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

NCT ID: NCT00146484

Last Updated: 2005-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-04-30

Study Completion Date

2001-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Keywords

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Newly Diagnosed Hemoglobin A, Glycosylated Diabetes Mellitus, Type 1 Child Adolescent Disease Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Twice Daily versus Three Times Daily Insulin Injections

Intervention Type DRUG

Eligibility Criteria

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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).
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Eastern Ontario

OTHER

Sponsor Role lead

Principal Investigators

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Margaret L Lawson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

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Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CHEO RI cc9993

Identifier Type: -

Identifier Source: org_study_id