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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146484
• Other study ID #: CHEO RI cc9993
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: April 1996
• Est. completion date: January 2001

Study information

• Verified date: September 2005
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Twice Daily versus Three Times Daily Insulin Injections

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	* Hemoglobin A1c over the first 24 months of diabetes
Secondary	* Frequency of hypoglycemia (mild and severe) over the first 24 months of diabetes
Secondary	* Frequency of morning hyperglycemia over the first 24 months of diabetes
Secondary	* Residual c-peptide at two years post diagnosis (stimulated c-peptide post Sustacal challenge)
Secondary	* Diabetes Quality of Life (DQOLY) over the first 24 months of diabetes
Secondary	* Family Functioning (Family Environment Scale)over the first 24 months of diabetes