Anne Peters, MD, and Lori Laffel, MD, MPH, Editors
Jane Lee Chiang, MD, Managing Editor
PEDIATRICS David Maahs, MD, PhD, and H. Peter Chase, MD
Standard of Care
A consensus statement on the use of insulin pump therapy, CSII, in youth with type 1 diabetes (T1D) is available, and will be referred to intermittently.
Who Should Use a Pump?
Pump therapy has been successfully used in pediatric patients of all ages, including preschoolers.2–5 The decision to initiate insulin pump therapy is made by parents, youth (referring to children or adolescents), and their diabetes care providers. In very young children, parents work with the medical team to make the decision. Important factors to consider are outlined in the Table 12.II.1.6 Fortunately, most health insurance companies require proof of a minimum of four blood glucose (BG) values per day in order to help fund CSII therapy. Subjects who do not routinely meet this criterion cannot safely use an insulin pump. In addition to the items in Table 12.II.1, many centers require knowledge of carbohydrate counting prior to initiating pump therapy. Only experienced pediatric diabetes care providers should treat youth initiating pump therapy….
Parameters Associated with Insulin Pump Use in Pediatrics
Youth (and parents of infants) usually state that the main reason for wanting to use a pump is to reduce the number of insulin injections per day.7 Clinical parameters to consider include:
- Reduction of A1C Levels: As with a meta-analysis of primarily adult studies, a reduction of 0.5% in A1C levels compared to prepump values is common, assuming proper patient selection for pump use and adequate follow-up.8–12 Other real-life data collected in the T1D Exchange Registry in the U.S. found a significant reduction (P <0.001) in A1C levels for all age-groups in 10,065 pump users, compared to 8,051 subjects using insulin injections.10 In a clinical trial of 485 people with T1D (STAR 3), youth and adults were randomized to remain on injections and BG checking or to use an insulin pump and a continuous glucose monitor (CGM).11 The latter group (for all ages) had statistically lower A1C levels by 0.5% (P <0.001) after one year. Youth who do more frequent BG checks and more frequent insulin boluses tend to have lower A1C levels.8–12
- Severe Hypoglycemia (SH): As with a meta-analysis of primarily adult studies, studies of youth using insulin pumps have shown a significant reduction in SH.9–13 In other real-life data, the T1D Exchange Registry has reported a lower incidence of SH in subjects using insulin pumps versus injections for people <50 years old.10 In contrast, the incidence of SH in the closely monitored STAR 3 trial was 13 episodes/100 person years in both the control and the pump/CGM groups.11
- Exercise is the number one factor associated with SH in children (particularly delayed hypoglycemia at night following heavy daytime exercise).14 A major advantage of CSII in youth is the ability to reduce or discontinue insulin during and following exercise to prevent hypoglycemia.15–16
- Diabetic Ketoacidosis (DKA): The incidence of DKA (6.2/100 person years) was similar to that of SH (6.6/100 person years) in 1,041 youth from 17 countries who used an insulin pump.13 In a study of 291 youth with T1D, the incidence of DKA was 1.4/100 person years in the year prior to initiation.9 After initiation of CSII therapy the incidence of DKA was 4.0/100 person years in the subsequent 1–9 years (mean 3.8 years; P = 0.08). The incidence in the same entire pediatric diabetes clinic (youth using and not using CSII) was 8/100 person years (with an incidence of 10/100 person years for youth not using CSII).17 Youth and families were screened and chosen to begin CSII therapy, resulting in the lesser likelihood of DKA. In the same pediatric diabetes clinic, 80% of cases of DKA occurred in 20% of the population.17 As DKA is the greatest cause of mortality in people under age 30 years, it is important to be selective in choosing youth for CSII therapy.18–19 For example, if rapid-acting insulin delivery is interrupted, hyperglycemia and ketonemia can develop within 3 h.20 In the absence of basal insulin, it is imperative that people using CSII routinely check their BG and, if elevated, blood or urine ketones. According preventative measures can then be taken. In other real-life data, the incidence of DKA in the first year of monitoring in the T1D Exchange Registry showed the highest rates in the 12–17 and the 18–25-year-old age groups using CSII therapy.10 The main cause of DKA in youth using insulin pumps is insertion-set occlusion with loss of available insulin.21 The use of a CGM to warn youth of high glucose levels essentially eliminated DKA in the STAR 3 trial.11 In summary, DKA may be slightly increased in youth after initiating CSII therapy; however, it is likely lower than in a general pediatric diabetes clinic population.9–17
- Psychosocial Parameters: Many youths who do not elect to use CSII report that they “do not want to be continually attached to something.”6 There have been many studies of patient satisfaction in youth before and after using CSII and the results are usually “improved” or “no changes.”4,22 A meta-analysis of the psychosocial impact of CSII (including five pediatric studies) found no consistent differences in anxiety, depression, quality of life, self-esteem, or family functioning.23 Further references to psychosocial issues can be found in the pediatric pump consensus statement.1
New Advances in Pump Therapy
Technologies will continue to advance for all people using insulin pumps. Patch pumps with no tubing between the pump and the infusion set have been popular with youth and will continue to improve. Incorporation of pump intelligence into a cell phone is already feasible but will require FDA approval for eventual use. The discontinuation of CSII with a low glucose level (Low Glucose Suspend) detected with CGM is already available in many countries and has been shown to result in less time spent in hypoglycemia.24–26
The use of CGM with a pump has been referred to above in the STAR 3 trial.11 The JDRF-CGM study demonstrated that use of a CGM in youth is only helpful when used 6 or more days/week.27 Unfortunately, 75% of youth do not succeed in this endeavor.10 The development of smaller, more comfortable, user-friendly, and more accurate sensors may help to encourage consistent CGM use. These technological advances will make CGM/insulin pump use, and life without SH and DKA, more likely for youth with T1D.
There are several published meta-analyses comparing insulin pumps and multiple daily injections (MDIs) as tools for intensifying glycemic control in adults with type 1 diabetes (T1D). These analyses of the randomized controlled trials in the literature indicate that adults using pump therapy have a 0.4–0.5% lower A1C than with MDI, without an increase in hypoglycemia and with lower insulin requirements. Several national and international clinical guide-lines recommend continuous subcutaneous insulin infusion (CSII) as a therapeutic option for adults with T1D with hypoglycemia unawareness and severe hypoglycemia or poor glycemic control. However, because of methodologic issues, the different meta-analyses regarding reduction of hypoglycemia with pump therapy have been conflicting. The meta-analysis conducted by Pickup, which was restricted to studies with a baseline rate of severe hypoglycemia of more than 10/100 episodes/patient years, showed that pump therapy was associated with a 2.9-fold reduction in severe hypoglycemia. Another meta-analysis, commissioned by the Endocrine Society, reached different conclusions that CSII is not associated with a significant reduction in either severe or nocturnal hypoglycemia. The validity of these conclusions is limited by the inclusion of short duration studies with low severe hypoglycemia incidence rates that would bias against detection of any treatment-related differences. In addition, the studies examined in this analysis predominantly involved use of older pumps that did not have bolus calculator software that can limit hypoglycemia from insulin stacking.
The potential complications of pump therapy such as device malfunction, infusion site problems, and ketoacidosis are often not reported in the clinical trials. Patient education about infusion site care and troubleshooting for unexplained hyperglycemia are crucial in decreasing the risk for ketoacidosis in pump users.
As in the pediatric population, the adults wishing to start on pump therapy need to be motivated and adherent with the requirements of intensive diabetes self-management and have an adequate diabetes knowledge base. In addition to the benefits of CSII as a tool to intensify glycemic control and minimize hypoglycemia, pump therapy can be advantageous in certain individual circumstances. These include preconception and pregnancy (see chapter 17), diurnal variation in basal insulin requirements (e.g., dawn phenomenon or steroid therapy) or low insulin requirements (better dosing accuracy and precision than injection therapy), and optimization of bolus coverage for gastroparesis and higher fat/complex carbohydrate meals that are more slowly absorbed. The published literature suggests that pump therapy is associated with improved quality of life; however, this has not been confirmed in all studies. This may relate to individual differences in perception about the trade-offs between potential benefits (such as increased lifestyle flexibility and reduced fear for hypoglycemia) relative to some of the negatives associated with wearing a pump (including body image concerns). In practice, ease of bolusing with the pump can be helpful to facilitate interprandial correction bolusing, coverage of snacks, and eating out at restaurants. Unrealistic notions, including the expectation that use of technology reduces need for attentiveness to self-care, need to be dispelled before patients start on pump therapy (see Table 12.II.2).
Relative contraindications to initiation of pump therapy include infrequent self-blood glucose monitoring (with related failure to detect and promptly treat unexplained hyperglycemia, and associated risk for ketoacidosis) and eating disorders with insulin omission and chronically elevated glucoses (with related failure to recognize hyperglycemia from insulin nondelivery). The development of cognitive impairment with compromised judgment, psychiatric problems with inattentiveness to self-care, and visual impairment (unless close family members can assist with pump/infusion set troubleshooting) can be grounds for discontinuing pump therapy in adults.
Considerations in calculating starting insulin doses for patients changing from MDI to pump therapy and optimizing both basal and bolus doses are covered in several publications, and therefore, will not be discussed here.
TROUBLESHOOTING ERRATIC GLUCOSE CONTROL IN THE PUMP PATIENT
There are several pump-specific issues the clinician should consider in the pump patient presenting with erratic glucoses:
1. Routine history should include questions about frequency of catheter kinking or dislodgement and frequency of catheter and reservoir replacement.
2. Routine examination should include evaluation of pump infusion sites for scarring and lipohypertrophy, which are not uncommon causes of erratic glucoses, especially in the long-term pump patient.
3. Review of blood glucose data should include evaluation to determine if erratic or elevated glucoses are more common in the period preceding set changes.
a. Priming history to determine frequency of reservoir change.
b. Bolus history to detect missed boluses.
c. Percent basal to bolus insulin. Basal > bolus in the patient with frequent hyperglycemia may indicate that bolus doses are being missed, whereas in the patient with frequent hypoglycemia this may indicate that high basal rates are contributing to hypoglycemia and would point to need to reevaluate basal settings.
d. Pump suspension or inappropriate basal rate reduction to determine if this is contributing to hyperglycemia.
To date only a few hospital facilities have introduced formal policies and procedures regarding the continued use of CSII pumps in patients with diabetes, however with more widespread use of pumps this is an issue that will need attention from hospital oversight bodies. Since most hospital staff do not have expertise with pump use, the patient needs to be alert and orientated and able to self-manage his or her pump (including administering boluses and changing reservoirs and infusion sets) in order to safely continue with pump therapy during hospitalization. Continued use of CSII pumps is contraindicated in patients who are critically ill or metabolically unstable. Because of the risk for overdelivery by insulin pumps that are in proximity to magnetic resonance imaging (MRI), it is critically important for hospitals and radiology facilities to have protocols to ensure that patients remove their pumps before entry into MRI suites.
There are always questions about whether information obtained from well-done randomized research studies vs. collection of real-life clinical data is more useful. The answer is, of course, that both are useful. It will be important to verify the lower A1C levels found in the STAR 3 Study in real-life situations.1 The T1D Exchange Registry, with large T1D patient numbers (~26,000 subjects), is now starting to fill this gap in the U.S.2 Funded by the Helmsley Charitable Trust, this registry plans to continue to provide longitudinal data to assist care providers and families of youth with T1D to select the best treatments available.
The next decade promises several technical improvements in pumps (including the introduction of smaller patch pumps with larger and prefilled insulin reservoirs) and infusion catheters that lead to more rapid insulin absorption, as well as advances of the insulin dosing software incorporated into insulin pumps. Current software incorporated into insulin pumps can be helpful in assisting patients with calculation of bolus doses to cover carbohydrates and correct hyperglycemia, and can be very important tools for reducing risk for hypoglycemia from stacking of insulin boluses. The insulin duration of action programmed into the pump software is a key factor in individualizing this function of the bolus calculator; if the duration of action is set too short (i.e., less than actual action time of the insulin bolus) the pump will indicate that there is less insulin on board than is the case, leading to dose stacking and hypoglycemia. In this regard it is important for the clinician setting the duration of action in the pump software to consider the pharmacodynamics, not the pharmacokinetics, of insulin boluses. The pumps currently in use apply different rules for this calculation; for example, the Insulet pump does not consider insulin from meal boluses when compensating for insulin on board. In addition to refinements of this function, future developments in pump software will include the incorporation of preprogrammable boluses to cover more complex meals and adaptive algorithms to refine basal insulin infusion rates.
The pharmacologic treatment tools and general approaches for T1D management have quickly and dramatically changed. In spite of this, the current treatment paradigm is still imperfect. The fundamental challenge, which separates T1D for all age groups from other chronic conditions, is the fact that for success, self-management will be required. Specific attention to diet and to the timing of insulin and vast attention to detail about all factors that impact blood glucose need to be appreciated by both patients and their families. The good news is many patients today can take advantage of these advances, especially in insulin and its delivery systems, and the burden of diabetes-related complications has dramatically lessened. The result is a new phenomenon, which we are just starting to appreciate: geriatric T1D. It is difficult to predict the public health magnitude this issue will be in 20 years, but it will likely be a major focus of public policy for organizations such as the American Diabetes Association. The already-developed tools described in this chapter are now allowing children and adults with T1D to be successful in all aspects of their life, an accomplishment never imagined just a few years ago.
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Continuous Subcutaneous Insulin Infusion (CSII): Pediatrics
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- Bergenstal R, Tamborlane W, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group: Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 363:311–320, 2010
- T1D Exchange Registry Symposium: Advanced Technologies and Treat-ments for Diabetes, February 2012. Barcelona, Spain
Used with permission by the American Diabetes Association. Copyright © 2013 American Diabetes Association.
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