NCT04664764

Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

The Effect of Long- and Intermediate-acting Insulins on Glycemic Control and Risk of Hypoglycemia Among Toddlers and Preschool Children With Newly Onset Type 1 Diabetes Mellitus: A Randomized Three Armed Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. Objectives: To compare the effectiveness of insulin degludec to insulin glargine and NPH in toddlers and preschool children with T1D in terms of glycosylated hemoglobin(HbA1C) and frequency of hypoglycemic episodes.

Conditions

• Type 1 Diabetes Mellitus With Hypoglycemia
• type1diabetes

Interventions

Type	Name	Description
DRUG	Degludec	Basal insulin comparison
DRUG	Glargine	Basal insulin comparison
DRUG	NPH insulin	Basal insulin comparison

Timeline

• Start date: 2019-02-21
• Primary completion: 2021-02-28
• Completion: 2021-03-10
• First posted: 2020-12-11
• Last updated: 2021-02-16

Locations

1 site across 1 country: Egypt