Diabetes Mellitus, Type 2NCT03692208
Managing Diabetes to Gain Opportunities for a More Active Life
A study testing My Diabetes Goal Survey and Optional Care Management in people with Diabetes Mellitus, Type 2, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- My Diabetes Goal Survey and Optional Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 29 Sep 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older
- Diagnosis of Type 2 Diabetes
- Enrolled in MyChart (University of Chicago Patient Portal)
- Outpatient clinic visit in the prior year
Who cannot join
- Under 64 years of age
- No type 2 diabetes
- Not enrolled in MyChart
- No outpatient clinic visit in the prior year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)
The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.
Read the detailed description
The purpose of this novel patient-facing disease management intervention, My Diabetes GOAL, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources). This application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- My Diabetes Goal Survey and Optional Care Management
- Keywords
- Geriatrics
- 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 Goal Survey and Optional Care ManagementBehavioural
The intervention is already described in the intervention arm description.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart. Receives: Behavioral: My Diabetes Goal Survey and Optional Care Management |
| Delayed Intervention/Control | Active comparator | Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above. Receives: Behavioral: My Diabetes Goal Survey and Optional Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of Diabetes Goal
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
Measured: Baseline, 6 months
Secondary outcomes (2)
Personalized A1C Goals
The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. The number of analyzed A1C goal results is therefore dependent on the number of survey respondents.
Measured: Baseline, 6 months
Patient Ability to Reach Personalized Goals
Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey.
Measured: Baseline, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start29 Oct 2018
- Primary completion12 Aug 2020
- Study completion29 Sep 2020
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 Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Elbert S Huang, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692208
- Sponsor's protocol ID
- IRB18-0425
- Other IDs
- R01DK127961-01
- Status last verified
- Jan 2023
- First submitted
- 20 Sep 2018
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu M, Cui M, Nathan AG, Press VG, Wan W, Miles C, Ali R, Pusinelli M, Huisingh-Scheetz M, Huang ES. A nurse driven care management program to engage older diabetes patients in personalized goal setting and disease management. Health Sci Rep. 2024 Jun 23;7(6):e2208. doi: 10.1002/hsr2.2208. eCollection 2024 Jun.
PubMed 38915356
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)
- ClinicalTrials.gov ID
- NCT03692208
- Acronym / sponsor ID
- IRB18-0425
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 21 Feb 2023
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 novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.
Detailed description
The purpose of this novel patient-facing disease management intervention, My Diabetes GOAL, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources). This application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: My Diabetes Goal Survey and Optional Care ManagementPatients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart. |
| Delayed Intervention/Control | Active comparator | Behavioral: My Diabetes Goal Survey and Optional Care ManagementPatients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years and older
- Diagnosis of Type 2 Diabetes
- Enrolled in MyChart (University of Chicago Patient Portal)
- Outpatient clinic visit in the prior year
Key exclusion criteria (4 listed)
- Under 64 years of age
- No type 2 diabetes
- Not enrolled in MyChart
- No outpatient clinic visit in the prior year
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 Goal Survey and Optional Care ManagementThe intervention is already described in the intervention arm description. | Behavioural | Delayed Intervention/Control, Intervention |
Primary outcome
Documentation of Diabetes Goal
Time frame: Baseline, 6 months
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
2 secondary outcomes
Personalized A1C Goals
Time frame: Baseline, 6 months
Patient Ability to Reach Personalized Goals
Time frame: Baseline, 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38915356Zhu M, Cui M, Nathan AG, Press VG, Wan W, Miles C, Ali R, Pusinelli M, Huisingh-Scheetz M, Huang ES. A nurse driven care management program to engage older diabetes patients in personalized goal setting and disease management. Health Sci Rep. 2024 Jun 23;7(6):e2208. doi: 10.1002/hsr2.2208. eCollection 2024 Jun.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 S Huang, MD 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 Survey and Optional Care Management in people with Diabetes Mellitus, Type 2, 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 4 inclusion and 4 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 21 Feb 2023. 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 21 Feb 2023). 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?
Documentation of Diabetes Goal (time frame: Baseline, 6 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 NCT03692208, 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 21 Feb 2023.