DiabetesNCT03046498
Addressing Diabetes Together
A study testing Evidence-Based Program in people with Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Evidence-Based Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 1 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Diagnosis of diabetes
- enrolled in the DSMP or DPP
Who cannot join
- unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Diabetes Together: Implementation of a Regional Partnership for Population Health Management in Southeast Minnesota
Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.
- Conditions
- Diabetes
- Being tested
- Evidence-Based Program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based ProgramBehavioural
DSMP and DPP
| Study group | Role | What they receive |
|---|---|---|
| Program participants | Experimental | Patients enrolled in the DSMP and DPP who provide consent. Receives: Behavioral: Evidence-Based Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in number of program offerings implemented in the community
Measured: Change from Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start2 Feb 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron L. Leppin, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046498
- Sponsor's protocol ID
- 16-008948
- Status last verified
- May 2018
- First submitted
- 2 Feb 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leppin AL, Okamoto JM, Organick PW, Thota AD, Barrera-Flores FJ, Wieland ML, McCoy RG, Bonacci RP, Montori VM. Applying Social Network Analysis to Evaluate Implementation of a Multisector Population Health Collaborative That Uses a Bridging Hub Organization. Front Public Health. 2018 Nov 2;6:315. doi: 10.3389/fpubh.2018.00315. eCollection 2018.
PubMed 30450355
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Diabetes Together: Implementation of a Regional Partnership for Population Health Management in Southeast Minnesota
- ClinicalTrials.gov ID
- NCT03046498
- Acronym / sponsor ID
- 16-008948
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 8 Feb 2017 (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.
Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Program participants | Experimental | Behavioral: Evidence-Based ProgramPatients enrolled in the DSMP and DPP who provide consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years or older
- Diagnosis of diabetes
- enrolled in the DSMP or DPP
Key exclusion criteria (1 listed)
- unable to provide consent
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 |
|---|---|---|
| Evidence-Based ProgramDSMP and DPP | Behavioural | Program participants |
Primary outcome
Measure change in number of program offerings implemented in the community
Time frame: Change from Baseline to 1 year
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 14 May 2018.
- Derived from this study: PubMed 30450355Leppin AL, Okamoto JM, Organick PW, Thota AD, Barrera-Flores FJ, Wieland ML, McCoy RG, Bonacci RP, Montori VM. Applying Social Network Analysis to Evaluate Implementation of a Multisector Population Health Collaborative That Uses a Bridging Hub Organization. Front Public Health. 2018 Nov 2;6:315. doi: 10.3389/fpubh.2018.00315. eCollection 2018.
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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 study testing Evidence-Based Program in people with Diabetes, run by Mayo Clinic 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 1 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 14 May 2018. 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.
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.
What does the primary outcome measure?
Measure change in number of program offerings implemented in the community (time frame: Change from Baseline to 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 NCT03046498, 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 14 May 2018.