Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2021-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

NCT01513473

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE3

Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes

NCT01840358

Type 1 Diabetes

UNKNOWN NA

Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump

NCT03882463

Diabetes Mellitus, Type 1

COMPLETED NA

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

NCT02411578

Diabetes Mellitus, Type 1

COMPLETED PHASE2

Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes

NCT04614168

Type 1 Diabetes Type 1 Diabetes Mellitus With Hypoglycemia Hypoglycemia +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus With Hypoglycemia type1diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

degludec arm

Group A received insulin degludec,

Group Type ACTIVE_COMPARATOR

Degludec

Intervention Type DRUG

Basal insulin comparison

glargine arm

group B received insulin glargine

Group Type ACTIVE_COMPARATOR

Glargine

Intervention Type DRUG

Basal insulin comparison

NPH group

Group C received NPH insulin

Group Type ACTIVE_COMPARATOR

NPH insulin

Intervention Type DRUG

Basal insulin comparison

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Degludec

Basal insulin comparison

Intervention Type DRUG

Glargine

Basal insulin comparison

Intervention Type DRUG

NPH insulin

Basal insulin comparison

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No