Diabetes Mellitus, Type 2NCT00182026
Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
A study testing personal feedback report in people with Diabetes Mellitus, Type 2, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- personal feedback report
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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:
- diabetes is now a major public health problem; and
- 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:
- provides information;
- generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
- copies this communication to the patient's designated physician;
- facilitates access to community resources; and
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- personal feedback report
- Keywords
- diabetes, community intervention, self-management, prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personal feedback reportBehavioural
A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
Measured: 6 months and 1 year
Secondary outcomes (3)
diabetes-related self-care behaviours, drug use, clinical outcomes
Measured: 6 months and 1 year
diabetes-specific quality of life
Measured: 1 year
incremental cost/quality-adjusted life-year [QALY]
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Hertzel C Gerstein, MD MSc FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182026
- Sponsor's protocol ID
- MCT-68786
- Status last verified
- Feb 2009
- First submitted
- 9 Sep 2005
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21680723
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
- ClinicalTrials.gov ID
- NCT00182026
- Acronym / sponsor ID
- MCT-68786
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, community intervention, self-management, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- diabetes is now a major public health problem; and
- 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:
- provides information;
- generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
- copies this communication to the patient's designated physician;
- facilitates access to community resources; and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personal feedback reportA computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire. | Behavioural | – |
Primary outcome
A1c
Time frame: 6 months and 1 year
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
- Derived from this study: PubMed 21680723Sherifali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hertzel C Gerstein, MD MSc FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personal feedback report in people with Diabetes Mellitus, Type 2, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1c (time frame: 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2010.