Diabetes Mellitus, Type 2Phase 4NCT00006163
Computer-assisted Diabetes Self-management Interventions
A Phase 4 study testing Personalized Self-management and Community Resources in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. It evaluates the effectiveness of Personalized Self-Management Training and Community Resources support, using a randomized design. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Personalized Self-management and Community Resources
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Jun 1999
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Diagnosed for at least one year
- Patient of a primary care provider
Who cannot join
- No telephone
- Not speaking English
Trial locations and contacts
1 site in 1 country.
About this study
This project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. It evaluates the effectiveness of Personalized Self-Management Training and Community Resources support, using a randomized design. This study will also evaluate what percent of patients are willing to participate in such a program, and what percent of primary care physicians are willing to recommend it to their patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Personalized Self-management, Community Resources
- Keywords
- diabetes, self-management, randomized trial, RE-AIM evaluation, participation, maintenance, community resources, dietary change
- 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.
Personalized Self-managementBehavioural
Community ResourcesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startSep 1997
- Study completionJun 1999
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 4
- Allocation
- Randomised
- Intervention model
- Factorial
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006163
- Sponsor's protocol ID
- glasgowr (completed)
- Other IDs
- 35524
- Status last verified
- Mar 2010
- First submitted
- 8 Aug 2000
- Last updated
- 2 Mar 2010
- Results posted
- No
Publications
Glasgow RE, La Chance PA, Toobert DJ, Brown J, Hampson SE, Riddle MC. Long-term effects and costs of brief behavioural dietary intervention for patients with diabetes delivered from the medical office. Patient Educ Couns. 1997 Nov;32(3):175-84. doi: 10.1016/s0738-3991(97)00039-6.
PubMed 9423499
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Diabetes Self-management Interventions
- ClinicalTrials.gov ID
- NCT00006163
- Acronym / sponsor ID
- glasgowr (completed)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, self-management, randomized trial, RE-AIM evaluation, participation, maintenance, community resources, dietary change
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 1997
- Study completion
- Jun 1999
- First posted
- 9 Aug 2000 (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.
This project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. It evaluates the effectiveness of Personalized Self-Management Training and Community Resources support, using a randomized design. This study will also evaluate what percent of patients are willing to participate in such a program, and what percent of primary care physicians are willing to recommend it to their patients.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Diagnosed for at least one year
- Patient of a primary care provider
Key exclusion criteria (2 listed)
- No telephone
- Not speaking 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 |
|---|---|---|
| Personalized Self-management | Behavioural | – |
| Community Resources | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Background: PubMed 9423499Glasgow RE, La Chance PA, Toobert DJ, Brown J, Hampson SE, Riddle MC. Long-term effects and costs of brief behavioural dietary intervention for patients with diabetes delivered from the medical office. Patient Educ Couns. 1997 Nov;32(3):175-84. doi: 10.1016/s0738-3991(97)00039-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Personalized Self-management and Community Resources in people with Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Mar 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006163, 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 2 Mar 2010.