Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

NCT04664764 | Unknown Phase 4

• 1 other identifier: Basal insulin toddlers
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia; type1diabetes

Outcome Measures

Primary Outcomes (1)

• to compare the effectiveness of insulin degludec to insulin glargine and NPH

  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.

  6 months

Study Arms (3)

degludec arm

ACTIVE COMPARATOR

Group A received insulin degludec,

Drug: Degludec

glargine arm

ACTIVE COMPARATOR

group B received insulin glargine

Drug: Glargine

NPH group

ACTIVE COMPARATOR

Group C received NPH insulin

Drug: NPH insulin

Interventions

Degludec DRUG

Basal insulin comparison

degludec arm

Glargine DRUG

Basal insulin comparison

glargine arm

NPH insulin DRUG

Basal insulin comparison

NPH group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Toddlers and preschool children with T1D on insulin therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11375, Egypt

RECRUITING

MeSH Terms

Interventions

insulin degludec; Insulin Glargine; Insulin, Isophane

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Safinaz El Habashy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eman sakr

CONTACT

+20206603336; niron85@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 11, 2020
• Study Start: February 21, 2019
• Primary Completion: February 28, 2021
• Study Completion: March 10, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)