Type 2 DiabetesNCT04970810
My Diabetes, My Community
A study testing My Diabetes Goal and My Diabetes Goal + CommunityRx in people with Type 2 Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- My Diabetes Goal and My Diabetes Goal + CommunityRx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of type 2 diabetes
- Seen in clinic within past year
- A1C>7.5%
- Community dwelling
- Access to personal email address OR internet access
- Speaks and reads English
- Resides in the target geographic region (zip codes)
Who cannot join
- Unable to consent to study for themselves
- Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.
Read the detailed description
To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) <7.5%, <8.0%, or <8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources.
Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.
- Conditions
- Type 2 Diabetes
- Being tested
- My Diabetes Goal, My Diabetes Goal + CommunityRx
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Diabetes GoalBehavioural
Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
My Diabetes Goal + CommunityRxBehavioural
Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | No intervention | Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) |
| My Diabetes Goal | Active comparator | My Diabetes Goal protocol Receives: Behavioral: My Diabetes Goal |
| My Diabetes Goal + Community Rx | Active comparator | My Diabetes Goal protocol + Community Rx protocol Receives: Behavioral: My Diabetes Goal + CommunityRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Percent of Hemoglobin A1C
Mean change in percent of hemoglobin A1C from baseline to month 12.
Measured: Baseline to 12 months
Secondary outcomes (4)
Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12
We reviewed the electronic health records (EHR) to assess how many participants had a documented goal in the EHR at baseline and at 12 months. The possible values will be yes or no goals documented in the EHR.
Measured: Baseline to 12 months
Personalized A1C Goals
The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. Goal setting conversation with nurse occurred during Month 1 call.
Measured: Baseline to Month 1 Call
Number of Participants Who Achieved Personalized A1C Goals
Investigators will measure whether or not patients are reaching the modified goals they have documented in the survey, among those who have set up their personalized goals. The possible values will be yes or no reaching personalized goals.
Measured: Baseline to 12 months
Diabetes Empowerment Scale (DES)
Evaluate subject self-efficacy through the Diabetes Empowerment Scale (DES). DES is a standardized questionnaire including 28 questions with response categories of 'strongly disagree', 'somewhat disagree', 'neutral', 'somewhat agree', and 'strongly agree'. A total score for the DES is calculated by summing all of the item scores and dividing by 28 for a possible score range of 1-5 where a higher score indicates a higher level of empowerment.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start29 Jul 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elbert Huang, Principal investigator, University of ChicagoStacy Lindau, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970810
- Sponsor's protocol ID
- IRB20-0870
- Other IDs
- 1R01DK127961-01
- Status last verified
- Oct 2025
- First submitted
- 18 May 2020
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD with other researchers.
Publications
Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.
PubMed 36909590
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Diabetes, My Community
- ClinicalTrials.gov ID
- NCT04970810
- Acronym / sponsor ID
- IRB20-0870
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.
Detailed description
To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) <7.5%, <8.0%, or <8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources.
Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attention Control | No intervention | –Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control) |
| My Diabetes Goal | Active comparator | Behavioral: My Diabetes GoalMy Diabetes Goal protocol |
| My Diabetes Goal + Community Rx | Active comparator | Behavioral: My Diabetes Goal + CommunityRxMy Diabetes Goal protocol + Community Rx protocol |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of type 2 diabetes
- Seen in clinic within past year
- A1C>7.5%
- Community dwelling
- Access to personal email address OR internet access
Key exclusion criteria (2 listed)
- Unable to consent to study for themselves
- Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials
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 |
|---|---|---|
| My Diabetes GoalSubjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. | Behavioural | My Diabetes Goal |
| My Diabetes Goal + CommunityRxSubjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations. | Behavioural | My Diabetes Goal + Community Rx |
Primary outcome
Mean Change in Percent of Hemoglobin A1C
Time frame: Baseline to 12 months
Mean change in percent of hemoglobin A1C from baseline to month 12.
4 secondary outcomes
Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12
Time frame: Baseline to 12 months
Personalized A1C Goals
Time frame: Baseline to Month 1 Call
Number of Participants Who Achieved Personalized A1C Goals
Time frame: Baseline to 12 months
Diabetes Empowerment Scale (DES)
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36909590Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers.
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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.
Elbert Huang principal investigator
University of Chicago
Stacy Lindau principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Diabetes Goal and My Diabetes Goal + CommunityRx in people with Type 2 Diabetes, run by University of Chicago 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 7 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 17 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Percent of Hemoglobin A1C (time frame: Baseline to 12 months). 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 NCT04970810, 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 17 Dec 2025.