Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: type1diabetes; Type 1 Diabetes Mellitus With Hypoglycemia

Treatments: Drug: Glargine; Drug: Degludec; Drug: NPH insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04664764

Basal insulin toddlers

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

degludec arm

Active Comparator group

Description:

Group A received insulin degludec,

Treatment:

Drug: Degludec

glargine arm

Active Comparator group

Description:

group B received insulin glargine

Treatment:

Drug: Glargine

NPH group

Active Comparator group

Description:

Group C received NPH insulin

Treatment:

Drug: NPH insulin