Use of insulin glargine in children under age 6 with type 1 diabetes.

AIM: Children under 6 yr have the highest incidence of severe hypoglycemia (SH) and the greatest likelihood of brain damage from SH. The purpose of this study is to evaluate the use of insulin glargine (Lantus in children under age 6 with type 1 diabetes (T1D). METHODS: The electronic medical records were reviewed for patients under age 6 during the first 6 months of insulin glargine therapy and compared with age, sex, and duration of diabetes for matched control patients on neutral protamine Hagedorn (NPH) insulin. Data from 128 subjects (32 male pairs and 32 female pairs) were collected relating to the incidence of severe and non-severe hypoglycemic events, hemoglobin A1c (HbA1c) values, body mass index (BMI), and daily insulin dose. Additionally, parents were asked to complete a diabetes Quality of Life (QoL) survey. RESULTS: In the 6 months before the study period, the glargine group had 16 SH events compared with three in the 6 months post-glargine. The comparison (NPH) group had seven and six SH events in their respective 6-month periods. Nighttime SH events in the glargine group decreased from 12 prestudy events to one during the study period. The average daily insulin dose in the glargine group was higher than that in the NPH group (0.8+/- 0.2 vs. 0.7+/- 0.2 U/kg/day; p=0.03). The HbA1c values, BMI, and QoL responses were not significantly different between the two groups. CONCLUSIONS: SH was decreased, particularly at night (from 12 episodes to one), after the introduction of glargine in young children with T1D.

Response to nocturnal alarms using a real-time glucose sensor.

BACKGROUND: The objective of this study was to determine how subjects responded to alarms for hypo- and hyperglycemia while they were sleeping. RESEARCH DESIGN AND METHODS: Twenty subjects with type 1 diabetes (4-17 years old) were admitted to a clinical research center for approximately 24 h. Each subject wore two GlucoWatch G2 Biographers (GW2B) (Cygnus, Inc., Redwood City, CA) and was videotaped using an infrared camera from 9 p.m. to 7 a.m. The videotapes were reviewed to determine if the GW2B alarms were audible on the tape and to document the subject's response to the alarms. Because many alarms can occur surrounding a change in blood glucose, GW2B alarm "events" are defined as a one or more alarms separated from previous alarms by more than 30 min. RESULTS: Downloaded data from the biographers identified 240 individual alarms, 75% of which occurred while the subject was sleeping. Of the 240 alarms 68% were audible on the videotape. Subjects awoke to 29% of individual alarms and to 66% of alarm events. Subjects 4-6 years old responded to 17% of alarms, 7-11 year olds responded to 20% of alarms, adolescents responded to 53% of alarms, and parents responded to 37% of alarms. Subjects awoke to 40% of the first alarm during the night, but to only 28% of subsequent alarms. There were 11 events when the glucose was confirmed to be < or = 70 mg/dL, and in each case the subject was awoken. Fifty-five percent of alarm events occurred when there was no hypo- or hyperglycemia confirmed by a reference glucose value. CONCLUSIONS: Subjects awoke to 29% of individual alarms and to 66% of alarm events. Subjects awoke during all alarm events when hypoglycemia was confirmed, but there was a high incidence of false alarms.

Real-time glucose sensing using transdermal fluid under continuous vacuum pressure in children with type 1 diabetes.

BACKGROUND: This study was designed to evaluate the accuracy and tolerance in children of an experimental device for continuous glucose monitoring. This real-time glucose sensing (RTGS) system measures transdermal fluid glucose through micropores in the stratum corneum that are kept open by continuous vacuum pressure. DESIGN AND METHODS: A comparison of self-monitored blood glucose values and RTGS values was obtained in 110 children with type 1 diabetes ranging in age from 2 to 18 years. The RTGS system was worn for two periods of 48-56 h each. Children went home and had no restrictions in diet during the data collection period. Physical activity also was not restricted, with the exception of swimming or other water immersion that would interfere with or damage the RTGS. RESULTS: The procedure for obtaining transdermal fluid was well tolerated, and adequate flow was maintained out to 48 h or more in most study participants. Comparison of RTGS glucose and self-measured glucose paired values (3,064 values) indicated 69% within Clarke Error Grid Zone A and 21% within Grid Zone B when device tracking was maintained. Errors in tracking occurred with displacement of the vacuum device, or damage to the glucose sensor. CONCLUSIONS: Transdermal fluid glucose measurements using a prototype device system were well tolerated by children with type 1 diabetes and showed good correlation with concomitant capillary glucose blood measurements. Changes in glucose as tracked by the RTGS system appeared accurate. The durability of the prototype system will need improvement.

Redefining the clinical remission period in children with type 1 diabetes.

PURPOSE: To redefine the clinical remission period for different aged children receiving the current standard of diabetes care. METHODS: An electronic patient records system was used to identify 552 children newly diagnosed with type 1 diabetes (T1D) from 1997 to 2001 who had an initial hemoglobin A1c (HbA1c) value at the time of diagnosis and at least one other value measured in the ensuing year. The insulin dosage previously used to define the remission period [<0.5 units per kg body weight per day (U/kg/d)] was evaluated for the different aged children. RESULTS: The mean insulin dosages for all age groups were >0.5 U/kg/d by 9 months after diagnosis. The mean HbA1c values were above 8% by 6 months after diagnosis for the 6-9 and the 10-12 yr age groups and by 9 months after diagnosis for the >or=13 yr age group. The percentage of children

Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy.

OBJECTIVE: To identify possible causes of suboptimal glycemic control (ascertained by hemoglobin A1c [HbA1c] level) in youths using insulin pump therapy. METHODS: Forty-eight youths who were receiving insulin pump therapy for > or =6 months, and who were using insulin pumps and blood glucose meters with data that could be downloaded at our facility, are included in this cross-sectional study. Possible causes of suboptimal glycemic control were evaluated by using 4 information sources: 1) insulin pump data downloads; 2) glucose meter data downloads; 3) patient/family questionnaire about insulin bolusing habits, eating habits, exercise, and blood glucose testing habits; and 4) a physician questionnaire. Physicians completed the questionnaire during the patient interview after reviewing the downloaded information and discussing these results with the patient/family. RESULTS: The mean (+/- standard deviation) age of participants was 15.3 (+/-3.0) years (range: 7-20 years), and the mean (+/- standard deviation) duration of type 1 diabetes and continuous subcutaneous insulin infusion was 8.2 (+/-4.0) and 1.9 (+/-1.0) years, respectively. Patients who missed <1 bolus per week had a mean (95% confidence interval) HbA1c level of 8.0% (7.7, 8.3), whereas those who missed > or =1 mealtime boluses per week had a mean HbA1c level (95% confidence interval) of 8.8% (8.6, 9.1). No significant relationships were found between HbA1c levels in males and females, the amount of exercise per week, or bolusing before insulin pump disconnection for exercise. Although not significant, a trend was found for those who missed <1 bolus per week to perform more blood glucose tests per day and for those who bolused before a meal rather than after to have lower HbA1c levels. Significant correlations were found between HbA1c levels and the number of missed mealtime boluses per week (r =.414) and mean blood glucose levels (r =.70). CONCLUSION: Missed mealtime insulin boluses seem to be the major cause of suboptimal glycemic control in youths with diabetes receiving continuous subcutaneous insulin infusion therapy.