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

August 29, 2014 updated by: Josephine Ho, University of Calgary

A Comparison of Insulin Detemir in a BID Insulin Regimen Versus a TID Insulin Regimen in Children With Type 1 Diabetes: A Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

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).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BID insulin with LA analogue
Treatment Group: BID Insulin Regimen with Long Acting Insulin Analogue (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.
Other Names:
  • Levemir
Active Comparator: Standard TID insulin
Active Control Group: Usual TID Insulin Regimen (intermediate insulin- Humulin N or Novolin NPH)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1C
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of episodes of hypoglycemia (severe and mild)
Time Frame: 6 months
6 months
Number of episodes of diabetic ketoacidosis (DKA)
Time Frame: 6 months
6 months
Body Mass Index (BMI) kg/m2
Time Frame: 6 months
6 months
Diabetes Quality of Life Questionaire-youth version
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Josephine Ho, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

March 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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