CLINICAL DIABETES
VOL. 17 NO. 3 1999


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FEATURE ARTICLE


A Primary Care Approach to Continuous Subcutaneous Insulin Infusion

Jeff Unger, MD


IN BRIEF

Pump therapy allows patients with type 1 diabetes the ability to live a flexible lifestyle while utilizing an insulin delivery device that most closely resembles the release of endogenous insulin. As insulin pump therapy becomes more popular, primary care phsyicians should be familiar with the importance of pump therapy, as well as the mechanics of the pump program. This article discusses the nuts and bolts of intensive insulin management as well as continuous subcutaneous insulin infusion therapy.

Insulin pump therapy, or continuous subcutaneous insulin infusion (CSII), has evolved from the desire to develop an insulin delivery system that simulates normal pancreatic function for patients with insulin-requiring diabetes. Each year, more than 30,000 new cases of type 1 diabetes are diagnosed.1 The Diabetes Control and Complications Trial (DCCT)2 demonstrated that improvement in glycemic control can significantly reduce by 60% the incidence of microvascular complications (retinopathy, neuropathy, and nephropathy) in patients with type 1 diabetes. In the DCCT, patients achieved intensive control either with multiple (three or more) daily insulin injections (MDI) or with the use of CSII. At the end of the study, 42% of all the intensively managed patients were using insulin pump therapy. Currently, more than 51,000 type 1 diabetic patients in the United States are using insulin pumps, a number that has been steadily increasing. (See Figure 1.) Patients, as well as physicians, are supporting the use of insulin pumps as a tool for the intensive management of diabetes.

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Figure 1. Pump usage in the United States. Insulin pump usage has increased from 6,600 patients in 1990 to more than 51,000 in 1998.

Approximately 90% of patients with diabetes are treated by primary care physicians whose specialty is neither diabetes nor endocrinology.3 Patients who are using insulin pumps are often very knowledgeable about their medical condition and about intensive insulin therapy. Primary care providers may be afraid to manage patients on insulin pumps because they lack the ability to guide their pump patients through many therapeutic decisions regarding intensive diabetes management. Some patients have been told that insulin pump therapy is experimental or that it is simply a fad that will pass in time.4 These patients are frequently encouraged to stop using their pumps and to consider twice daily insulin injections. Very few patients are willing to give up their pumps and return to an MDI regimen. As insulin pump usage increases, primary care physicians should understand the mechanics and principles of intensive diabetes and pump management.

Benefits of Insulin Pumping
MDI therapy is based on two different forms of drug delivery: 1) basal insulin and 2) bolus insulin. The basal insulin is usually given in the form of NPH, ultralente, or lente insulin, which have variable absorption rates ranging from 10 to 52% of the injected total dose.4 The purpose of basal insulin is to minimize fasting hepatic glucose production, which is exaggerated in diabetes. Short-acting regular or lispro (Humalog) insulin is given as a bolus before eating to minimize the postprandial rise in blood glucose.

Patients on MDI therapy must mix NPH and regular insulin 3­4 times daily in order to achieve acceptable glycemic control that mimics the insulin release in nondiabetic individuals. Insulin pump patients use only one type of insulin (regular or lispro), which has a much more predictable rate of absorption with better than a 2.8% day-to-day variation.4 Thus, CSII provides patients with the ability to mimic the normal glycemic response in both fasting and postprandial states.

In the past, insulin pump therapy was contraindicated in patients with severe, recurrent hypoglycemia. By using low basal insulin delivery rates, patients with frequent hypoglycemia or hypoglycemic unawareness can significantly reduce their incidence of hypoglycemia and even restore their awareness to the symptoms of hypoglycemia.5 Thus, CSII should be considered as an important indication for patients who are frequently hypoglycemic.6

Another indication for insulin pump therapy is extreme insulin sensitivity (total daily dose <20 U/day).5 The pump permits convenient administration of fractional insulin units (in 0.1-U increments), a level of precision not available with routine injection therapy.

Pump therapy allows patients a more normal and flexible lifestyle. Pump users can experience a degree of freedom in the timing of meals, work, sleep,  and physical activity not possible with MDI. Diabetes treatment protocols that rely on rigid dieting and activity schedules are unrealistic and inconvenient for most people. Adolescent pump users enjoy being able to sleep in on weekends and to eat meals at their convenience rather than timing meals according to the pharmacokinetic principles of NPH and regular insulin. Having this freedom with improved diabetes control is thought to be a major reason for the excitement and exuberance found among pump users.7

Pump Mechanics
Modern insulin pumps weigh only 4 ounces and are the size of a beeper. (See Figure 2.) The pumps use a flexible infusion set with catheter lengths of 24 or 42 inches that is inserted into the subcutaneous space of the abdomen or buttocks. Three types of needles can be used for insertion: a 24-gauge soft catheter (Sof Set), a Silhouette, or a 27-gauge bent needle.

fig-2.e

Figure 2. Insulin pump. A MiniMed 507 insulin pump is similar in size to a pocket beeper. The sof set infusion set is inserted into the subcutaneous space of the abdomen. The quick-release valve allows the pump user to disconnect the pump from the infusion site for bathing or intimate contact. Photo courtesy of MiniMed, Inc.

The infusion site is prepared with a bard pad IV prep pad before catheter insertion. Alcohol tends to cause irritation at the infusion site and should be avoided. Bent needles are placed into the subcutaneous space manually and then secured by a polyskin or opsite dressing. The Sof Sets use an auto insertion device and are virtually painless. Sof Sets are inserted at a 90-degree angle. The Silhouette consists of a soft cannula similar to the Sof Set, but is inserted at a 30-degree angle. Muscular individuals may prefer the Silhouette because the deeper Sof Set insertion may be more uncomfortable. Bent needles can remain in place for 2 days, while the Sof Sets and Silhouettes are used for 3 days. A 3-cc syringe containing up to 300 U of insulin is located in the back of the pump and must be changed with each new infusion set. Newer catheters have a quick-release feature allowing users to separate the catheter from the insulin reservoir on the pump for bathing, exercise, or intimate contact. The pump is powered by three disposable batteries that last approximately 6 weeks.

The pump's working parameters are predetermined and programmed into its memory by a physician or nurse educator. Each pump comes with several specified built-in alarms to prevent inadvertent insulin delivery or to warn patients if the infusion set becomes clogged or dysfunctional.8

Establishing the Pump Parameters
Before initiating any form of intensive diabetes management, a physician must first determine the approximate total daily dose (TDD) of insulin that the patient will require. This can be calculated by taking the patient's current weight in kilograms and multiplying it by 0.7. Thus a 70-kg man would require a TDD of insulin of about 70 X 0.7 = 49 U. Adolescent pump users require more insulin, ~ 1 U/kg/day, whereas older patients may be more insulin sensitive, requiring 0.5 U/kg/day. Because many patients require less insulin when beginning CSII,9 the actual TDD of insulin can be reduced by 10%.

Infusion from a pump is provided as either basal or bolus insulin. Half of the adjusted TDD of insulin is used as basal insulin, and half is used as bolus insulin.

To program the basal rate, 50% of the TDD is divided by 24 hours. A patient with a TDD of 48 U would devote 24 U to the basal rate, or 1 U/hour. Although most patients require between 1 and 3 basal rates, up to 24 basal rates can be programmed. If a patient has significant early morning hyperglycemia, a special basal rate can be programmed to counter the "dawn phenomenon," which occurs due to the production of growth hormone. By increasing the basal rate by 0.20.4 U/hour beginning 23 hours before rising, patients should be able to experience normal morning blood glucose levels when using regular insulin.10 If lispro is used, the basal rate adjustments may be programmed to begin 30 minutes before the anticipated rise in blood glucose levels.

Although actual basal rates are determined by physicians, patients can choose to initiate a temporary basal rate (TBR), which can bypass the predetermined insulin delivery rate for between 30 minutes and 18 hours. The TBR is useful for patients who experience postprandial hyperglycemia 36 hours after eating certain foods, such as pizza. A single bolus may well control postprandial blood glucose levels for the digestion of simple carbohydrates. However, complex carbohydrates may have delayed intestinal absorption resulting in higher-than-anticipated blood glucose levels hours after eating. Patients are instructed to place themselves on a TBR equal to 1.5 times their current basal rate for 46 hours following the ingestion of complex carbohydrates.

Patients may also decrease the basal rate in preparation for or while participating in intense exercise. Mild hypoglycemia can be treated by initiating a TBR, slowing the delivery of insulin and allowing blood glucose to rise over time. Thus, pumping patients can avoid "eating their way out of hypoglycemia."

Premeal insulin bolus doses should be determined according to: a) the preprandial blood glucose levels, b) estimation of the grams of carbohydrates that will be consumed during a meal, c) anticipated activity level after eating, and d) prior experience with insulin requirements for similar meals.11

If lispro is used in the pump, meal boluses can be administered when a meal begins. Boluses with regular insulin should be given 3045 minutes before eating to allow insulin to be broken down into active metabolites. Insulin injections should be timed so that peak insulin action coincides with peak carbohydrate absorption.

Meal Planning Using an Insulin Pump
Diabetes interferes with the metabolism of carbohydrates. Thus, the more carbohydrates consumed in a meal, the higher the anticipated rise in postprandial blood glucose, because carbohydrates are completely metabolized into glucose. Assuming that 50% of the TDD of insulin is used as bolus insulin, one can estimate the premeal bolus by providing 20% of the TDD for breakfast, 10% for lunch, and 20% for dinner. Most carbohydrates are consumed for breakfast and dinner.

Supplemental insulin can be administered with the routine preprandial bolus to correct any high blood glucose levels that are present before eating. The supplemental insulin dose is based on the "rule of 1,500."12 This rule calculates the patient's insulin sensitivity factor and allows the patient to predict how much 1.0 U of insulin will lower the blood glucose. The formula is depicted in Table 1. The supplemental insulin would be added to the normal meal bolus used to cover the consumed carbohydrates for the next meal or given separately in response to an elevated blood glucose level outside the patient's target range.

Table 1. Calculating Insulin Sensitivity for Supplemental Boluses
Divide 1,500 by the calculated total
    daily dose (TDD) of insulin

Example: TDD = 50 U
               1,500/50 = 30 mg/dl drop
                per 1.0 U of insulin

If target blood glucose is 100­120 mg/dl
and actual blood glucose is 200 mg/dl,
a supplemental bolus of 3.0 U is given
to bring glucose into the target range.

Determining insulin sensitivity is particularly important in helping patients avoid extremely labile swings in blood glucose (i.e., over-correcting for a high blood glucose and then becoming hypoglycemic several hours later).

Meal planning for patients with type 1 diabetes is an essential aspect of intensive diabetes management. Many patients and physicians are frightened by the term "diet," which implies little flexibility of meal choices for individuals with diabetes. Physicians are often too quick to prescribe the outdated "1,800-calorie American Diabetes Association diet" for all patients regardless of their age, weight, activity level, or total daily insulin requirements. People with diabetes require a careful balance of food intake, activity level, and insulin dosing. When patients learn the influence of various foods and activities on their glycemic control, they are able to balance these components of diabetes management at an optimum level.

When discussing meal planning with patients, physicians should emphasize the importance of sound nutritional practices, including avoiding excess intake of saturated fats and cholesterol, limiting salt consumption, and avoiding foods that have a high glycemic index, which could cause a rapid rise in blood glucose levels.12 Unless a patient is obese, there is no need to limit caloric consumption. Health care professionals are teaching intensively treated type 1 diabetic patients the art of carbohydrate counting.13 This concept requires patients to learn to dose insulin according to the amount of carbohydrates they consume.

To successfully count carbohydrates, patients must be familiar with the effects of carbohydrate consumption on their blood glucose. Practically speaking, 5 grams of fast-acting carbohydrate will raise the blood glucose by 20 mg/dl.12 Thus, a 30-gram carbohydrate meal will result in a 120 mg/dl rise in blood glucose within 90 minutes of consumption. Patients can be given an insulin-to-carbohydrate coverage ratio to help determine the dose of insulin required to cover the consumption of a given quantity of carbohydrate. This coverage ratio can be predicted by dividing 500 by the TDD of insulin. For example, if one uses 50 U/day of insulin, 1 U of regular or lispro insulin will cover 10 grams of carbohydrates.14 One U of insulin generally covers 10­15 grams of carbohydrates. In general, patients who are older or those with small body sizes are more insulin sensitive and will have a lower insulin-to-carbohydrate ratio.13

Patients should be encouraged to read food labels and estimate the amount of insulin required to cover the carbohydrate load of their meals. The more carbohydrates consumed, the more insulin will be required for preprandial bolusing. Patients should be aware that sugar-free foods are not carbohydrate-free and require insulin for consumption. One must not forget to bolus for snacks, such as popcorn at the movies or coffee with cream at the office. In short, carbohydrate intake must be matched with proper insulin bolusing.

In order to determine if insulin was bolused in the appropriate dose before a meal or snack, patients are encouraged to test their blood glucose 12 hours after eating. If the blood glucose level is within the range listed in Table 2, the patient has given the right amount of insulin for a given carbohydrate load. However, if the blood glucose level falls outside of the target range, the patient will know that consumption of the same amount of carbohydrates next time will require a different insulin bolus dose.

Table 2. Target Blood Glucose Levels (mg/dl) for Patients With Type 1 Diabetes4
Ideal Acceptable
Premeal 70105 70130
1-hour postprandial 100160 100180
2-hour postprandial 80120 80150
2:004:00 a.m. 80120 100140

Testing a 1- to 2-hour postprandial blood glucose will also allow the patient to use a compensatory bolus if blood glucose levels are outside of the target range. If the blood glucose is below the target range, fast-acting carbohydrates can be given or one can initiate a slower TBR, allowing blood glucose to return to normal. Patients are encouraged to keep a food diary to help them remember how much insulin will be required for different foods or meals.

Insulin pump patients must ask the following five questions4 before administering a premeal bolus of insulin:

  1. What is my blood glucose now?
  2. What type of food will I be eating, and is the meal high in carbohydrates and fats?
  3. How much insulin do I need to cover this meal and in what form shall the bolus be administered?
  4. What happened to my blood glucose the last time I gave insulin with this type of bolus under similar circumstances?
  5. Is anticipated post-meal exercise planned?

Meal consumption flexibility is a major advantage to using CSII. Few individuals are able to eat three meals per day on a scheduled basis. Insulin pump patients can eat when they choose and in the quantity they desire while providing precise doses of insulin to match carbohydrate intake.

Customizing the Insulin Bolus
Newer-generation insulin pumps (Mini-Med 507-C) allow patients to choose one of three different bolus techniques. A normal bolus provides an immediate delivery of insulin over a short interval (1 U delivered every 30 seconds). This type of bolus can be used if small amounts of carbohydrates are consumed or if a patient wishes to correct a blood glucose level that is outside of the target range.

A square wave bolus (Figure 3) allows a patient to give a single dose of insulin over a prolonged time period. Square wave boluses are helpful when eating foods that are high in both fat and carbohydrate because the fat delays carbohydrate absorption. If a normal bolus is given, circulating insulin levels rise rapidly and may peak before the carbohydrates are absorbed. This mismatch in insulin and blood glucose levels can result in postprandial hypoglycemia. Foods such as pizza and ice cream can be consumed with a square wave bolus given over 2­4 hours, thus avoiding erratic postprandial blood glucose levels.

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Figure 3. Square Wave Bolus. Photo courtesy of MiniMed, Inc.

The dual wave bolus (Figure 4) allows patients to combine the normal and square wave bolus techniques. Patients determine how much insulin they may need to cover a given meal. Using the dual wave bolus, 50% of the insulin dose is provided immediately at the onset of the meal, and the remainder is given over a 2- to 4-hour period of time. Thus, the dual wave bolus allows patients to provide a rapid rise in insulin levels and sustained high circulating insulin levels while a meal is consumed. In a nondiabetic individual, insulin is secreted in two phases similar to the manner in which the dual wave bolus functions.

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Figure 4. Dual Wave Bolus. Photo courtesy of Minimed, Inc.

Exercising With an Insulin Pump
A regular exercise program can potentially improve glycemic control in nearly all individuals with diabetes,15 as well as invigorate an individual's quality of life.16 The effect of exercise is dependent on several factors: 1) intensity and duration of exercise, 2) degree of physical conditioning of the individual, 3) pre-exercise carbohydrate consumption, 4) dosage and timing of premeal insulin, and 5) duration of diabetes.

The pre-exercise target blood glucose range should be 120180 mg/dl. Because exercise will increase the disposal of glucose into skeletal muscle cells, exercising with low blood glucose levels could increase the risk of developing exercise-induced hypoglycemia. Intensive exercise will result in an increase in hepatic glucose production, which can be used as an energy source for aerobic conditioning. Exercising with a blood glucose >250 mg/dl can increase one's risk of developing exercise-induced diabetic ketoacidosis11 because circulating insulin levels are low while hepatic glucose production increases to meet increased energy requirements.

If one's blood glucose is below the target range, 1530 grams of carbohydrate (such as a fruit or carbohydrate-enhanced "power bar") can be consumed before exercise. Before exercising, the patient must determine if the pump should be stopped or continued using a slower TBR. A trained athlete usually does not have to make any adjustments in the basal rate before exercise. However, untrained individuals should be advised to suspend the pump for the duration of exercise and to monitor themselves for hypoglycemia for up to 16 hours after the cessation of the exercise.6

Patients on insulin pumps can disconnect the pump temporarily in order to participate in water or contact sports. If regular insulin is used in the pump, patients can remain off the pump for up to 4 hours. If lispro is used, supplemental insulin or return to pump therapy should be initiated after 2 hours.

Insulin Pump Candidates
Any patient on insulin therapy is a  potential insulin pump candidate. Using an insulin pump correctly requires intensive training for both patients who will use the pump and physicians who will monitor them. Patients must understand that an insulin pump does not cure diabetes, but that it does allow considerable flexibility in the delivery of insulin. Blood glucose must still be monitored, often more than for patients using standard insulin injections.

Patients must have a written plan for treating sick days, diabetic ketoacidosis, and potential mechanical pump problems. Patients on CSII should always have access to injectable insulin and syringes in case their pump malfunctions.

Assessment of high blood glucose in insulin pump patients must also be addressed. High blood glucose levels may imply that insulin delivery is compromised or that an underlying infection may be present.

Occasionally, patients may wish to discontinue the pump for brief periods of time, requiring them to use alternative methods of insulin delivery. All pump patients should receive a written plan for any problem that may occur while using an insulin pump. Patients who are unwilling to monitor blood glucose, who have a history of noncompliance with treatment regimens, or who lack the financial ability to acquire the pump and supplies should not be initiated on CSII. Table 3 lists patients who would benefit from insulin pump therapy.

Table 3. Insulin Pump Therapy Candidates
  • Pregnant patients with insulin-dependent diabetes
  • Patients with hypoglycemic unawareness
  • Patients with poorly controlled diabetes
    and those experiencing wide glycemic variations
    on a day-to-day basis
  • Patients having a significant dawn phenomenon
  • Patients who need flexibility in their insulin regimen,
    such as those who work irregular shifts, travel frequently,
    or have erratic schedules
  • Adolescents who have poorly controlled diabetes and
    experience frequent diabetic ketoacidosis.17

Complications of Insulin Pumping
Any diabetes treatment plan carries potential risks to patients. Proper education, frequent blood glucose monitoring, and adherence to recommended guidelines are the cornerstones to managing problems unique to pump therapy and to preventing complications. Table 4 lists potential complications that insulin pump users must be able to recognize, troubleshoot, and manage.

Table 4. Insulin Pump Complications
  • Hyperglycemia and diabetic ketoacidosis
  • Hypoglycemia and hypoglycemic unawareness
  • Skin infections
  • Weight gain

Hypoglycemia. Patients undergoing intensive diabetes management are at increased risk for developing hypoglycemia. In the DCCT, severe hypoglycemia, defined as a hypoglycemic episode requiring the assistance of another person, was increased threefold in the intensive therapy group in comparison to the conventional group.2 Of severe hypoglycemic episodes, 53% occurred during sleep, and 35% occurred without warning while patients were awake. Patients who have had type 1 diabetes for >5 years often lose their counterregulatory mechanism for identifying and metabolically reversing hypoglycemia.5 These patients commonly develop hypoglycemic unawareness, the most dangerous consequences of which are impaired cognitive and disordered intellectual functioning. Operating a motor vehicle, caring for young children, and performing many tasks at one's place of work can be difficult while one is hypoglycemic.

One strategy to prevent hypoglycemia is to set higher target blood glucose goals. Insulin pump therapy offers several advantages for preventing hypoglycemia. If a patient on MDI experiences frequent wide glycemic swings of >150 mg/dl per day, initiation of insulin pumping will permit the physician to establish a higher target blood glucose range.5 Setting a lower-than-normal basal rate will allow blood glucose levels to rise, and the patient will experience less frequent episodes of hypoglycemia. For example, blood glucose targets can be set in the range of 120­180 mg/dl instead of 70130 mg/dl. After resetting the target blood glucose range and avoiding hypoglycemia for 68 weeks, the basal rate can be adjusted once again, allowing the physician to lower the target blood glucose range closer to normal. Hypoglycemic awareness can be reestablished in patients using this technique.4

Patients with frequent hypoglycemia who eat to raise blood glucose levels will often gain weight and require additional insulin to control their glucose levels. By initiating a TBR to slow the delivery of pumped insulin, minor hypoglycemia can be treated without food supplements and weight gain. Commercially available glucose tablets contain 5 grams of carbohydrate. Each tablet should increase blood glucose by 20 mg/dl and should be carried by all patients using insulin. Patients and their families should also be instructed on the use of glucagon emergency kits for treating severe hypoglycemia.

Home blood glucose monitoring is essential for preventing and identifying hypoglycemia. Pump patients should always check their blood glucose before eating, at bedtime, before and after exercise, before driving, and occasionally 3 hours after going to bed in order to identify and treat nocturnal hypoglycemia. Home blood glucose monitoring should become simplified when continuous subcutaneous glucose monitoring devices now in development reach the market.

Skin infections. Skin irritations and infections may appear at the infusion site. Abscesses can develop at the infusion site that are culture-positive for staphylococcus aureus.4 Large abscesses must be surgically drained and treated with appropriate antibiotics. Infections occur because patients fail to use a sterile technique to insert the infusion set through the skin or leave the infusion set in for more than 2 days for bent needles or 3 days for Sof Sets or silhouettes™. If pain or redness appears at the infusion site, the infusion set and site need to be changed immediately to prevent a skin infection.

Unexplained hyperglycemia. Unexplained hyperglycemia is a high blood glucose level that persists for >4 hours with no obvious reason. Usually, the patient is not ill but performs a routine blood glucose test only to be surprised that the reading is in the 300400 mg/dl range. When unexplained hyperglycemia is present, the patient must be able to troubleshoot the insulin pump and correct the high blood glucose with supplemental insulin. Since many pump users employ lispro, even a minor interruption of insulin delivery may result in hyperglycemia or diabetic ketoacidosis.5 The causes of unexplained hyperglycemia can be found in Table 5.

Table 5. Causes of Unexplained Hyperglycemia in Insulin Pump Users
Insulin Pump
  • Basal rate programmed incorrectly
  • Pump malfunction; syringe is not advancing

Syringe

  • Insulin leakage
  • Needle becomes dislodged from infusing site
  • Air/blood is in the infusion set
  • Needle has been placed in scar tissue; insulin cannot be delivered,
    and a high pressure alarm will sound
  • Kinked tubing prevents insulin delivery
  • Insulin occlusion due to use of nonbuffered insulin in the infusion set

Infusion Site

  • Redness, irritation, inflammation will alter insulin absorption
  • Underlying systemic infection causes insulin resistance

Insulin

  • Insulin has been exposed to extreme temperatures and has been
    deactivated
  • Insulin has expired
  • Improper mealtime bolus of insulin was used

As soon as a patient determines the presence of unexplained hyperglycemia, a bolus of insulin should be administered via the pump. The supplemental dose of insulin should be determined by the "rule of 1,500" and should be calculated to lower blood glucose back into the target range. One hour after administering the supplemental insulin dose, a blood glucose determination should be made. If the blood glucose is rising despite the bolus, the patient must administer a subcutaneous injection of insulin to lower the blood glucose and change the entire infusion set. If nausea, vomiting, hyperglycemia, and ketonuria are all present, the patient must contact the physician and receive treatment for diabetic ketoacidosis (DKA). An underlying cause of DKA, such as infection, should be pursued.

Weight gain. Weight gain has been associated with intensive insulin regimens. In the DCCT, subjects using intensive management gained an average of 5.1 kg over the study period compared to an average weight gain of only 2.4 kg in the conventionally treated subjects.2 The largest weight gain was associated with the greatest decreases in glycosylated hemoglobin levels and increased frequency of severe hypoglycemia. The weight gain that occurs when blood glucose control is improved is due to a reduction of caloric loss in the form of glycosuria. Weight control may be facilitated with CSII since patients do not need to eat as frequently or eat between-meal snacks. Pump users often choose to skip meals without affecting their glycemic control.15

Pumping Insulin During Pregnancy
Hyperglycemia in pregnancy can result in congenital abnormalities.16 The intrauterine mortality associated with DKA approaches 50%.16 CSII is best initiated before conception but can also be started during pregnancy. The basal and bolus rates will need to be updated frequently due to accelerated catabolism, increasing insulin demand, and intensified production of counterregulatory hormones that have anti-insulin action during pregnancy.

Target blood glucose ranges during pregnancy are 70110 mg/dl fasting and >120 mg/dl 2 hours postprandial. Special precautions and protocols must be used during pregnancy to prevent DKA. Due to the high rate of fetal mortality associated with DKA, a small bedtime injection of NPH insulin (0.2 U/kg) can be administered at bedtime in case the infusion of insulin is interrupted during sleep.16

Choosing Pump Therapy
The indications for CSII include the need for improved glycemic control and a patient's desire to lead a more flexible lifestyle, especially when daily schedules are unpredictable. Appropriate candidate selection is essential to the success of pump therapy. (See Table 6.)

Table 6. Candidates Who Should Be Considered for Insulin Pump Therapy
Prerequisites
  • Patient has demonstrated ability to self-monitor blood glucose levels and adjust
    insulin doses based on preprandial blood glucose levels and anticipated future activity
  • Patient is motivated to achieve and maintain improved glycemic control using
    intensive insulin therapy

Pump candidates should also have at least one of the following:

  • Glycosylated hemoglobin level >7.0%
  • History of wide glycemic excursions of >150 mg/dl per day
  • Dawn phenomenon, during which fasting blood glucose levels are often >200 mg/dl
  • Frequent variations in work schedules, mealtimes, and/or activity level, which
    confound the degree of regimentation required to self-manage diabetes with MDI
  • History of frequent hypoglycemia or hypoglycemic unawareness
  • Preconception or pregnancy with a history of suboptimal glycemic control
  • Suboptimal glycemic and metabolic control post-renal transplant

Pump therapy requires that patients possess certain physical, intellectual, and motivational attributes to ensure optimum benefit and to reduce risks. Physical abilities are needed to accurately perform blood glucose monitoring and to carry out the technical components of insulin pump use. Patients must be able to troubleshoot the pump and infusion set should problems with insulin delivery arise. Patients who take an active role in using pump therapy will have the best short- and long-term outcomes.

Summary
Intensive insulin therapy can be achieved with MDI or by use of CSII pumps. Patients are becoming more aware of insulin pump therapy through information provided by physicians, as well as through resources such as the Internet and publications from the American Diabetes Association. Primary care physicians will undoubtedly see more patients on insulin pumps and patients requesting to have their diabetes better managed with CSII. Physicians who wish to advance their knowledge of diabetes management should become familiar with the nuts and bolts of intensive insulin management and consider learning more about pumps from the manufacturers.

As physicians, we have the responsibility to design programs to teach and manage our patients with diabetes that will prevent long- and short-term complications as well as provide flexibility for busy lifestyles. Each patient's therapy should be individualized for achieving optimal health and enhancing personal freedom. Insulin pump therapy is an exciting option for patients striving for improved diabetes self-care.


REFERENCES

1LaPorte RE, Matsushima M, Chang YF: Prevalence and incidence of insulin-dependent diabetes. In Diabetes in America, 2nd edition. Harris MI, Ed. Bethesda, Md., National Institutes of Health, 1995, p. 37.

2The DCCT Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:97786, 1993.

3The DCCT Research Group: Implementation of treatment protocols in the Diabetes Control and Complications Trial. Diabetes Care 18:36176, 1995.

4Unger J, Fredrickson L: A primer on intensive diabetes management and insulin pump therapy. Primary Care Rep 3:917, 1997.

5Bode, BW, Steed RD, Davidson PC: Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes. Diabetes Care 19:32427, 1996.

6Davidson PC: Bolus and supplemental insulin. In The Insulin Pump Therapy Book : Insights from the Experts. Fredrickson L, Ed. Sylmar, Calif., MiniMed, 1995, p. 5971.

7Hirsch IB, Farkas-Hirsch R, Cryer PE: Continuous subcutaneous insulin infusion for the treatment of diabetic patients with hypoglycemia unawareness. Diabetes Nutr Metab 4:4143, 1991.

8Mecklenberg RS: Acute complications associated with insulin infusion pump therapy: report of experience with 161 patients. JAMA 252:326569, 1984.

9Lauritzen T, Pramming S, Decker T, Binder C: Pharmacokinetics of continuous subcutaneous insulin infusion. Diabetologia 24:32629, 1983.

10Shapiro J, Wigg D, Charles MA, Pereley M: Personality and family profiles of chronic insulin-dependent diabetic patients using portable insulin infusion pump therapy: a preliminary investigation. Diabetes Care 7:13742, 1984.

11Skyler JS: Continous subcutaneous insulin infusion (CSII) with external devices: current status. In Update in Drug Delivery Systems. Ensminger WD, Selam JL, Eds. Mount Kisco, NY, Futura, 1989, p.16383.

12Unger J: Principles of intensive insulin therapy. Hosp Phys 11:820, 1994.

13Farkas-Hirsch R, Hirsch IB: Continuous subcutaneous insulin infusion: a review of the past and its implementation for the future. Diabetes Spectrum 7:80-84, 13638, 1994

14American Diabetes Association: Position statement: Nutrition recommendations and principles for people with diabetes mellitus. Diabetes Care 22(Suppl. 1):S4245, 1999.

15Strowig SM: Initiation and management of insulin pump therapy. Diabetes Educ 18:50-59, 1993.

16Marcus A: Patient selection for insulin pump therapy. Pract Diabetol 11:1218, 1992.

17Steindel BS, Roe TR, Costin G, Carlson M, Kaufman FR: Continuous subcutaneous insulin infusion (CSII) in children and adolescents with chronic poorly controlled type 1 diabetes mellitus. Diabetes Res Clin Pract 27:199204, 1995.


Jeff Unger, MD, is director of the Chino Medical Group Diabetes Intervention Center in Chino, Calif., and an assistant professor of family medicine at Loma Linda University School of Medicine in Loma Linda, Calif.


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