Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Phase 4

• Conditions: Type 1 Diabetes Mellitus With Hypoglycemia; type1diabetes
• Interventions: Drug: Glargine; Drug: Degludec; Drug: NPH insulin

• Registration Number: NCT04664764
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Toddlers and preschool children with T1D on insulin therapy

Read More

Exclusion Criteria

• patients with other medical conditions (i.e. celiac disease or autoimmune thyroiditis), patients with other types of diabetes mellitus (i.e. maturity onset diabetes of youth (MODY) and type 2 diabetes mellitus), patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes, renal impairment due to cause other than diabetes, hypertension, patients taking any vitamins or food supplements one month before study and participation in a previous investigational drug study within 3 months preceding screening.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glargine arm	Glargine	group B received insulin glargine
degludec arm	Degludec	Group A received insulin degludec,
NPH group	NPH insulin	Group C received NPH insulin

Primary Outcome Measures

Name	Time	Method
to compare the effectiveness of insulin degludec to insulin glargine and NPH	6 months	to compare the effectiveness of insulin degludec in the form of HBA1C and frequency of hypoglycemia to insulin glargine and NPH in toddlers and preschool children with T1D in terms of HbA1C, IDD and frequency of hypoglycemic episodes.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt