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Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

NCT04664764 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-02-16

No results posted yet for this study

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

DRUG

Degludec

Basal insulin comparison

DRUG

Glargine

Basal insulin comparison

DRUG

NPH insulin

Basal insulin comparison

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Safinaz El Habashy · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2021-02-28
Completion
2021-03-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664764 on ClinicalTrials.gov