Type 2 DiabetesPhase 1CP-CGMHNCT05601583
Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive Impairment
A Phase 1 study testing Continuous Glucose Monitor (CGM) in people with Type 2 Diabetes and Mild Cognitive Impairment, run by NYU Langone Health at 1 site in United States.
Trial summary
Eligible older adults with Type 2 Diabetes-Mild Cognitive Impairment (T2D-MCI) will be provided a Continuous Glucose Monitoring (CGM) device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Type 2 Diabetes, Mild Cognitive Impairment
- What is being tested?
- Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2023to 14 Aug 2026
- Phase
- Phase 1
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults must meet all of the following criteria:
- be ≥ 65 years old;
- have had a diagnosis of T2D for at least one year;
- have MCI, defined as score 19-25 on the Montreal Cognitive Assessment (MoCA);60,61
- have a care partner (e.g., spouse or adult children);
- be willing to use CGM;
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- be fluent in English.
- Eligible care partners must be:
- ≥ 18 years old;
- living with older adults with T2D-MCI;
- willing to be involved in patients' daily care;
- fluent in English.
Who cannot join
- Older adults who meet any of the following criteria will be excluded from participation in this study:
- Refuse or are unable to provide informed consent;
- Have serious physical illness (e.g., end-stage renal disease);
- Presence of mental illness (e.g., schizophrenia or bipolar disorder) that would preclude participation.
- The care partners will be excluded if they:
- Refuse or are unable to provide informed consent;
- Have MCI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CP-CGMH: Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive Impairment
Eligible older adults with Type 2 Diabetes-Mild Cognitive Impairment (T2D-MCI) will be provided a Continuous Glucose Monitoring (CGM) device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management. After 2 weeks, individual interviews will be conducted in 20 participants (10 dyads). Older adults with T2D-MCI (n=10) and their care partners (n=10) will be interviewed separately to identify key features of the Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health (CP-CGMH) app.
Read the detailed description
CGM sensors, measuring glucose levels every 1-5 minutes, can identify hyper- or hypoglycemic episodes that might not be captured by the routine glucose monitoring using finger stick. CGM also enables sharing real-time glucose values and visual trends with care partners as well as provides alerts and alarms when glucose levels are extremely high or low. These visual and alert cues can be used to inform and empower self-management decision making as well as motivate and engage self-management behavior changes (e.g., adjust insulin dose, reduce high-carbohydrate food intake, and increase exercise), which may address the unique issue of diabetes management caused by cognitive impairment for older adults with T2D-MCI. The investigators will use FDA cleared FreeStyle Libre Glucose Monitoring System (hereon referred to as the 'FreeStyle Libre System or 'System'), which is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The use of this device provides ambulatory glucose profiles, giving graphic and quantitative information on 24-hour glucose patterns. It does not require finger-prick testing for calibration. The system consists of a reader and a sensor (35 mm x 5 mm). The sensor is applied to the back of a person's arm. The sensor automatically measures interstitial glucose at 1-minute intervals during daily activities like work, sleep, eating, and exercise. It is able to store blocks of glucose data for 14 days. Unlike previous versions, with this device, patients are not required to perform finger-stick blood glucose monitoring for calibration. Patients can use the reader or their personal smartphone to scan the CGM sensor to get the real-time glucose values. After 2- week wearing, the participants will return to the research lab (final assessment) to download the CGM report from the LibreView. The data can be viewed as graphical data and summary statistics, or as numerical data. The data report will be de-identified by the study's appointed trained RA before the data are used for analysis. The manufacturer of the device was not involved in the funding, the design or the interpretation of the study.
- Conditions
- Type 2 Diabetes, Mild Cognitive Impairment
- Being tested
- Continuous Glucose Monitor (CGM)
- Keywords
- Continuous Glucose Monitoring (CGM)
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM)Device
Also called Freestyle Libre CGM
FDA-cleared FreeStyle Libre Glucose Monitoring System manufactured by Abbott. Integrated continuous glucose monitoring system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts.
| Study group | Role | What they receive |
|---|---|---|
| CP-CGMH | Experimental | CP-CGMH: Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health.
Participants will receive a CGM device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management for two weeks. The LibreLinkup mHealth app will be used to share data. Receives: Device: Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technology Acceptance Subscale Score
13-item questionnaire assessing participants' acceptance of the CGM technology. Items ranked on 7-point Likert scale ranging from 1-7. The total score is the sum of responses and ranges from 13 to 91; lower scores indicate greater overall acceptance.
Measured: Day 14
Total CGM Use Time
Measured: Up to Day 14
Total Scan Time
Patients can use the reader or their personal smartphone to scan the CGM sensor to get the real-time glucose values.
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start19 Apr 2023
- Primary completion29 Aug 2023
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaguang Zheng, PhD, RN, Principal investigator, Rory Meyers College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601583
- Sponsor's protocol ID
- 22-01170
- Acronym
- CP-CGMH
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Yaguang.zheng@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CP-CGMH: Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05601583
- Acronym / sponsor ID
- CP-CGMH / 22-01170
- Conditions
- Type 2 Diabetes, Mild Cognitive Impairment
- Keywords
- Continuous Glucose Monitoring (CGM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 1 Nov 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.
Eligible older adults with Type 2 Diabetes-Mild Cognitive Impairment (T2D-MCI) will be provided a Continuous Glucose Monitoring (CGM) device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management. After 2 weeks, individual interviews will be conducted in 20 participants (10 dyads). Older adults with T2D-MCI (n=10) and their care partners (n=10) will be interviewed separately to identify key features of the Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health (CP-CGMH) app.
Detailed description
CGM sensors, measuring glucose levels every 1-5 minutes, can identify hyper- or hypoglycemic episodes that might not be captured by the routine glucose monitoring using finger stick. CGM also enables sharing real-time glucose values and visual trends with care partners as well as provides alerts and alarms when glucose levels are extremely high or low. These visual and alert cues can be used to inform and empower self-management decision making as well as motivate and engage self-management behavior changes (e.g., adjust insulin dose, reduce high-carbohydrate food intake, and increase exercise), which may address the unique issue of diabetes management caused by cognitive impairment for older adults with T2D-MCI. The investigators will use FDA cleared FreeStyle Libre Glucose Monitoring System (hereon referred to as the 'FreeStyle Libre System or 'System'), which is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The use of this device provides ambulatory glucose profiles, giving graphic and quantitative information on 24-hour glucose patterns. It does not require finger-prick testing for calibration. The system consists of a reader and a sensor (35 mm x 5 mm). The sensor is applied to the back of a person's arm. The sensor automatically measures interstitial glucose at 1-minute intervals during daily activities like work, sleep, eating, and exercise. It is able to store blocks of glucose data for 14 days. Unlike previous versions, with this device, patients are not required to perform finger-stick blood glucose monitoring for calibration. Patients can use the reader or their personal smartphone to scan the CGM sensor to get the real-time glucose values. After 2- week wearing, the participants will return to the research lab (final assessment) to download the CGM report from the LibreView. The data can be viewed as graphical data and summary statistics, or as numerical data. The data report will be de-identified by the study's appointed trained RA before the data are used for analysis. The manufacturer of the device was not involved in the funding, the design or the interpretation of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CP-CGMH | Experimental | Device: Continuous Glucose Monitor (CGM)CP-CGMH: Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health. Participants will receive a CGM device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management for two weeks. The LibreLinkup mHealth app will be used to share data. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- be ≥ 65 years old;
- have had a diagnosis of T2D for at least one year;
- have MCI, defined as score 19-25 on the Montreal Cognitive Assessment (MoCA);60,61
- have a care partner (e.g., spouse or adult children);
- be willing to use CGM;
Key exclusion criteria (7 listed)
- Older adults who meet any of the following criteria will be excluded from participation in this study:
- Refuse or are unable to provide informed consent;
- Have serious physical illness (e.g., end-stage renal disease);
- Presence of mental illness (e.g., schizophrenia or bipolar disorder) that would preclude participation.
- Refuse or are unable to provide informed consent;
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 Monitor (CGM)Also: Freestyle Libre CGMFDA-cleared FreeStyle Libre Glucose Monitoring System manufactured by Abbott. Integrated continuous glucose monitoring system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. | Device | CP-CGMH |
Primary outcome
Technology Acceptance Subscale Score
Time frame: Day 14
13-item questionnaire assessing participants' acceptance of the CGM technology. Items ranked on 7-point Likert scale ranging from 1-7. The total score is the sum of responses and ranges from 13 to 91; lower scores indicate greater overall acceptance.
Total CGM Use Time
Time frame: Up to Day 14
Total Scan Time
Time frame: Up to Day 14
Patients can use the reader or their personal smartphone to scan the CGM sensor to get the real-time glucose values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Yaguang.zheng@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Yaguang Zheng, PhD, RN principal investigator
Rory Meyers College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Continuous Glucose Monitor (CGM) in people with Type 2 Diabetes and Mild Cognitive Impairment, run by NYU Langone Health 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 12 inclusion and 7 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 27 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technology Acceptance Subscale Score (time frame: Day 14). The study lists 3 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 27 Aug 2026.