Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2005
Date assigned
10/08/2005
Last edited
26/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hertzel C Gerstein

ORCID ID

Contact details

McMaster University
1200 Main Street West
Room 3V38
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 521 2100 ext. 73371
gerstein@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00182026

Protocol/serial number

MCT-68786

Study information

Scientific title

A randomised trial of diabetes intervention in the community to help achieve reduced glucose elevation: Diabetes IN-CHARGE

Acronym

Diabetes IN-CHARGE

Study hypothesis

This trial will determine if supplementing a community-based diabetes program with an automated system that generates specific evidence-based tailored recommendations to individuals/MDs based on responses to a self-administered questionnaire lowers hemoglobin A1c levels (A1c) more than the community-based program (i.e. Diabetes Hamilton) alone.

As of 15/01/2008, this record was updated to include an extended anticipated end date due to recruitment taking longer than anticipated; the initial end date at the time of registration was 31/07/2007 was updated to 30/06/2009.

As of 26/02/2009 this record was updated to include another extension to the anticipated end date to allow for completion of all follow-ups. The previous end date was 30/06/2009 and this has now been updated to 31/12/2009.

Ethics approval

McMaster University Research Ethics Board gave approval on the 31st August 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Participants in the community with type 2 diabetes will be enrolled in Diabetes Hamilton, fill out a questionnaire, and have regular information regarding diabetes management sent to them and their MD. Allocation will be to either receive or not receive automated recommendations and reminders based on the questionnaire response, interpretation of their HbA1c, a customised list of resources, and simple tools to track glucose control, HbA1c and related variables.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HbA1c Levels

Secondary outcome measures

1. Self-care behaviours
2. Drug use (i.e. angiotensin-converting enzyme [ACE]-inhibitor, cholesterol-lowering
aspirin, angiotensin 2 receptor blocker, beta blocker, diuretic, influenza immunisation)
3. Clinical outcomes
4. Hospitalisations
5. Quality of life
6. Incremental cost per quality-adjusted life-year (QALY)

Overall trial start date

01/04/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

500 participants with type two diabetes, both sex, 30 years and older
1. Type 2 diabetes of 1 or more years duration
2. Ontario Health Insurance Plan (OHIP) coverage
3. Registered in, or willingness to register in Diabetes Hamilton
4. English fluency
5. Provide consent
6. Have home access to either mail, email or the internet
7. Have a baseline HbA1c level greater than 7%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Current pregnancy
2. Institutionalised
3. Cohabiting first degree relative of a participant in the study
4. Inability to read or understand English
5. Inability or unwillingness to consent or comply with the protocol
6. Residence outside the city of Hamilton

Recruitment start date

01/04/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Canada

Trial participating centre

McMaster University
Hamilton, Ontario
L8N 3Z5
Canada

Sponsor information

Organisation

McMaster University Health Sciences Centre (Canada)

Sponsor details

1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada

Sponsor type

University/education

Website

http://fhs.mcmaster.ca/main/index.html

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68786)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes