DiabetesCGM ASSISTNCT05643144
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
A study testing Continuous Glucose Monitoring in people with Diabetes and Alzheimer's Disease (Incl Subtypes), run by Indiana University at 1 site in United States.
Trial summary
The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors. Managing diabetes is often difficult for people with memory issues. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia
- What is being tested?
- Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Patient-Caregiver Dyad Inclusion Criteria:
- patient must have dual diagnosis of MCI or ADRD and diabetes (DM)
- patient must have active prescriptions for DM
- patient must have had at least one visit to an Eskenazi or IU Health primary care clinic within 12 months
- patient must be able to provide assent and have a legally authorized representative (LAR) consent on their behalf if patient lacks capacity to consent
- patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient
- patient and caregiver must both speak English
- patient and caregiver must both reside in the community
- dyad must have internet access
Patient-Caregiver Dyad Exclusion Criteria:
- patient has terminal illness
- use of an automated insulin delivery system
- patient is receiving dialysis
- patient is taking ascorbic acid during monitoring period
- patient has existing implanted medical devices
- patient has a bleeding disorder
- patient has a pre-existing arm skin lesions
- patient has an allergy to medical adhesive or isopropyl alcohol
- patient has plans for imaging or diathermy treatment during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eskenazi Health
Indianapolis, Indiana, 46202
Patricia Noblet
About this study
Official title: Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes
The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors.
Managing diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings.
Read more
The study aims to:
- Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it.
- Improve Teamwork: Encourage "shared decision-making," where patients, caregivers, and doctors work together to make health choices.
- Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives.
- Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes.
By using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team.
Participants will:
- Answer a survey about how they manage their diabetes
- Learn how to use a Continuous Glucose Monitor and wear it for 14 days
- Answer 3 brief telephone surveys during these 14 days
- Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report
Read the detailed description
Background and Clinical Significance Over 11 million Americans aged 65 and older live with diabetes mellitus (DM), and an estimated 13-20% of this population also has Alzheimer's disease and related dementias (ADRD). Hypoglycemia is a serious and frequent complication in this population, affecting 10-25% of patients and increasing the risk of coma, macrovascular events, and death.
A harmful cycle exists in ADRD-DM management: cognitive impairment hinders the detection of hypoglycemia and the management of glucose levels, while low glucose levels further impair cognition. Although clinical guidelines recommend de-intensifying medications and simplifying routines to reduce risk, these guidelines are often not implemented in clinical practice.
The Role of Continuous Glucose Monitoring (CGM) Continuous glucose monitoring (CGM) devices are effective tools for detecting hypoglycemia by tracking glucose levels every 5-15 minutes. While CGM has proven feasible in older adults without cognitive impairment, research indicates that standard CGM data reports are often difficult for patients and caregivers to interpret. This lack of interpretability creates a barrier to shared decision-making regarding behavior modifications, glycemic targets, and medication de-intensification.
Study Objective: CGM ASSIST This study aims to address these translational gaps by developing and testing CGM ASSIST. This intervention adapts standard CGM technology by adding interactive information displays (novel companion information guides) designed specifically for the ADRD-DM population and their caregivers.
The study follows a multi-phase approach:
Characterization of Needs: Identifying the unmet needs and decision-making processes of patient-caregiver dyads using CGM.
User-Centered Design: Engaging patients, caregivers, and clinicians in a design process to create the CGM ASSIST interactive reports.
Pilot Testing: Conducting a clinical trial to assess the feasibility, usability, and impact of the CGM ASSIST reports on shared decision-making and individualized care.
The long-term goal of this research is to improve the characterization of decision-making in adults with MCI and ADRD and to provide tools that help families identify and address unmet medical needs through better interpretation of clinical data.
- Conditions
- Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia, Hypoglycemia
- Being tested
- Continuous Glucose Monitoring
- Keywords
- Continuous glucose monitoring, Shared decision-making, Human factors, Primary care
- Medical subject headings
- Diabetes Mellitus, Alzheimer Disease, Dementia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Caregiver Dyads | Experimental | Participants will wear a continuous glucose monitor Receives: Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment
Total number of participants enrolled divided by the total participants screened as eligible.
Measured: 8 months
Feasibility- Retention
Total number of participants who completed the study divided by the total number of participants enrolled in the study.
Measured: 2 months
Feasibility- CGM Device Adherence
This measures data completeness. Total number of days CGM worn and active divided by the total number of days in the observation period.
Measured: 14 days
System Usability Scale
The System Usability Scale (SUS) is a 10-item validated questionnaire used to evaluate the usability of the CGM ASSIST interactive information display. Participants rate each item on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). To calculate the final SUS score, the response for each odd-numbered item is reduced by 1, and the response for each even-numbered item is subtracted from 5. These adjusted scores are then summed and multiplied by 2.5. The total score ranges from 0 to 100. A higher score indicates better usability (e.g., a score above 68 is generally considered above average).
Measured: 2 months
CollaboRATE Questionnaire
The CollaboRATE questionnaire is a 3-item validated patient-reported measure used to assess the level of shared decision-making during clinical encounters. The three items focus on how much effort was made: 1) to help the participant understand their health issues, 2) to listen to what matters most to the participant, and 3) to include the participant's preferences in the choice of next steps. Each item is scored on a 5-point Likert scale ranging from 1 (No effort was made) to 5 (Every effort was made). For each participant, a total score is calculated by summing the scores of the three items. The total score ranges from 3 to 15. A higher score indicates a higher perceived level of shared decision-making.
Measured: 2 months
Number of Changes in Diabetes Management
This measure tracks the total number of management changes made to a participant's diabetes care plan based on medical record review. A "change" is defined as any of the following: 1) Initiation of new medications or technology, 2) New referrals to specialists or community services, 3) Discontinuation of existing medications, and 4) Modification (increase or decrease) of current medication dosages.
Measured: 12 months
Secondary outcomes (5)
Hypoglycemia - Time Below Range (TBR)
The percentage of time the participant spent with glucose levels below the target range. Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored [CGM performs calculation]. This includes Level 1 hypoglycemia (54-69 mg/dL) and Level 2 hypoglycemia (<54 mg/dL).
Measured: 14 days
Glucose Level - Time In Range (TIR)
Percentage of time the participant spent within the target glucose range of 70-180 mg/dL. Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation].
Measured: 14 days
Glucose Management Indicator (GMI)
Estimated HbA1c percentage based on the average glucose levels captured by the CGM. Automated calculation based on 14 days of CGM data [CGM performs calculation]
Measured: 14 days
Glucose Variability (%GV)
Oscillations in blood glucose levels: Measurement of fluctuations of glucose or other related parameters of glucose homoeostasis over a given interval of time (i.e., within a day, between days or longer term). Calculation as the coefficient of variation (%CV). The goal for stable glycemic control is a variability of ≤36% [CGM performs calculation]
Measured: 14 days
Mean Glucose Level
This mean is calculated by taking the total sum of glucose averages divided by the total number of days of glucose readings [CGM performs calculation].
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start29 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, April Savoy, Indiana University
- Investigators
- April Savoy, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643144
- Sponsor's protocol ID
- 13925
- Other IDs
- 1K01AG076971
- Acronym
- CGM ASSIST
- Status last verified
- Aug 2026
- First submitted
- 11 Nov 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes
- ClinicalTrials.gov ID
- NCT05643144
- Acronym / sponsor ID
- CGM ASSIST / 13925
- Conditions
- Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia, Hypoglycemia
- Keywords
- Continuous glucose monitoring, Shared decision-making, Human factors, Primary care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Dec 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 goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors.
Managing diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings.
The study aims to:
- Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it.
- Improve Teamwork: Encourage "shared decision-making," where patients, caregivers, and doctors work together to make health choices.
- Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives.
- Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes.
By using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team.
Participants will:
- Answer a survey about how they manage their diabetes
- Learn how to use a Continuous Glucose Monitor and wear it for 14 days
- Answer 3 brief telephone surveys during these 14 days
- Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report
Detailed description
Background and Clinical Significance Over 11 million Americans aged 65 and older live with diabetes mellitus (DM), and an estimated 13-20% of this population also has Alzheimer's disease and related dementias (ADRD). Hypoglycemia is a serious and frequent complication in this population, affecting 10-25% of patients and increasing the risk of coma, macrovascular events, and death.
A harmful cycle exists in ADRD-DM management: cognitive impairment hinders the detection of hypoglycemia and the management of glucose levels, while low glucose levels further impair cognition. Although clinical guidelines recommend de-intensifying medications and simplifying routines to reduce risk, these guidelines are often not implemented in clinical practice.
The Role of Continuous Glucose Monitoring (CGM) Continuous glucose monitoring (CGM) devices are effective tools for detecting hypoglycemia by tracking glucose levels every 5-15 minutes. While CGM has proven feasible in older adults without cognitive impairment, research indicates that standard CGM data reports are often difficult for patients and caregivers to interpret. This lack of interpretability creates a barrier to shared decision-making regarding behavior modifications, glycemic targets, and medication de-intensification.
Study Objective: CGM ASSIST This study aims to address these translational gaps by developing and testing CGM ASSIST. This intervention adapts standard CGM technology by adding interactive information displays (novel companion information guides) designed specifically for the ADRD-DM population and their caregivers.
The study follows a multi-phase approach:
Characterization of Needs: Identifying the unmet needs and decision-making processes of patient-caregiver dyads using CGM.
User-Centered Design: Engaging patients, caregivers, and clinicians in a design process to create the CGM ASSIST interactive reports.
Pilot Testing: Conducting a clinical trial to assess the feasibility, usability, and impact of the CGM ASSIST reports on shared decision-making and individualized care.
The long-term goal of this research is to improve the characterization of decision-making in adults with MCI and ADRD and to provide tools that help families identify and address unmet medical needs through better interpretation of clinical data.
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 |
|---|---|---|
| Patient-Caregiver Dyads | Experimental | Device: Continuous Glucose MonitoringParticipants will wear a continuous glucose monitor |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Continuous Glucose MonitoringCGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events. | Device | Patient-Caregiver Dyads |
Primary outcome
Feasibility- Recruitment
Time frame: 8 months
Total number of participants enrolled divided by the total participants screened as eligible.
Feasibility- Retention
Time frame: 2 months
Total number of participants who completed the study divided by the total number of participants enrolled in the study.
Feasibility- CGM Device Adherence
Time frame: 14 days
This measures data completeness. Total number of days CGM worn and active divided by the total number of days in the observation period.
System Usability Scale
Time frame: 2 months
The System Usability Scale (SUS) is a 10-item validated questionnaire used to evaluate the usability of the CGM ASSIST interactive information display. Participants rate each item on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). To calculate the final SUS score, the response for each odd-numbered item is reduced by 1, and the response for each even-numbered item is subtracted from 5. These adjusted scores are then summed and multiplied by 2.5. The total score ranges from 0 to 100. A higher score indicates better usability (e.g., a score above 68 is generally considered above average).
CollaboRATE Questionnaire
Time frame: 2 months
The CollaboRATE questionnaire is a 3-item validated patient-reported measure used to assess the level of shared decision-making during clinical encounters. The three items focus on how much effort was made: 1) to help the participant understand their health issues, 2) to listen to what matters most to the participant, and 3) to include the participant's preferences in the choice of next steps. Each item is scored on a 5-point Likert scale ranging from 1 (No effort was made) to 5 (Every effort was made). For each participant, a total score is calculated by summing the scores of the three items. The total score ranges from 3 to 15. A higher score indicates a higher perceived level of shared decision-making.
Number of Changes in Diabetes Management
Time frame: 12 months
This measure tracks the total number of management changes made to a participant's diabetes care plan based on medical record review. A "change" is defined as any of the following: 1) Initiation of new medications or technology, 2) New referrals to specialists or community services, 3) Discontinuation of existing medications, and 4) Modification (increase or decrease) of current medication dosages.
5 secondary outcomes
Hypoglycemia - Time Below Range (TBR)
Time frame: 14 days
Glucose Level - Time In Range (TIR)
Time frame: 14 days
Glucose Management Indicator (GMI)
Time frame: 14 days
Glucose Variability (%GV)
Time frame: 14 days
Mean Glucose Level
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
April Savoy, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring in people with Diabetes and Alzheimer's Disease (Incl Subtypes), run by Indiana University 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?
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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact April Savoy, PhD (317-278-2194, asavoy@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Recruitment (time frame: 8 months). The study lists 6 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 5 Oct 2026.