Helping older adults with diabetes and mild cognitive impairment manage their condition with technology and care partners
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
This study is testing if giving older adults with diabetes and mild cognitive issues a device to monitor their blood sugar can help them manage their condition better with the support of their care partners.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05601583 on ClinicalTrials.gov |
What this trial studies
This study provides Continuous Glucose Monitoring (CGM) devices to older adults with Type 2 Diabetes and Mild Cognitive Impairment (T2D-MCI) to enhance their diabetes self-management. Participants will share their glucose data with care partners, who will assist in daily decision-making regarding their diabetes care. After two weeks of using the CGM, individual interviews will be conducted with both the older adults and their care partners to evaluate the effectiveness of this Care Partner-Assisted Intervention. The study aims to empower participants through real-time glucose monitoring and alerts, addressing the challenges posed by cognitive impairment in managing diabetes.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above with Type 2 Diabetes and Mild Cognitive Impairment who have a supportive care partner.
Not a fit: Patients with serious physical illnesses or significant mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve diabetes management and health outcomes for older adults with cognitive challenges.
How similar studies have performed: Other studies have shown promise in using technology for diabetes management, but this specific approach linking CGM with care partners is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Older adults must meet all of the following criteria: 1. be ≥ 65 years old; 2. have had a diagnosis of T2D for at least one year; 3. have MCI, defined as score 19-25 on the Montreal Cognitive Assessment (MoCA);60,61 4. have a care partner (e.g., spouse or adult children); 5. be willing to use CGM; 6. be fluent in English. Eligible care partners must be: 1. ≥ 18 years old; 2. living with older adults with T2D-MCI; 3. willing to be involved in patients' daily care; 4. fluent in English. Exclusion Criteria: Older adults who meet any of the following criteria will be excluded from participation in this study: 1. Refuse or are unable to provide informed consent; 2. Have serious physical illness (e.g., end-stage renal disease); 3. Presence of mental illness (e.g., schizophrenia or bipolar disorder) that would preclude participation. The care partners will be excluded if they: 1. Refuse or are unable to provide informed consent; 2. Have MCI.
Where this trial is running
New York, New York
- Bellevue Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Yaguang Zheng, PhD, RN — Rory Meyers College of Nursing
- Study coordinator: Yaguang Zheng
- Email: Yaguang.zheng@nyu.edu
- Phone: 212-998-5170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.