Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182026
Recruitment Status : Unknown
Verified February 2009 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : October 8, 2010
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

September 9, 2005
September 16, 2005
October 8, 2010
June 2005
December 2009   (Final data collection date for primary outcome measure)
A1c [ Time Frame: 6 months and 1 year ]
A1c (6 months & 1 year)
Complete list of historical versions of study NCT00182026 on Archive Site
  • diabetes-related self-care behaviours, drug use, clinical outcomes [ Time Frame: 6 months and 1 year ]
  • diabetes-specific quality of life [ Time Frame: 1 year ]
  • incremental cost/quality-adjusted life-year [QALY] [ Time Frame: 6 months and 1 year ]
  • - diabetes-related self-care behaviours, drug use, clinical outcomes (6 months & 1 year)
  • - diabetes-specific quality of life (1 year)
  • - incremental cost/QALY (6 months & 1 year)
Not Provided
Not Provided
Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
The purpose of this study is to test whether providing personalized diabetes self-management recommendations and feedback improves blood sugar control more than providing generalized diabetes educational material alone.

Diabetes mellitus (DM) is a common chronic disease that is rapidly rising in prevalence, affecting upwards of 35,000 adults in the Hamilton, Ontario region (population 400,000). The magnitude and growth of the problem and its serious health consequences suggest that:

  1. diabetes is now a major public health problem; and
  2. interventions at the community level are needed to mitigate its health impact.

During the last 5 years, Diabetes Hamilton was successfully piloted as a free community-based program available to anyone with diabetes. It promotes diabetes self-management, self-efficacy and awareness through the provision of generalized diabetes information (e.g. newsletters, workshops, forums, resource directories) to consumers, local physicians and other health professionals.

This trial will determine if supplementing Diabetes Hamilton with an automated tailored feedback system that:

  1. provides information;
  2. generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
  3. copies this communication to the patient's designated physician;
  4. facilitates access to community resources; and
  5. provides a simple way for the patient to track changes in indicators of health can improve A1c and other diabetes care indicators more than Diabetes Hamilton alone.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Behavioral: personal feedback report
A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.
Not Provided
Sherifali D, Greb JL, Amirthavasar G, Hunt D, Haynes RB, Harper W, Holbrook A, Capes S, Goeree R, O'Reilly D, Pullenayegum E, Gerstein HC. Effect of computer-generated tailored feedback on glycemic control in people with diabetes in the community: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1794-8. doi: 10.2337/dc11-0006. Epub 2011 Jun 16.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes of 1 or more years duration
  • Health insurance coverage within Ontario
  • Ages 40 or older
  • Registered in, or willing to register in Diabetes Hamilton
  • Able to read and understand English and provide informed consent in English
  • Have home access to either mail, e-mail or the internet
  • Have a baseline A1c >= 7%

Exclusion Criteria:

  • Current pregnancy
  • Residence in an institution that provides diabetes care
  • Cohabiting with study participant
  • Residence outside the city of Hamilton
  • Inability to read or understand English
  • Inability/unwillingness to sign the informed consent or comply with protocol
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hertzel Gerstein, Professor, McMaster University
McMaster University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Hertzel C Gerstein, MD MSc FRCPC McMaster University
McMaster University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP