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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01AG076971 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Caregiver Dyads | Experimental | Participants will wear a continuous glucose monitor |
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| Patient-Caregiver Dyads & Clinicians (first iteration) | No Intervention | Participants will participate in the first iteration of the user-centered design process. | |
| Patient-Caregiver Dyads & Clinicians (second iteration) | No Intervention | Participants will participate in the second iteration of the user-centered design process. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility- Recruitment | Total number of participants enrolled divided by the total participants screened as eligible. | 8 months |
| Feasibility- Retention | Total number of participants who completed the study divided by the total number of participants enrolled in the study. | 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. | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 14 days |
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Patient-Caregiver Dyad Inclusion Criteria (Aims 1 + 2):
Patient-Caregiver Dyad Exclusion Criteria (Aims 1 +2):
Clinician Participant Inclusion Criteria (Aim 2):
Clinician Participant Exclusion Criteria (Aim 2):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| April Savoy, PhD | Contact | 317-278-2194 | asavoy@iu.edu | |
| Nina Johnson, MA | Contact | 317-274-9086 | kj83@regenstrief.org |
| Name | Affiliation | Role |
|---|---|---|
| April Savoy, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. | 12 months |
| 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]. | 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] | 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] | 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]. | 14 days |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |