A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00146484
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Twice Daily versus Three Times Daily Insulin Injections
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • * Hemoglobin A1c over the first 24 months of diabetes

Secondary Outcome Measures:
  • * Frequency of hypoglycemia (mild and severe) over the first 24 months of diabetes
  • * Frequency of morning hyperglycemia over the first 24 months of diabetes
  • * Residual c-peptide at two years post diagnosis (stimulated c-peptide post Sustacal challenge)
  • * Diabetes Quality of Life (DQOLY) over the first 24 months of diabetes
  • * Family Functioning (Family Environment Scale)over the first 24 months of diabetes

Estimated Enrollment: 100
Study Start Date: April 1996
Estimated Study Completion Date: January 2001
Detailed Description:

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a “honeymoon” period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New onset type 1 diabetes
  • Less than 48 hours since first insulin injection
  • Child and/or parent able to read and write English
  • Family intends to continue treatment at our institution for the next two years
  • Informed consent from adolescents greater than 16 years of age, or if less than 16 years, informed consent from the parent/guardian with assent from the child.

Exclusion Criteria:

  • Chronic medical conditions other than treated hypothyroidism or mild asthma
  • Concerns of the diabetes team regarding future treatment adherence making twice daily insulin preferable to the split evening injection regimen (e.g., cognitive impairment, severe family dysfunction).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146484

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Margaret L Lawson, MD Children's Hospital of Eastern Ontario
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00146484     History of Changes
Other Study ID Numbers: CHEO RI cc9993
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:
Diabetes Mellitus, Type 1
Child
Adolescent
Disease Management
Newly Diagnosed
Hemoglobin A, Glycosylated

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014