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
Overview
- Phase
- Phase 4
- Intervention
- Degludec
- Conditions
- Type 1 Diabetes Mellitus With Hypoglycemia
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- to compare the effectiveness of insulin degludec to insulin glargine and NPH
- Last Updated
- 5 years ago
Overview
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.
Investigators
Nouran yousef
Dr
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Toddlers and preschool children with T1D on insulin therapy
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.
Arms & Interventions
degludec arm
Group A received insulin degludec,
Intervention: Degludec
glargine arm
group B received insulin glargine
Intervention: Glargine
NPH group
Group C received NPH insulin
Intervention: NPH insulin
Outcomes
Primary Outcomes
to compare the effectiveness of insulin degludec to insulin glargine and NPH
Time Frame: 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.