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

Children's Hospital of Eastern Ontario

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Twice Daily versus Three Times Daily Insulin Injections

Study type

Interventional

Funder types

Other

Identifiers

NCT00146484

CHEO RI cc9993

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 17 years old

Volunteers

No 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).