Beneficial effects of flexible insulin therapy in children and adolescents with type 1 diabetes mellitus (original) (raw)
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Pediatric Diabetes, 2015
Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco A-M, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatric Diabetes 2015: 16: 164-176.
International Journal of Pediatric Endocrinology, 2011
Background: Children with type 1 diabetes (DM1) often use three daily (TID) injections with intermediate acting insulin at breakfast and bedtime, and rapid acting insulin at breakfast and dinner. Substituting the evening intermediate acting insulin with a long acting insulin analogue (LAIA) at dinner in a twice daily (BID) injection regimen may be as effective as a TID regimen. The objective of this pilot study was to compare HbA1c in children with DM1 using a BID regimen with a LAIA at dinner (intervention) to those using a standard TID regimen (control) over 6 months. Methods: Randomized controlled trial with main outcome measure being HbA1c at 0, 3 and 6 months. Secondary outcomes were frequency of adverse events (hypoglycemia, diabetic ketoacidosis, weight gain) and scores on the Diabetes Quality of Life Measure for Youth (DQOLY). Results: 18 subjects (10 control, 8 intervention). Mean years (standard deviations) for control and intervention respectively were: age at diagnosis of DM1 6.31 (2.91) vs 7.76 (3.22), duration of DM1 5.96 (4.95) vs 3.76 (3.37). No significant differences were seen in the mean HbA1c between control and intervention at 0 months [8.48(0.86) vs 8.57(1.13)], 3 months [8.47(0.50) vs 7.99(0.61)], or 6 months [8.42(0.63) vs 8.30(0.76)]. No significant differences were found between groups for frequency of adverse events or DQOLY. Conclusions: In this pilot study, incorporating LAIA in a BID regimen did not cause deterioration in HbA1c or increases in adverse events; suggesting that this may be a viable option for families where a more simplified insulin regimen would be beneficial and compliance may be improved.
Pediatrics, 2004
The aim of this study was to evaluate the metabolic effects of continuous subcutaneous insulin infusion (CSII) with flexible multiple daily insulin (FMDI; premeal lispro ؉ bedtime glargine) therapy as determined by glycosylated hemoglobin (HbA 1c), body mass index (BMI), and hypoglycemic episodes in a group of patients who made the transition from multiple daily insulin (premeal lispro ؉ bid ultralente) to either CSII or FMDI therapy. Methods. Data from 40 (27 female and 13 male) patients (10.1-17.8 years of age) who were on CSII and 40 age-and gender-matched (27 female and 13 male) patients (10.3-17.3 years of age) who were on FMDI were collected during regularly scheduled visits at a similar frequency over a 1-year period. Results. The total daily insulin dose did not change in CSII (0.97 ؎ 0.24 vs 0.91 ؎ 0.22 U/kg) and FMDI (0.98 ؎ 0.21 vs 0.97 ؎ 0.21 U/kg) patients, whereas the bolus: basal insulin ratio was significantly increased in both CSII (1.01 ؎ 0.43 vs 1.32 ؎ 0.52) and FMDI (1.07 ؎ 0.0.41 vs 1.29 ؎ 0.47) patients. The total cohort of CSII patients showed a decrease in HbA 1c from 8.4 ؎ 1.0% to 7.8 ؎ 0.8%, whereas the FMDI cohort did not show a significant change in HbA 1c (8.5 ؎ 1.1% to 8.2 ؎ 0.9%). However, 40% of the CSII group and 22.5% of the FMDI group showed >1.0% improvement in HbA 1c. Also, a similar number of patients in CSII (52.5%; 8.0 ؎ 1.1 to 7.2 ؎ 0.5%) and FMDI (47.5%; 8.0 ؎ 0.5% to 7.5 ؎ 0.4%) maintained or achieved target HbA 1c values <8.0%. The BMI increased significantly in the CSII group (21.6 ؎ 3.2 vs 23.0 ؎ 3.0 kg/m 2) but did not change in the FMDI group (21.9 ؎ 3.9 vs 22.6 ؎ 3.8 kg/m 2). There was a significant reduction in the rate of severe hypoglycemia (events/100 patientyears) in both cohorts: 20.6 to 8.2 in the CSII and 18.8 to 7.5 in the FMDI. Similarly, the rate of moderate hypoglycemia decreased in both CSII (68.3-35.4) and FMDI (56.3-30.4). Conclusions. CSII therapy resulted in a significant improvement in HbA 1c in the entire group, whereas FMDI therapy improved HbA 1c in only a subgroup of patients. However, almost half of the patients in each of the treatment groups maintained or achieved target glycemic control. Both CSII and FMDI treatment groups From the Children'
Journal of Clinical Research in Pediatric …, 2009
Objective: The purpose of this study was to compare the efficacy and safety of insulin glargine and detemir with NPH insulin in children and adolescents with type 1 diabetes mellitus (DM). Methods: Thirty four children and adolescents with type 1 DM (mean age 12.7 ± 3.4 years, diabetes duration 5.4 ± 3.0 years) were included in the study. All patients had been receiving intensive insulin therapy with insulin aspart and NPH for at least 6 months before switching from NPH to insulin glargine (Group 1, n=19) or detemir (Group 2, n=15). The medical records obtained within 6 months before and after treatment with insulin glargine and detemir were retrospectively reviewed and the data were compared in each group. Results: The mean age and duration of DM were similar in two groups (p>0.05). In both groups, switching from NPH to insulin glargine or detemir, resulted in a reduction in HbA 1c (p<0.05, for both). At the end of 6 months of treatment, no significant differences were observed between the glargine-and detemir-treated groups with respect to HbA 1c. Daily insulin requirements, mean fasting blood glucose levels and frequency of severe hypoglycemia before and after treatment with glargine and detemir were not significantly different (p>0.05, for both). Patients in the detemir treated group had less increment in body mass index (BMI) SDS at the end of 6 months of therapy compared to NPH and glargine treated patients (p>0.05, for both). No side effects were noted throughout the study. Conclusion: Both insulin glargine and detemir improved HbA 1c at short-term and proved to be safe and well tolerated in children and adolescents with type 1 DM.
Ankara Üniversitesi Tıp Fakültesi Mecmuası, 2008
Since there is limited number of studies in medical literature regarding the eff iciency of insulin detemir, decrease in number of night hypoglycemia, weight changes and the improvement the lipid profile in pediatric and adolescent age group, we planned a prospective study to analyze abovementioned issues. Material and Method: 15 diabetic patients (10 male) with insuff icient metabolic control and/ or morning hyperglisemia were included in to the study. The average age of the patients was 13.41±3.68 years and the average duration of diabetes was 5.03±1.74 years. Hemoglobin A1c levels, lipid levels and home glucose monitoring profiles were measured before and 32±2.32 months after substitution with insulin detemir. Results: After insulin detemir administration as basal insulin, the mean HbA1c values decreased from 9.08 % to 8.31 %. Total and LDL cholesterol values decreased significantly after detemir. The mean four point blood glucose profiles showed a significant decrease after the substitution with detemir. There was a decrease in the nocturnal hypoglycemia frequency and the rates were statistically significant diff er before and after detemir. Daily insulin doses, bolus/basal rates and body mass index SDS of patients were not changed significantly before and after detemir. Conclusion: In pediatric diabetic patients, insulin detemir as basal insulin is safe and significantly lowers glucose levels compared with NPH insulin. This pilot study showed that the substitution of NPH with detemir provides a better glycemic control without increased hypoglisemic events.
Diabetes Technology & Therapeutics
Objective: To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Research Design and Methods: Prespecified subanalysis of outcomes in adolescents and young adults aged 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Results: Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9-16, P < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference-12% [-2.9 h/day], P < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference-0.7% [-10 min/day], 95% CI-1.0% to-0.2%, P = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI-0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group. Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).
Institution of Basal-Bolus Therapy at Diagnosis for Children With Type 1 Diabetes Mellitus
PEDIATRICS, 2009
OBJECTIVE-We studied whether the institution of basal-bolus therapy immediately after diagnosis improved glycemic control in the first year after diagnosis for children with newly diagnosed type 1 diabetes mellitus. METHODS-We reviewed the charts of 459 children ≥6 years of age who were diagnosed as having type 1 diabetes between July 1, 2002, and June 30, 2006 (212 treated with basal-bolus therapy and 247 treated with a more-conventional neutral protamine Hagedorn regimen). We abstracted data obtained at diagnosis and at quarterly clinic visits and compared groups by using repeated-measures, mixed-linear model analysis. We also reviewed the records of 198 children with preexisting type 1 diabetes mellitus of >1-year duration who changed from the neutral protamine Hagedorn regimen to a basal-bolus regimen during the review period. RESULTS-Glargine-treated subjects with newly diagnosed diabetes had lower hemoglobin A1c levels at 3, 6, 9, and 12 months after diagnosis than did neutral protamine Hagedorn-treated subjects (average hemoglobin A1c levels of 7.05% with glargine and 7.63% with neutral protamine Hagedorn, estimated across months 3, 6, 9, and 12, according to repeated-measures models adjusted for age at diagnosis and baseline hemoglobin A1c levels; treatment difference: 0.58%). Children with longstanding diabetes had no clinically important changes in their hemoglobin A1c levels in the first year after changing regimens. CONCLUSION-The institution of basal-bolus therapy with insulin glargine at the time of diagnosis of type 1 diabetes was associated with improved glycemic control, in comparison with more-conventional neutral protamine Hagedorn regimens, during the first year after diagnosis.