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

NCT ID: NCT00522210

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-03-31

Brief 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).

Detailed Description

Children with type 1 diabetes (DM1) can only be treated with subcutaneous insulin at the present time in Canada. It has been shown that intensive insulin treatment using at least three times daily (TID) insulin injections achieves superior blood glucose control with less long term complications of diabetes than conventional insulin treatment using once daily (OD) or twice daily (BID) insulin injections. However, many patients find it difficult to adhere to TID insulin injections since it is an invasive and painful therapy, which results in frequent insulin omission.

This study is a randomized controlled open-labeled non-inferiority trial to compare the glycemic control as measured by HbA1c after 6 months of a BID insulin regimen using detemir insulin, or the currently used TID insulin with intermediate acting insulin (Novolin NPH or Humulin N). Patients will be randomized to either the active control group (standard TID regimen) or the treatment group (BID regimen with new long acting insulin analogue). A run-in period of 1 month will be used to facilitate the change in insulin regimen. Insulin doses will be adjusted by weekly phone contact with the research nurse for one month prior to baseline blood work. Patients will continue on the same diet and exercise routine as recommended by their usual diabetes team. They will also be seen every 3 months by the research nurse to review blood glucose, assess height and weight and arrange for blood work to be done in conjunction with their routine bloodwork. All patients will continue to be seen by their usual diabetologist, nurse, and dietician at their regularly scheduled clinic visits (every 3 months).

Outcomes include: HA1c between groups at 6 months (surrogate marker of metabolic control for diabetes measured through a venous or capillary blood sample), frequency of adverse events (severe hypoglycemia, mild hypoglycemia, episodes of diabetic ketoacidosis, weight gain), diabetes quality of life for youth (DQOL).

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BID insulin with LA analogue

Treatment Group: BID Insulin Regimen with Long Acting Insulin Analogue (Detemir)

Group Type: EXPERIMENTAL

Detemir

Intervention Type: DRUG

Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time. The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection. The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir. Doses of rapid acting insulin will remain the same at breakfast and at supper.

Standard TID insulin

Active Control Group: Usual TID Insulin Regimen (intermediate insulin- Humulin N or Novolin NPH)

Group Type: ACTIVE_COMPARATOR

Novolin NPH or Humulin N

Intervention Type: OTHER

Patients will continue on their usual insulin regimen of insulin three times per day. Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.

Interventions

Detemir

Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time. The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection. The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir. Doses of rapid acting insulin will remain the same at breakfast and at supper.

Intervention Type: DRUG

Novolin NPH or Humulin N

Patients will continue on their usual insulin regimen of insulin three times per day. Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.

Intervention Type: OTHER

Other Intervention Names

Levemir

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Josephine Ho

Pediatric Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josephine Ho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

References

Ho J, Huang C, Nettel-Aguirre A, Pacaud D. Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial. Int J Pediatr Endocrinol. 2011 Nov 8;2011(1):15. doi: 10.1186/1687-9856-2011-15.

Reference Type: RESULT

PMID: 22067102 (View on PubMed)

Other Identifiers

E-20635

Identifier Type: -

Identifier Source: org_study_id