Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus With Hypoglycemia, type1diabetes

Intervention / Treatment
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* Drug: Degludec
* Drug: Glargine
* Drug: NPH insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: degludec arm<br>Group A received insulin degludec, | Drug: Degludec<br>* Basal insulin comparison<br>|
| Active Comparator: glargine arm<br>group B received insulin glargine | Drug: Glargine<br>* Basal insulin comparison<br>|
| Active Comparator: NPH group<br>Group C received NPH insulin | Drug: NPH insulin<br>* Basal insulin comparison<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |