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Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

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ClinicalTrials.gov Identifier: NCT04664764
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Nouran yousef, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus With Hypoglycemia type1diabetes Drug: Degludec Drug: Glargine Drug: NPH insulin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664764


Contacts
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Contact: eman sakr +20206603336 niron85@hotmail.com

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt, 11375
Contact: Safinaz ElHabashi    01116603336    safinazelhabashy@med.asu.edu.eg   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Safinaz El Habashy Ain Shams University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Nouran yousef, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT04664764    
Other Study ID Numbers: Basal insulin toddlers
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available upon request

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs