Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

February 12, 2021 updated by: Nouran yousef, Ain Shams University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: degludec arm
Group A received insulin degludec,
Drug: Degludec
Basal insulin comparison
ACTIVE_COMPARATOR: glargine arm
group B received insulin glargine
Drug: Glargine
Basal insulin comparison
ACTIVE_COMPARATOR: NPH group
Group C received NPH insulin
Drug: NPH insulin
Basal insulin comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Safinaz El Habashy, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2019

Primary Completion (ANTICIPATED)

February 28, 2021

Study Completion (ANTICIPATED)

March 10, 2021

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Basal insulin toddlers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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