid-acting or regular insulin is used in the insulin pump. Adjustments to the basal insulin infusion rate or changes in the size and timing of the insulin boluses generally allow more timely responses in blood glucose concentration than are seen when adjustments are made to doses of intermediate-acting or long-acting insulin. All of these features confer a potentially greater flexibility for the patient in terms of lifestyle and insulin dosing. It has been suggested that use of lispro insulin may lead to a lower risk of hypoglycemia than the other rapid insulin analogs and/or regular insulin in pumps.

Considerations in the Decision to Start CSII Pump Therapy

There are some practical considerations that the patient and provider must consider together when weighing a decision to use an insulin pump:

•   Patients treated with insulin pump therapy must always monitor glucose frequently (four or more times daily) and must always be alert to the possibility of failure of the infusion system, otherwise unexplained hyperglycemia develops.

•   The pump insertion set must be changed every 24 to 72 hours to assure uninterrupted insulin delivery and to prevent insertion site infections as described below.

•   There is a risk of infection at the subcutaneous insertion site. Infections may occur on average once annually per patient even when best of practices for insertion and site care are used. Such infections are usually minor and can be treated by changing the site of infusion and using a topical antibiotic; a short course of oral antibiotics may also sometimes be required. If an insertion site abscess develops, surgical drainage in conjunction with antibiotic treatment will be necessary.

•   Because rapid-acting insulin is most commonly used, pump failure as a result of mechanical malfunction or catheter-related problems can quickly result in severe hyperglycemia with ketoacidosis that will develop in a matter of hours, as mentioned earlier, in the patient with Type 1 diabetes mellitus.

•   The initial cost of an insulin pump itself is high ($4500-6000 in 2007). One must then also purchase pump supplies on an ongoing basis. The relatively recently released patch, OmniPod pump system requires a lesser initial payment for the PDA device that controls Pod functions and programs insulin dosing (~ $600). Single 72-hour use Pod units are then purchased in prospective fashion on a monthly basis for about $35 each, spreading out cost. Most health-insurance payors will cover 80% to 100% of the cost of a CSII pump system and supplies.

•   Some patients consider pump to be uncomfortable, embarrassing, or otherwise awkward.

Calculation of Initial Insulin Doses for CSII Pump Therapy

Basal will typically be delivered to meet between 40% and 50% of the patient’s total daily insulin requirement. The balance of the daily requirement is given as premeal bolus doses, which will control postprandial glucose excursions. In a patient with reasonably controlled previous multiple daily insulin injection regimen (e.g., Ale < 7.0%), the initial total daily dose of insulin (TDDI) administered by pump may be 10% to 20% less than the TDD of the previous regimen, as absorption of insulin from the subcutaneous delivery site is more efficient. Conversely, patients with a prior trend to hyperglycemia may start with the same TDD as they had been using with their subcutaneous injection regimen. In general, as in the multiple daily insulin regimens described earlier, approximately one-half of the total daily insulin dose is administered as basal insulin apportioned equally at the time of start up into an hourly delivery rate by dividing the desired total daily basal insulin dose by 24 hours to determine the number of units of insulin to be delivered per hour. For most patients, basal rates are in the range of 0.01 to 0.015 U/kg/hr (i.e., for a 60-kg woman approximately 0.6 to 0.9 U/hr), but they can range from under 0.5 to more than 2.0 U/hour. Premeal boluses for pump initiation may be estimated as follows: 20% for breakfast, 10% for lunch, 15% for dinner, and 5% for bedtime snack, or may be determined by carbohydrate counting and an individualized insulin-to-carbohydrate ratio.

The total daily basal rate can alternatively be calculated by multiplying the patient’s weight (in kg) by 0.3. Assuming that this basal rate represents 50% of the total daily insulin requirements for the person with Type 1 diabetes mellitus, an equivalent number of units of insulin used for basal delivery can be distributed between meal insulin boluses as described for multiple daily insulin above or again will alternatively be calculated using carbohydrate counting ratios.

Controlled clinical trials have indicated that on an average, intensive insulin regimens that use multiple insulin injections lead to levels of glucose control similar to those achieved with the insulin pump. On the other hand, there are some patients who never achieve adequate control with multiple daily injections but experience dramatic improvements with pump therapy. According to the Clinical Practice Recommendations of the American Diabetes Association, the insulin pump should be used only by candidates strongly motivated to improve glucose control and willing to work with their health-care provider in assuming substantial responsibility for their day-to-day diabetes self-management.

Implantable Insulin Infusion Pumps

A surgically implanted programmable pump is available in the European Union (EU) and is under investigation in the United States. Studies in patients with both Type 1 diabetes mellitus and type 2 diabetes mellitus have found that this pump system results in glycemic control equivalent to that of multiple daily insulin injections.

The implantable pump has the advantage, compared with intensive regimens using injections or external pumps, of a lower incidence of severe hypoglycemia (4 episodes/100 patient-years vs. 33 episodes/100 patient-years with multiple daily injections in patients with Type 1 diabetes mellitus) and less day-to-day fluctuation in blood glucose concentrations, less weight gain, and better quality of life. These advantages may occur, in part, because implantable pumps deliver into the peritoneal cavity or intravascularly, where absorption into the hepatic portal circulation provides more physiologic insulin delivery to the liver. Systemic insulin levels are lower than those that result when subcutaneous (subcutaneous) insulin shots are used.

Implantable pumps are prone to catheter blockage that may be due to either their slow rate of insulin delivery or increased macrophage activation in some patients. In addition, anti-insulin antibodies occur more commonly with continuous intraperitoneal insulin infusion (CPU) than with CSII.

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INSULIN DOSING ADJUSTMENTS AND PATTERN MANAGEMENT

  By admin | November 3, 2011 - 12:45 pm | Type 1 diabetes Comments Off

With experience and close observation of blood glucose results and insulin doses, the health-care provider and the patient can identify patterns that will suggest a need for adjustment in insulin doses to enable attainment of blood glucose targets and Ale goals in the adult Type 1 diabetes mellitus patient who is on an intensive insulin therapy regimen, whether it be with multiple daily insulin or CSII. Pattern management refers to the practice of reviewing a patient’s blood glucose logs, identifying patterns, and/or trends where blood glucose is outside or might be expected to deviate from designated target ranges, and taking corrective action to reach or maintain these ranges.

Numerous clinical circumstances can lead to changes in insulin requirements. These circumstances commonly involve: variations in food intake (portion size and carbohydrate content) and/or timing, exercise frequency, timing and level of intensity, days the patient is ill or stressed, changes in concomitant medications, (e.g., addition or withdrawal of glucocorticoids to/from the treatment regimen), and stage of the menstrual cycle. Even in the patient who adheres to the comprehensive diabetes management regimen, there will be times when blood glucose levels will shift, resulting in high and/or low blood glucose patterns. Finally, pregnancy will necessitate tight glycemic control and frequent adjustments in insulin doses to keep glucoses in target range. In all of these circumstances it will be appropriate for the health-care provider and the patient to evaluate the reasons that have led to suboptimal control in order to make adjustments in the subcutaneous insulin or lifestyle regimen to enable attainment and maintenance of target blood glucose levels. It is also extremely useful, when possible, to make anticipatory insulin adjustments when a recurring circumstance, e.g., exercise will occur in order to avoid loss of control moving forward.

Successful pattern management requires a close collaboration between the patient and the diabetes-care provider team. The Diabetes Control and Complications Trial and recent clinical trials in type 2 diabetes mellitus have demonstrated that, with appropriate education and the provision of insulin treatment algorithms, adult patients are able to self-titrate their insulin doses to achieve treatment targets identified by the patient and their care team.

The goals of pattern management are several fold. It will identify blood glucose trends that are outside target ranges by time of day; all variables that may have contributed to hyperglycemia or hypoglycemia; and provide strategies for safe and effective adjustments in insulin dose(s) that will return blood glucose to, or maintain blood glucose within desired ranges. For practical purposes, insulin adjustment guidelines may be broken into core and advanced adjustments. Basic insulin adjustment guidelines will target correction of low- and high-blood glucose levels, including those which occur on “sick” days, and incorporate core lifestyle considerations in order to (/) optimize the match between prandial insulin and carbohydrate intake to enable postprandial glycemic control and (//) necessary changes in insulin doses for routine exercise. Advanced insulin adjustment guidelines will address such circumstances as travel, perimenstrual patterns, glucocorticoid therapy, and dialysis days.

Establishing Individual blood glucose Goals and Times of Day for blood glucose Monitoring

When embarking on the process of pattern management, one must first establish glycemia-related targets and times of day that finger-stick blood glucose measurements will be performed for the individual patient. It is key to establish with the patient that the recommended goals are acceptable. Selecting mutually agreeable blood glucose goals will help to assure adherence to the prescribed regimen.

Individual targets must always be set for fasting and postprandial glucose and for HbAlc. It may be necessary to lay out stepwise goals for reaching targets over time, particularly if current levels of control are far removed from recommended values, or the patient has concerns regarding the recommended targets. Fear of hypoglycemia as a result of increase in insulin doses and “not feeling right/well” if blood glucose values are lowered to beyond a perceived threshold level are examples of reasons patients may cite as concerns regarding intensification of the insulin regimen that may necessitate stepping of goals and further education to enable them to become comfortable with increasing insulin doses.

Table Recommended Glycemia-Related Targets

Glycemic target ADA AACE
Fasting glucose 90-130 < 110
Postprandial glucose < 180 mg/dL <140
A1C < 7%; as close to 6% as possible < 6.5%
Glycemic variability Mean blood glucose should be < 2 SDs from the mean blood glucose

One additional concept that is increasingly recognized as a glycemia-related target is glycemic variability. This measure quantifies variation in blood glucose range over the time period of analysis. The concept of glycemic variability acknowledges the fact that HbAlc is an average of BGs in the 2 to 3 months preceding its measurement and that a normal value does not necessarily mean that all BGs have been within the prespecified target range. For example, if a patient has had numerous episodes of both hypoglycemia and hyperglycemia, the HbAlc may appear to be at target because it represents an average of all blood glucose values whether they be high, low, or within the target range. Glucose fluctuation, particularly during postprandial periods and during other times when blood glucose values swing, has been shown to exhibit a triggering effect on oxidative stress when compared to chronic sustained hyperglycemia. Free radical production in turn is implicated in the pathways that lead to hyperglycemic-induced vascular damage. Mean amplitude of glucose excursion (MAGE) correlates with free radical production and magnitude of glucose fluctuations.

Standard deviation from the average blood glucose may be used in clinical practice as a marker for MAGE. An initial goal for glycemic variability is suggested by Hirsch as twice the standard deviation (standard deviation) should be less than the average blood glucose level (standard deviation x 2 < average blood glucose). Even more desirable would be an average glucose level exceeding three times the standard deviation (standard deviation x 3 < average blood glucose). The standard deviation is calculated and reported by many of the currently available blood glucose monitor software programs.

All glycemia-related goals are also subject to modification in the presence of extenuating clinical circumstances such as blunted glycemic awareness, particularly if there is a history of hypoglycemia-related unconscious reactions or seizures, recurrent otherwise severe hypoglycemia, unstable cardiac status, end-stage renal disease, and the frail elderly warrant consideration of less tight glycemic control targets. For example, if a patient has unconscious hypoglycemic reactions, it may be quite appropriate to accept a target blood glucose range of 140 to 200 in order to minimize risk of recurrences.

FSBG measurements will in general be checked a minimum of four times daily in patients being managed with intensive insulin therapy regimens, and not uncommonly even more frequently. The times of day that it is desirable to see representative blood glucose values are those times that will enable meaningful adjustments in insulin doses or the lifestyle regimen. Typical times for checking are fasting and premeals to assess the appropriateness of basal insulin dosing, 60 to 90 minutes after a meal to assess the impact of premeal insulin doses, and 2 to 3 am in order to assess the level of glycemic control overnight as it affects one’s ability to move basal insulin doses up or down to optimize nocturnal blood glucose control. Patients should be encouraged to gather sample blood glucose readings from each of these time points when there is a question about the appropriateness of particular insulin doses and/or prior to office visits so that the health-care provider will have sufficient information to be able to assist in determining if the current insulin regimen is optimal. Those who will check less frequently should be advised to vary the times of day they are checking so that information from each of these times points is sampled.

In the initial stages of education, at a minimum, patients learning pattern management and self-titration of insulin doses should be encouraged to keep detailed records of blood glucose results, meal content, meal timing, activity, and exercise, etc. This will allow the diabetes team and the patient to learn the impact of these elements on glycemic control and insulin requirements. The patient should record comments in the blood glucose diary whenever BGs are above or below target at the time that the blood glucose value is noted, so that recall of circumstances that may have made the sugar high or low will be accurate. Insulin doses will then be adjusted, as is appropriate, based on identified relationships amongst blood glucose, food intake, and changes in activity.

Insulin Adjustment Guidelines

General Principles

Insulin adjustment is an art that should be guided by the science of what is known about how each component insulin of the total daily insulin requirement acts and how lifestyle and other variables impact blood glucose levels. Insulin adjustment guidelines are grounded in a sound knowledge of the pharmacokinetics of insulin, as discussed earlier in this chapter. When blood glucose levels are outside target ranges and it is determined that an adjustment in insulin dosing is necessary, knowledge of the action curves of the insulins that the patient is taking will guide the decision as to how to adjust the insulin regimen appropriately. The information presented in the following section is a composite of published information on this topic and a consensus of the accumulated clinical experience of the authors in caring for adult patients with Type 1 diabetes mellitus. We have attempted in presenting this information to provide a practical framework upon which the reader may build and convey to one’s patients the nuts and bolts of pattern management insulin adjustments.

For the patient with diabetes mellitus 1 on an multiple daily insulin regimen or using an insulin pump, the underlying principles for adjusting the insulin regimen are essentially the same. Fasting BGs that are not well-controlled will be corrected by adjusting the basal insulin dose(s), i.e., if the fasting blood glucose is low, the basal insulin dose will be decreased and if the fasting blood glucose is high, the basal insulin dose will be increased. Postmeal BGs that are not well-controlled will be corrected by adjusting the premeal insulin dose.

Table General Principles for Adjusting the Insulin Regimen

  Fasting blood glucose Postmeal blood glucose
blood glucose < target 4 Basal 4 Premeal bolus
blood glucose > target f Basal f Premeal bolus

If the postmeal blood glucose is low, then the bolus insulin dose given prior to the meal will be reduced; if the postmeal blood glucose is high, then the bolus insulin dose given prior to the meal will be increased. Insulin doses will be changed up or down by 10% to 20% or per a prespecifled dose adjustment formula or algorithm whenever required, based on the presence of hyperglycemia or hypoglycemia, respectively. In the outpatient setting, it is typical to wait several days in order to determine trends and/or patterns in BGs by time of day before making changes to the prescribed insulin regimen. This practice is known as pattern management.

Guidelines for Basal Insulin Adjustment

In the multiple daily insulin regimen when the basal insulin is once daily glargine or detemir, the dose will be adjusted based upon the fasting blood glucose. When the basal insulin is twice daily detemir or NPH the evening dose will be adjusted if the fasting blood glucose is not at target and if the predinner blood glucose is not at target, the morning NPH dose will be changed.

In CSII, basal insulin rates are adjusted empirically based on glucose monitoring results. Certain time periods during the day may require higher, while other periods may require lower infusion rates depending on individual factors including lifestyle and the dawn phenomenon. Two to four basal rates are routinely applied to meet insulin requirements over the course of a 24-hour period. For example, patients often need a lower basal rate between bedtime and 3 am and a higher basal rate between 3 am and the time they get up in the morning to attenuate the dawn phenomenon. An intermediate basal rate may be needed during the rest of the day. Adjustments to the basal rate(s) are usually made in 10% to 20% increments in order to affect clinically meaningful changes in blood glucose levels. Anticipatory changes in basal infusion rates should be made about 1 to 2 hours before a change in plasma blood glucose level is required, e.g., prior to exercise.

Guidelines for Prandial-Bolus Insulin Adjustment

Rapid-acting insulin analogs are preferred for use as the meal-time bolus insulin in the intensive insulin regimen for the person with Type 1 diabetes mellitus for several reasons. They may be given at the time that the meal will be eaten, rather than 30 to 45 minutes before the meal, as is necessary with regular insulin. The rapid-acting analogs may also be given at the end of or even up to 20 minutes after a meal, as discussed earlier in this chapter. This feature is particularly useful if the amount of food that will be eaten is uncertain. As the rapid-acting analogs peak 60 to 90 minutes after being taken, a finger-stick blood glucose is taken 60 to 90 minutes after the meal to assess the appropriateness of the bolus insulin dose that was delivered. The premeal insulin dose can then be adjusted to control postprandial glucose levels, i.e., if the postmeal blood glucose is above the patient’s postmeal blood glucose goal, or rises by more than 25 to 50 mg/dL from the premeal value, the meal bolus can be increased and conversely, if the postmeal blood glucose is lower than desired, the premeal bolus insulin dose will be reduced.

Practically speaking, for the patient who is either not able, for example due to time constraints, or not willing to check postprandial BGs, one may adjust the premeal insulin dose based on the blood glucose prior to the next meal, as has been done in some Exubera and Apidra trials with good results.

In the Type 1 diabetes mellitus patient who is being treated with conventional mixed, split subcutaneous insulin therapy rather than multiple daily insulin (e.g., two injections per day of mixed rapid-acting or regular and NPH insulin), adjustments in the prandial component of the prebreakfast dose are made based on the postbreakfast or prelunch blood glucose, changes in the intermediate-acting insulin component of the am dose will be based on the presupper blood glucose. To make adjustments in the presupper doses of insulin, the prandial component of the presupper insulin dose will be determined by the postsupper or bedtime blood glucose levels, whereas the NPH insulin component of the presupper dose is based on 3 am and/or fasting blood glucose levels.

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GUIDELINES FOR DOSING CORRECTION/SUPPLEMENTAL INSULIN

  By admin | November 3, 2011 - 12:44 pm | Type 1 diabetes Comments Off

Correction or supplemental doses of insulin are administered to correct hyperglycemia that results in spite of the patient having taken the usual prescribed basal and prandial insulin doses. Correction or supplemental doses of insulin is taken in addition to the usual basal and/or bolus insulin dose(s) to be administered at the time when the finger-stick blood glucose is checked and found to be high. The Correction or supplemental doses of insulin should not be large enough to cause, nor taken so frequently that overlapping peaks (insulin stacking) will result in hypoglycemia. Typically, approximately 1U of short-or rapid-acting insulin will lower blood glucose by 40 to 50 mg/dL in the patient with Type 1 diabetes mellitus. The blood glucose lowering response depends on the patient’s insulin sensitivity and daily insulin requirements varying from 0.5 to 3 U of short- or rapid-acting insulin for every 50 mg/dL lowering of blood glucose. If correction dose insulin is needed at bedtime, it should be administered at a reduced dose compared to other times of day in order to reduce risk of nocturnal hypoglycemia.

Several methods for determining Correction or supplemental doses of insulin are in use; however, studies to determine their specific safety and efficacy are lacking. Each method will take into account the patient’s relative sensitivity to insulin, either through an association with the known TDD of insulin being taken or the patient’s body weight. A key point to make regarding any method whereby Correction or supplemental doses of insulin of insulin are used is that the impact on blood glucose for an individual must be carefully monitored and the Correction or supplemental doses of insulin adjusted as necessary if it does not lower the blood glucose as expected or if it leads to hypoglycemia. This will require monitoring before and after the initial Correction or supplemental doses of insulin recommended is taken to allow determination of the most appropriate Correction or supplemental doses of insulin for the individual patient.

One method for determining starting correction insulin doses is to determine the dose as a simple percentage of the total number of units of insulin (basal plus bolus) that makes up the patient’s TDDI. Typically, the correction dose will be 10% of the TDDI. If marked hyperglycemia is present and/or urine ketones are positive, the correction dose will be 20% of the TDDI, rounded down to the nearest unit. For example, if the basal insulin dose is 14 U of glargine and the meal dose is 5 U of insulin aspart with breakfast, 3 U with lunch, and 4 U with dinner, the total daily dose of insulin is 26 U. A Correction or supplemental doses of insulin for moderate elevation in blood glucose would be 2 U of rapid-acting insulin and for more marked hyperglycemia, if urine ketones are present, would be 4 U of rapid-acting insulin. This correction dose will be taken in addition to a usual basal and/or bolus insulin dose to be taken whenever the finger-stick blood glucose is above a predesignated target value for that time of day.

A second method in widespread use was developed by Paul Davidson and applies an insulin correction factor. It is known as the rule of 1800 when a rapid-acting insulin analog is used and the rule of 1500 when regular insulin is used as the Correction or supplemental doses of insulin.

Table Sample Correction/Supplemental Dose Scale for Insulin Administration

  Correction dose scale for insulin”  
For blood glucose (mg/dL) Low dose Medium dosec High dose Personal dose scale
150-199 1 unit 1 unit 2 units units
200-249 2 units 3 units 4 units units
250-299 3 units 5 units 7 units units
300-349 4 units 7 units 10 units units
>349 5 units 8 units 12 units units

At bedtime and/or overnight, reduce the correction dose by half (50%), or take____units. (If this amount of insulin is less than one unit, do not take a dose.)

“For fingerstick glucose that is over 150 mg/dL or over______, take a correction insulin dose as shown on the selected scale in addition to your usual basal and meal insulin doses. Requires < 40 units insulin daily; or < 70 kg weight. Requires 40-99 units insulin daily; or 71-99 kg weight. Requires > 100 units insulin daily; or > 100 kg weight.

The correction factor calculated will provide an estimation of the number of mg/dL that 1 U of the correction insulin will lower the blood glucose. The Correction or supplemental doses of insulin will be the same insulin being used as prandial insulin for the patient. To calculate the correction factor for rapid-acting insulin analogs, 1800 is divided by the TDDI. For example, if a patient has a TDDI of 45 U, then the insulin correction factor would be: 1800 divided by 45 = 40. And 1 U of rapid-acting insulin would be expected to lower the blood glucose by 40 mg/dL. If the patient has a premeal blood sugar of 180 mg/dL and wants to correct to 100 mg/dL or cause the value to fall by 80 mg/dL, then the patient would take an extra 2 U of (80 mg/dL lowering divided by 40 mg/dL expected from 1 U correction dose) added to the number of units to be taken to cover the carbohydrates to be consumed in the meal.

Finally, a Correction or supplemental doses of insulin scale may be prescribed for the patient. Such scales will provide incremental, discrete stepped doses of insulin to be taken in response to progressively higher blood glucose levels, typically rising by 50 mg/dL/step on the scale. The correction dose scale differs from sliding scale insulin conceptually in two ways: (/) the selected dose of insulin will be given in addition to the prescribed basal plus prandial insulin doses to correct hyperglycemia and (//) the correction dose scale will factor in a surrogate measure of the patient’s known insulin sensitivity (i.e., TDDI or weight). Correction or supplemental doses of insulin scales are stratified as low, medium, or high dose with the option to provide an individualized scale.

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DIABETES EDUCATION, NUTRITION, EXERCISE, AND SPECIAL SITUATIONS

  By admin | November 3, 2011 - 12:35 pm | Type 1 diabetes Comments Off

EDUCATION

Diabetes education is required for all who are diagnosed with diabetes regardless of kind of diabetes or the age of the patient. Diabetes education does not ensure that patients will follow instructions and do everything that they are asked to do. Education is necessary but patients should be able to make the decision as to what they are willing to do to maintain or improve their health. Educators need to remember that just because someone decides that they will not follow directions for care, education was wasted. Everyone deserves to make an informed decision. Diabetes self-management training should be reimbursed as part of the care of the patient with diabetes since it is an enormous part of the treatment plan.

The scope of practice for diabetes educators defines the specialty and provides a framework for appropriate and effective practice of the specialty. This statement on the scope of practice for diabetes educators is not a static set of rules and definitions; rather, it is a fluid framework that adjusts to reflect the multidisciplinary nature of diabetes care, the evolving body of knowledge and evidence for effective interventions, and the ever-changing (and increasingly challenging) health-care environment.

DIABETES EDUCATOR’S SCOPE OF PRACTICE

All health-care providers need sufficient diabetes knowledge to provide safe, competent care to persons with or at risk for diabetes. As management of diabetes becomes increasingly complex, it is imperative that diabetes health-care professionals are well educated and appropriately credentialed. Expertise in diabetes care develops through experience, continuing education, individual study, and mentorship.

Diabetes educators use established principles of teaching and learning theory and lifestyle counseling to help clients confidently and effectively manage the disease. Instruction is individualized for persons of all ages, incorporating cultural preferences, health beliefs, and preferred learning styles of the client.

Behavior change directed at successful diabetes self-management was formally adopted as the desired outcome of Diabetes self-management training in 2002 (24). Seven specific self-care behaviors, known collectively as The American Association of Diabetes Educators 7 Self-Care Behaviors™, along with five core outcome measures, have been defined to guide the process of Diabetes self-management training.

The primary goal of diabetes education is to provide knowledge and skill training that helps individuals identify barriers and facilitates problem-solving and coping skills to achieve effective self-care behavior and behavior change. It is the position of the American Association of Diabetes Educators that all educators should measure the American Association of Diabetes Educators 7 Self-Care Behaviors, both for individuals and in the aggregate, at least twice: pre- and postintervention. The American Association of Diabetes Educators 7 Self-Care Behaviors are listed below:

1.  Healthy eating

2.  Being active

3.  Monitoring

4.  Taking medications

5.  Problem solving

6.  Healthy coping

7.  Reducing risks

Additional follow-up measurements are ideal and should be applied as appropriate to the practice setting. By adopting the American Association of Diabetes Educators 7 Self-Care Behaviors, educators are able to determine their effectiveness with individuals and populations, compare their performance with established benchmarks, and measure and quantify the unique contribution that Diabetes self-management training plays in the overall context of diabetes care.

American Association of Diabetes Educators

OUTCOMES MEASUREMENT STANDARDS

In the September/October issue of The Diabetes Educator American Association of Diabetes Educators published its position statement on standards for outcomes measurement of diabetes self-management education.

Seven diabetes self-care behavior measures determine the effectiveness of diabetes self-management education at individual, participant, and population levels. Diabetes self-care behaviors should be evaluated at baseline and then at regular intervals after the education program. The continuum of outcomes, including learning, behavioral, clinical, and health status, should be assessed to demonstrate the interrelationship between DSME and behavior change in the care of individuals with diabetes.

Individual patient outcomes are used to guide the intervention and improve care for that patient. Aggregate population outcomes are used to guide programmatic services and for continuous quality improvement activities for the DSME and the population it serves.

PRACTICE OPTIONS

Three practice options, which may overlap, are available to health-care professionals who choose to specialize in diabetes care:

1.  Diabetes educator

2.  Certified diabetes educator

3.  Board certified in advanced diabetes management

These classifications are differentiated by educational preparation, formal credentialing, professional practice regulations, and the clinical practice environment. It is the position of the American Association of Diabetes Educators that all diabetes educators work toward formal certification. The diabetes educator and Certified diabetes educator are chiefly concerned with and actively engaged in the process of Diabetes self-management training. The Board certified in advanced diabetes management incorporates skills and strategies of Diabetes self-management training into the more comprehensive clinical management of people with diabetes. Differences in the preparation, scope, and practice of diabetes educators (certified or not) and the Board certified in advanced diabetes management may make dual credentialing desirable for some. For example, a diabetes educator or Certified diabetes educator may also have the Board certified in advanced diabetes management credential, provided he or she meets the academic and practice requirements for Board certified in advanced diabetes management certification. Conversely, the Board certified in advanced diabetes management may not necessarily be a diabetes educator as defined here. A more comprehensive description of each classification is given below.

Diabetes educators are health-care professionals who have achieved a core body of knowledge and skills in the biological and social sciences, communication, counseling, and education and who have experience in the care of people with diabetes. Mastery of the knowledge and skills required to become a diabetes educator are obtained through formal and continuing education, individual study, and mentorship. The role of the diabetes educator can be assumed by professionals from a variety of health disciplines, including, but not limited to, registered nurses, registered dietitians, pharmacists, physicians, mental health professionals, podiatrists, optometrists, and exercise physiologists. The diabetes educator is an integral partner in the diabetes care team.

The diabetes educator understands the impact of acute or chronic problems on a person’s health behaviors and lifestyle, and on the teaching Aearning process. Such appreciation is essential for the development of a comprehensive plan for continuing education and cost-effective, self-care management.

Members of the various health disciplines who practice diabetes education bring their particular focus to the educational process. This widens or narrows the scope of practice for individual educators as is appropriate within the boundaries of each health profession, which may be regulated by national or state agencies or accrediting bodies. Regardless of discipline, the diabetes educator must be prepared to provide clients with the knowledge and skills to effectively manage his or her diabetes. Diabetes educators must possess a body of knowledge that spans across disciplines in order to provide comprehensive Diabetes self-management training. For example, dietitians who are diabetes educators provide instruction for insulin injection, insulin dosing, and medication side effects as well as providing nutrition counseling. Exercise physiologists in the diabetes educator role may help clients develop a meal plan, and pharmacists may provide counseling and instruction about foot care.

Diabetes educators may assume responsibilities beyond providing Diabetes self-management training to individuals. Program management; case management; clinical management; health-care consultancy with other providers, organizations, and industry; public and professional education; public health and wellness promotion; and research in diabetes management and education are all important roles assumed by diabetes educators.

CDEs, in addition to fulfilling the requirements of a diabetes educator, meet the academic, professional, and experiential requirements set forth by the National Certification Board for Diabetes Educators (NCBDE). The NCBDE defines the criteria for certification as a diabetes educator. As part of the application process, a diabetes educator must document that he or she meets all the criteria for certification. An accepted applicant must demonstrate competency in the required body of knowledge and skills by means of a written examination. Certification is valid for a period of 5 years, and is maintained either through repeat examination or through documented participation in relevant continuing education activities every 5 years.

Board certified in advanced diabetes management is a credential available since 2001. The Board certified in advanced diabetes management credential is the first advanced-practice certification offered to members of more than one discipline. Nurse Practitioners, Clinical Nurse Specialists, dietitians, and registered pharmacists may apply. Recognizing that nonnursing health-care professionals participate in diabetes care, the task force acknowledged the need for an advanced diabetes manager credential that includes nutrition and pharmacy as well as nursing.

Four discipline-specific examinations are offered for the Board certified in advanced diabetes management credential, reflecting the practice of comprehensive clinical management of individuals with diabetes. Candidates must document at least 500 hours of recent advanced-practice diabetes care. They must demonstrate skill in performing complete and/or focused assessments, recognizing and prioritizing complex data, and providing therapeutic problem-solving, counseling, and regimen adjustments for people with diabetes.

The educational preparation required to take the exams is as follows: a master’s degree in nursing is required for clinical nurse specialists and nurse practitioners, dietitians must have a relevant clinical master’s degree, and registered pharmacists must have a doctorate of pharmacy degree. Upon verification of eligibility, candidates sit for a discipline-specific written examination administered by the American Nurses Credentialing Center. Certification is valid for 5 years. Recertification is by reexamination or through qualified continuing education activities as defined by the American Nurses Credentialing Center. Additional information about certification and recertification can be obtained directly from the American Nurses Credentialing Center.

The Board certified in advanced diabetes management practice is characterized by autonomous assessment, problem identification, planning, implementation, and evaluation of diabetes care, within the guidelines for Board certified in advanced diabetes management practice set by the individual discipline. The process of using assessment data to independently derive a diagnosis or problem list is a key distinguishing aspect of Board certified in advanced diabetes management practice. A diabetes care professional with a Board certified in advanced diabetes management credential may or may not be a Certified diabetes educator. As diabetes education is an integral part of diabetes care and management, the professional with the Board certified in advanced diabetes management credential necessarily incorporates aspects of Diabetes self-management training into his or her practice, either directly or through referral to another qualified diabetes educator.

NUTRITION

EXERCISE

TRAVEL

WEATHER

Most people with diabetes do not understand the effect of weather on blood glucose control. When the weather is cold, glucose level may rise due to constriction of blood vessels. This constriction decreases the absorption of insulin from the subcutaneous tissue. Sometimes glucose level may drop during cold weather due to the amount of shivering that someone does. Shivering decreases glucose levels due to increased metabolic rate. Hot weather tends to lower glucose levels due to the dilation of the blood vessels. This helps the insulin to be absorbed faster than usual. Glucose levels frequently drop in the spring when temperatures begin to rise. This is something to be aware of so that it can be avoided or, at least, greatly limited.

HYPERGLYCEMIA

If a patient is treated with an insulin pump and glucose levels are elevated to > 250 mg/dL in the fasting state, the patient must be instructed to change the site immediately since he or she does not know how long insulin has not been infused for. If the patient is staying at home, he or she can correct the glucose and wait 1 to 2 hours for it to decrease to the normal range. If this does not happen, site needs to be changed immediately. The danger of not doing this is ketoacidosis and it can be avoided with careful attention to glucose levels > 250 mg/dL. At other times of the day, the correction should be made and glucose retested in 1 to 2 hours to make sure that glucose is coming down into the normal range. If moderate or large ketones are present or nausea, the correction should be doubled, as patients are very insulin resistant in this stage of ketosis. I strongly suggest that the patient then double the basal rate for 2 to 3 hours to bring the glucose back into the normal range quickly. If hyperglycemia occurs in those on injections, they simply need to correct with fast-acting insulin based on their correction factor.

SICK DAYS

When a patient with diabetes is ill, glucose levels tend to rise due to increased levels of cortisol. If glucose levels are elevated and a patient is on a pump, basal insulin should be increased by means of a temporary rate with an increase of 30 to 50%. If not on a pump, more frequent doses of fast-acting insulin need to be given every 3 to 4 hours. Some patients become hypoglycemic when ill. In this case, the temporary rate should be decreased by 30 to 50% until glucose levels begin to rise. If glucose levels remain low and insulin is discontinued for more than 1 hour, ketones can occur. If glucose continues to drop despite decreasing or stopping insulin, and patient is nauseous and/or vomiting, a small dose of glucagon (20 to 30 units) can be given to raise glucose level for a few hours. This may keep someone out of the hospital and at home where they are much more comfortable.

MENSTRUATION

In most women, glucose levels tend to rise the week before onset of menses. A different basal rate can be set into the pump to accommodate this rise in glucose. The basal profile can be changed back once menses begins. This makes life a little easier when the different basal profiles are already in the pump so that the woman does not need to do it on a monthly basis. If on injections, fast-acting insulin probably needs to be increased to cover meals and higher glucose values before onset of menses. The basal insulin is difficult to adjust because it takes a couple of days to equilibrate and this could cause hypoglycemia when menses occurs.

SMOKING

Everyone is aware of the long-term effects of smoking and these are all increased in those with diabetes. The acute effects of smoking are frequently overlooked. When someone with diabetes smokes a cigarette, blood vessels constrict and insulin is poorly absorbed. Most people who smoke grab a cigarette right after consuming a meal. This is extremely problematic since the insulin is not getting absorbed well, but the food is. This leads to high postprandial glucose levels. When smoking ceases, the blood vessels dilate causing the patient to absorb insulin quickly. This happens after the food has been digested causing subsequent low blood glucose levels. Patients who smoke with diabetes, therefore, have very erratic glucose levels with many hypo and hyperglycemic episodes.

MARIJUANA USE

Use of marijuana is similar to smoking cigarettes except it has the added effect of increasing appetite so people eat more food and either forget to cover it with insulin or just do not care. It is also difficult to detect hypoglycemia when high on marijuana.

COCAINE USE

When using cocaine, most people lose their interest in eating at all. They also forget to take insulin and begin to care only about the next fix. This is tragic for anyone, but for someone with diabetes it is particularly worrisome. If insulin is taken but the person does not eat, hypoglycemia occurs. If insulin is ignored, ketoacidosis occurs. Both are worrisome and scary.

ALCOHOL USE

Use of alcohol is tricky as well. This is the most commonly used drug. The problems with alcohol and diabetes are as follows:

1.  Drinking alcohol masks the symptoms of hypoglycemia.

2.  While detoxing alcohol the liver will not perform its usual job of glycogenolysis. If glucose falls dangerously low, the liver will not counter-regulate as it is too busy detoxing the alcohol and this is its first priority. It is important to remember that this is the one time that counter-regulation will not occur. Basal rates should be decreased by approximately 20% when going to sleep after a night of drinking. In this way, hypoglycemia is avoided. If a patient is on injections, a snack would need to be consumed before going to sleep. More than two alcoholic beverages should not be consumed by anyone but especially those with diabetes as it can be much more dangerous for him or her.

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