NCT00146484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 1996

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1996

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

September 7, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1ChildAdolescentDisease ManagementNewly DiagnosedHemoglobin A, Glycosylated

Outcome Measures

Primary Outcomes (1)

  • * Hemoglobin A1c over the first 24 months of diabetes

Secondary Outcomes (5)

  • * 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

Interventions

Twice Daily versus Three Times Daily Insulin InjectionsDRUG

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Margaret L Lawson, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

April 1, 1996

Study Completion

January 1, 2001

Last Updated

September 7, 2005

Record last verified: 2005-09

Locations

CA(1)