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

Sponsor

Children's Hospital of Eastern Ontario (Other)

Overall Status

Completed

CT.gov ID

NCT00146484

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Apr 1, 1996

Study Completion Date :

Jan 1, 2001

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).