Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

1. Children with DM1 6-17 years old that are currently on a TID regimen of insulin with rapid acting insulin and intermediate acting insulin.

2. Currently being followed at the Alberta Children's Hospital Diabetes Clinic.

3. Duration of diabetes of at least 12 months.

Exclusion Criteria:

1. Children younger than 6 years of age will be excluded since long-acting analogue has not been approved in children younger than 6 years old.

2. Children with compromised metabolic control (HA1c greater than 10%).

3. Children with other chronic underlying medical conditions that could affect glycemic control i.e. uncontrolled hypothyroidism, hyperthyroidism, celiac disease, etc.

4. Language or psychosocial barrier preventing the family from completing the study.

5. Diabetes duration of less than 12 months.

6. Participation in other clinical trials with specified clinic visit schedule.

7. Patients currently on insulin pump therapy or multiple daily injections of greater than three injections per day.