Joann Ahern

Persistence of Benefits of Continuous Subcutaneous Insulin Infusion in Very Young Children With Type 1 Diabetes: A Follow-up Report

Objective. Use of continuous subcutaneous insulin infusion (CSII) has increased dramatically in recent years, and pump therapy has been shown to be a safe and effective alternative to multiple daily injections in adults and older pediatric patients with type 1 diabetes. Its use in very young children, however, has been limited, although this group might be expected to benefit the most from CSII. The objective of this study was to analyze the CSII efficacy and safety data in very young children with type 1 diabetes from our Diabetes Clinic database. Methods. Glycosylated hemoglobin (HbA1c), severe hypoglycemia (SH), and ketoacidosis (DKA) in the year before CSII were compared with corresponding values during pump treatment in all children who started CSII before age 7. Results. Sixty-five children (mean age: 4.5 y at CSII initiation; range: 1.4–6.9 years; 28 girls; 3 black, 1 Hispanic) were analyzed for >162 patient-years of follow-up. Mean HbA1c (7.4 ± 1.0 prepump) decreased to 7.0 ± 0.9 after 12 months of CSII and continued to improve even after 4 years on CSII. The rate of SH was reduced by 53% (from 78 to 37/100 patient-years). Children who received daytime care from paid caregivers (n = 26) experienced significant reductions in HbA1c and hypoglycemia frequency. There were no episodes of DKA requiring emergency treatment in the year before CSII and 4 episodes (4 per 100 patient-years) after transition to pump. Conclusions. CSII is a durable and effective means of optimizing glycemic control in very young patients with type 1 diabetes and may be superior to multiple daily injections in minimizing the risk of severe hypoglycemia in this age group. Employment of paid caregivers does not preclude safe and effective use of CSII.

IMPLICATIONS AND RESULTS OF THE DIABETES CONTROL AND COMPLICATIONS TRIAL

After almost 60 years of debate, the DCCT demonstrated that intensive management that is able to lower blood glucose and HbA1c to levels that are close to normal markedly lowers the risk for and progression of the microvascular and neuropathic complications of IDDM. The challenge to pediatricians and other clinicians is to achieve and maintain such stringent treatment goals in children and adolescents, who are especially difficult to manage, without causing an unacceptably high rate of severe hypoglycemia. Translation of DCCT recommendations into clinical practice is best accomplished by multidisciplinary teams who are experienced in the management of young patients with IDDM and are willing to use the variety of unconventional treatment regimens that may be required. Patients and families must be instructed on ways to reduce the risk for hypoglycemia and be able to recognize and treat hypoglycemic events that require assistance. New agents, such as insulin lispro, may enhance the ability to achieve strict glycemic control, but the treatment remains a burden. Nevertheless, in patients in whom treatment is successful, the improvement in long-term prognosis more than justifies the investment in time, effort, and resources.

Emerging evidence for the use of insulin pump therapy in infants, toddlers, and preschool‐aged children with type 1 diabetes

Abstract:  Insulin pump therapy has, within the last 10 years, emerged as an increasingly popular modality of treatment to achieve intensive glycemic targets in type 1 diabetes (T1D). The evidence for the benefits of pump therapy has been demonstrated in adults and adolescents; however, until recently there has been a paucity of studies examining the efficacy and safety in pump therapy in very young children. The purpose of this article is to discuss the rationale for insulin pump therapy in infants and toddlers, review the available studies of pump therapy in this population, and show that the data support the use of insulin pumps in our very youngest of patients.

The Impact of the Trial Coordinator in the Diabetes Control and Complications Trial (DCCT)

The Diabetes Control and Complications Trial (DCCT) is a multicenter, randomized clinical trial studying the effects of two different diabetes regimens on the development and progression of early vascular complications in persons with insulin-dependent diabetes mellitus (IDDM). All of the centers have a Trial Coordinator. We administered a self-report questionnaire to each center to document the different activities for which the Trial Coordinator assumed responsibility, in successfully orchestrating the trial. All Trial Coordinators were responsible primarily for recruitment, screening, medical management, education and training, and adherence and administration. Although documentation indicated that the Trial Coordinator was responsible for all of the above activities, the original applications reflected that very few of the Principal Investigators anticipated such a wide variety of duties. A Trial Coordinator was named in only 13 of the 21 applications and of these, only 6 actually assumed the position. This study points out the need to develop a means to define characteristics, background, and training appropriate for candidates for a Trial Coordinator position in future studies.

Insulin Pump Therapy in Childhood Diabetes Mellitus

The current goals for the therapy of children and adolescents with type 1 diabetes mellitus are to achieve near-normal glycemia, minimize the risk of severe hypoglycemia, limit excessive weight gain while achieving adequate growth, improve quality of life for both the patients and their families, and delay or prevent vascular complications. Insulin pump therapy provides a treatment option that can significantly aid in achieving all of these goals across all age ranges of pediatric patients. Continuous subcutaneous insulin infusion (CSII) pump therapy can provide greater flexibility in the timing of meals and snacks, has programmable basal rates to optimize overnight glycemic control, can reduce the risk of exercise-induced hypoglycemia, and enhances the ability of the patient and the family members to achieve acceptable diabetes control. In pediatrie patients, CSII has been shown to reduce both glycosylated hemoglobin levels and the frequency of severe hypoglycemia without increasing the risk of diabetic ketoacidosis. The effectiveness of CSII, improvements in pump technology, and the availability of very rapid-acting insulin analogs have fueled a dramatic increase in the use of this therapy.This review presents practical guidelines for the selection of patients, initiation of treatment and patient education, as well as guidelines for use while exercising and at school. Keys to the success of CSII are to have a multidisciplinary team of clinicians who are expert in the care of children with diabetes, and patients and families who are able to carry out the tasks of intensive treatment, including self-monitoring of blood glucose levels, carbohydrate counting, and infusion pump management. Patients and parents need to be able to recognize and treat hypoglycemia, and prevent the development of ketoacidosis. School personnel need to be involved in the treatment plan and individual algorithms developed for periods of extra exercise and activity. The recent introduction of methods for continuous glucose monitoring provides a new means to optimize the basal and bolus capabilities of CSII and offers hope for the development of a feedback-controlled artificial pancreas.

Use of continuous subcutaneous insulin infusion in young adolescents with diabetes mellitus: a case study.

Continuous subcutaneous insulin infusion (CSII) was initiated in a young female adolescent with severe insulin resistance, decreased growth velocity, and poor metabolic control. The patients insulin dose had been 3 u/kg/day, and it was hypothesized that her insulin requirements would be much less when only regular insulin was used. Because of the potential risk of severe hypoglycemia from giving regular insulin in amounts equivalent to her injection total daily dose as a constant subcutaneous infusion, the patient was hospitalized to begin pump therapy. Hourly glucose levels were collected for 24 hours to determine insulin requirements with this therapy. The patient subsequently required a significantly reduced dose of insulin (1.2 u/kg/day) with CSII, and her growth velocity improved. Metabolic control based on glycosylated hemoglobin levels also improved. Insulin pump treatment proved to be a viable solution for this young adolescent who required large doses of insulin to maintain reasonable control. Challenges of using this type of therapy in young patients are discussed.

Lessons from glucose monitoring at night.

The current popularity of multiple-dose insulin regimens aimed at strict glycemic control has underscored the importance of maintaining fasting glucose levels in diabetic patients as close to normal as possible. Failure to achieve this goal often results in the perpetuation of hyperglycemia for the remainder of the day or attempts at corrective measures with supplemental doses of insulin that often miss the mark. The therapeutic obstacle imposed by fasting hyperglycemia is best appreciated in the context of its pathogenesis, namely, hepatic glucose overproduction. Once the livers glucose-synthesizing capacity has been activated in the morning, it is not readily suppressed by injections of insulin or the rise in glucose concentration that accompanies meals (1,2). The inappropriate persistence of endogenous glucose release during breakfast further accelerates glucose delivery to the bloodstream, well beyond the capacity of peripheral disposal mechanisms that are known to be impaired in diabetic patients (3). The net effect is a further expansion of the extracellular glucose pool that requires either many hours to reverse or large doses of insulin to overcome peripheral insulin resistance. Because these depot injections are determined empirically and cause prolonged elevations in circulating insulin, such attempts at compensation may lead to hypoglycemia later in the day.