OBJECTIVE -Our goals were to determine if continuous subcutaneous insulin infusion (CSII), compared with those continuing multiple daily injections (MDIs), can be safely used in young children, if those on CSII will have superior glycemic control, if subjects using CSII will have less hypoglycemia for their level of control, and if families using CSII will report an improved quality of life.RESEARCH DESIGN AND METHODS -We conducted a randomized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months' duration. Prospective outcomes included measures of overall glycemic control (HbA 1c and continuous glucose monitoring system), the incidence of severe hypoglycemia and diabetic ketoacidosis, the percent of glucose values below 3.9 mmol/l, and the parents' report of quality of life.RESULTS -The 19 subjects' ages ranged from 1.7 to 6.1 (mean 3.6) years, duration of diabetes ranged from 0.6 to 2.6 (mean 1.4) years, and baseline HbA 1c ranged from 6.7 to 9.6% (mean 7.9%). Seven subjects were male. Nine subjects were randomized to start CSII and 10 to continue on MDI. All baseline characteristics were well balanced. Overall metabolic control, diabetes quality of life, and the incidence of hypoglycemia were similar in the two groups. No subject had diabetic ketoacidosis, while one subject in each group had an episode of severe hypoglycemia. No CSII subject discontinued using the pump during or after the study.CONCLUSIONS -CSII can be a safe and effective method to deliver insulin in young children. Diabetes Care 28:15-19, 2005S ince its introduction in the late 1970s, continuous subcutaneous insulin infusion (CSII), or insulin pump therapy, has become an increasingly popular option for type 1 diabetes management (1,2), particularly following the push for improved metabolic control in the post-Diabetes Control and Complications Trial era (3). The potential advantages of such therapy over multiple daily injections (MDIs) include ease of insulin administration, improved metabolic control with reduced swings in glucose and decreased risk of hypoglycemia, better matching of insulin to carbohydrate intake, improved coverage of the dawn phenomenon and adjustment of basal insulin delivery at other times of the day, increased flexibility in daily living, and improved coping with diabetes (4,5). Potential disadvantages of CSII relative to MDI include increased cost, inconvenience of wearing a device, risk for subcutaneous infection at the pump infusion site, and diabetic ketoacidosis.CSII has traditionally been reserved for savvy adolescents and adults, but it is gaining more widespread acceptance in children as well (6 -12). One age-group in which the technology has been used sparingly but who may benefit from CSII is infants and toddlers. Although parents or other adult supervisors are available to oversee frequent glucose monitoring and multiple insulin injections, it is usually difficult to achieve near-normal metabolic control in this populatio...

Background: Nocturnal hypoglycemia is a significant problem. From 50% to 75% of hypoglycemia seizures occur at night. Despite the development of real-time glucose sensors (real-time continuous glucose monitor [CGM]) with hypoglycemic alarms, many patients sleep through these alarms. The goal of this pilot study was to assess the feasibility using a real-time CGM to discontinue insulin pump therapy when hypoglycemia was predicted. Methods: Twenty-two subjects with type 1 diabetes had two daytime admissions to a clinical research center. On the first admission their basal insulin was increased until their blood glucose level was Ͻ60 mg/dL. On the second admission hypoglycemic prediction algorithms were tested to determine if hypoglycemia was prevented by a 90-min pump shutoff and to determine if the pump shutoff resulted in rebound hyperglycemia. Results: Using a statistical prediction algorithm with an 80 mg/dL threshold and a 30-min projection horizon, hypoglycemia was prevented 60% of the time. Using a linear prediction algorithm with an 80 mg/dL threshold and a 45-min prediction horizon, hypoglycemia was prevented 80% of the time. There was no rebound hyperglycemia following pump suspension. Conclusions: Further development of algorithms is needed to prevent all episodes of hypoglycemia from occurring.