Diabetes Mellitus, Type 2NCT05571436
iCan Diabetes Self-management and Prevention Program
A study testing iCan Diabetes Self-management and Prevention Support Group in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and preliminary efficacy of the iCan Diabetes Self-Management and Prevention Support Group using a single arm clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- iCan Diabetes Self-management and Prevention Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 30 Aug 2023
- 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
- Adult aged 18 years or older
- Have been diagnosed with type 2 diabetes or prediabetes
- Can read, write, and speak in English
Who cannot join
- Attended a diabetes self-management program or diabetes prevention program within the last 3 months
- Plan to attend another diabetes self-management program or diabetes prevention program within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267
Seung-Yeon Lee, PhD, 513-558-7508, lee2so@ucmail.uc.edu
About this study
Official title: iCan Diabetes Self-Management and Prevention Support Group
The purpose of this study is to test the feasibility and preliminary efficacy of the iCan Diabetes Self-Management and Prevention Support Group using a single arm clinical trial. The program is composed of six weekly sessions, and it will be implemented with 60 adults (aged 18 years or older) who have been diagnosed with type 2 diabetes or prediabetes and evaluated using mixed methods. A pre-test will be conducted before the program implementation and a post-test will be conducted three months after the pre-test. Focus groups will be conducted shortly after the last session to obtain feedback on the program. Between the last session and the post-test, weekly emails/texts will be sent to keep participants engaged and maximize retention rate.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Being tested
- iCan Diabetes Self-management and Prevention Support Group
- Keywords
- Diabetes Mellitus, Type 2, Prediabetes, Self-management
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCan Diabetes Self-management and Prevention Support GroupBehavioural
Participants will be asked to attend six weekly sessions and complete pre-and post-assessments with an optional focus group.
The intervention will cover the following topics: 1) Yes, iCan! - Affirmations and Empowerment, 2) The Language of Diabetes - Diabetes Synopsis, 3) Diabetes and Me - Management Strategies, 4) Extraordinary Health - Dream Team, 5) Food for Thought - Food Conscious, and 6) Discussion - Stories/Goals.
Each session is composed of a Check-in, Affirmation/Empowerment Activity, Short Presentation, Q\&A and Discussion, Goal setting, and Testing Healthy Snacks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | iCan Diabetes Self-Management and Prevention Program Receives: Behavioral: iCan Diabetes Self-management and Prevention Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (A1C)
Glycemic control
Measured: 3 months
Diabetes self-management behavior
Diabetes Self-Management Questionnaire (DSMQ) (16 items)
Measured: 3 months
Secondary outcomes (1)
Self-efficacy related to diabetes self-management
Diabetes Empowerment Scale (28 items)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start17 Oct 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Yeon Lee, University of Cincinnati
- Investigators
- Seung-Yeon Lee, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571436
- Sponsor's protocol ID
- 2022-0532
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCan Diabetes Self-Management and Prevention Support Group
- ClinicalTrials.gov ID
- NCT05571436
- Acronym / sponsor ID
- 2022-0532
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Keywords
- Diabetes Mellitus, Type 2, Prediabetes, Self-management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 17 Oct 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 7 Oct 2022 (actual)
- 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 the feasibility and preliminary efficacy of the iCan Diabetes Self-Management and Prevention Support Group using a single arm clinical trial. The program is composed of six weekly sessions, and it will be implemented with 60 adults (aged 18 years or older) who have been diagnosed with type 2 diabetes or prediabetes and evaluated using mixed methods. A pre-test will be conducted before the program implementation and a post-test will be conducted three months after the pre-test. Focus groups will be conducted shortly after the last session to obtain feedback on the program. Between the last session and the post-test, weekly emails/texts will be sent to keep participants engaged and maximize retention rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: iCan Diabetes Self-management and Prevention Support GroupiCan Diabetes Self-Management and Prevention Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult aged 18 years or older
- Have been diagnosed with type 2 diabetes or prediabetes
- Can read, write, and speak in English
Key exclusion criteria (2 listed)
- Attended a diabetes self-management program or diabetes prevention program within the last 3 months
- Plan to attend another diabetes self-management program or diabetes prevention program within 3 months
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 |
|---|---|---|
| iCan Diabetes Self-management and Prevention Support GroupParticipants will be asked to attend six weekly sessions and complete pre-and post-assessments with an optional focus group. The intervention will cover the following topics: 1) Yes, iCan! - Affirmations and Empowerment, 2) The Language of Diabetes - Diabetes Synopsis, 3) Diabetes and Me - Management Strategies, 4) Extraordinary Health - Dream Team, 5) Food for Thought - Food Conscious, and 6) Discussion - Stories/Goals. Each session is composed of a Check-in, Affirmation/Empowerment Activity, Short Presentation, Q\&A and Discussion, Goal setting, and Testing Healthy Snacks. | Behavioural | Intervention group |
Primary outcome
Hemoglobin A1c (A1C)
Time frame: 3 months
Glycemic control
Diabetes self-management behavior
Time frame: 3 months
Diabetes Self-Management Questionnaire (DSMQ) (16 items)
1 secondary outcome
Self-efficacy related to diabetes self-management
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
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.
Seung-Yeon Lee, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCan Diabetes Self-management and Prevention Support Group in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by University of Cincinnati 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Yeon Lee, PhD (513-558-7508, lee2so@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (A1C) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2022.