Real-world efficacy and safety of insulin degludec with mealtime rapid-acting insulin in type 1 diabetes in Indian pediatric population.

Background: Insulin Degludec (IDeg) is a new ultra-long-acting basal insulin that has not been yet evaluated in Indian pediatric population. We aim to evaluate the efficacy and safety of IDeg as basal-bolus therapy in Indian pediatric patients affected by type 1 diabetes mellitus (T1DM).

Methods: A total of 30 pediatric and adolescent patients (17 boys, 13 girls; 22 were pre-pubertal) with T1DM who were on IDeg once daily participated in the study. All the patients received IDeg for at least 26 weeks along with rapid-acting mealtime insulin and their pre- and post-baseline characteristics (anthropometric data (BMI), age, duration of diabetes), metabolic (HbA1C), insulin requirement (unit/kg body weight per day) and number of hypoglycemia episodes were recorded along with the daily self-monitoring of blood glucose.

Results: There was a significant decline in HbA1c, FPG and bolus insulin dose from baseline to 26 weeks in the overall population (HbA1c: 9.65 ± 1.998% to 8.60 ± 1.631%,  = 0.0014; FPG: 156.93 ± 42.373 mg/dL to 109.37 ± 28.531 mg/dL,  = 0.000004; bolus insulin dose: 0.49 ± 0.208 U/kg/day to 0.35 ± 0.155 U/kg/day,  = 0.00032). The basal insulin dose was significantly higher at 26 weeks compared to baseline dose (0.42 ± 0.134 U/kg/day to 0.46 ± 0.139 U/kg/day,  = 0.04219). There was no significant change in BMI at 26 weeks.None of the patients experienced any DKA episode for 26 weeks. 16.7% patients had experienced at least one symptomatic hypoglycemia episode. On CGMS among the patients who were shifted from Glargine to degludec hypoglycemia were reduced significantly (overall hypoglycemia: 1.92 ± 1.26 to 0.35 ± 0.49 episodes over 3 days,  = 0.0026 while nocturnal hypoglycemia: 0.92 ± 0.47 to 0.21 ± 0.42 episodes,  = 0.0021). None of the patients had severe hypoglycemia episode.

Conclusion: In our study IDeg is found to be safe and effective long-acting basal insulin that can be used in Indian pediatric population with T1DM. However further long term prospective studies are required to evaluate the long term effects.