Technological Advances in Glucose Management in Older Adults
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus, Older Adults, Hypoglycemia
In brief
This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. The DMP includes an automated data transfer from CGM, insulin-delivery devices, and activity tracker to a clinical decision support system (CDS) that provides dosing adjustment recommendations based on that data to the healthcare team. In addition, the DMP includes on-demand education for patients and caregivers, and an interface for communication between providers, patients, and their caregivers.
Key facts
- Study ID
- NCT03078491
- Run by
- Joslin Diabetes Center
- People needed
- 168
- Starts
- 2017-03-30
- Expected to finish
- 2022-10-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with age ≥ 65 years
- Community-living
- Clinical diagnosis of T1D
- On multiple insulin injections (≥3 injection/s day) or insulin pump.
You may not qualify if…
- Use of real-time CGM in past 2 years
- A1c > 10% (since individuals with very poor glycemic control usually have barriers to optimal self-care that preclude effective use of technology)
- Use of insulin pump that cannot be uploaded for CDS
- Unable or unwilling to perform task needed for study participation during the run-in period
- Severe vision or hearing impairment that could interfere with study tasks
- Need to use acetaminophen on regular basis (since can interfere with CGM accuracy)
- Living in an institutional setting (e.g. group homes, nursing homes)
- Terminal diseases with life expectancy < 1 year (e.g. malignancy)
- Severe comorbidities that prevent completing outcome measurements (e.g. severe dementia, severe vision impairment, severe functional disabilities, inability to perform basic activities of daily living)
- Alcohol or other drug abuse
- Conditions that impact wear of CGM (e.g. CHF with edema, skin conditions); and
- End stage renal insufficiency (eGFR<30), or on dialysis (since impact of fluid shift on sensor lag not clearly understood).
Where it is running
- Joslin Diabetes Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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