Technological Advances in Glucose Management in Older Adults
NCT03078491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2026-05-12
Summary
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.
Conditions
- Type 1 Diabetes Mellitus
- Older Adults
- Hypoglycemia
Interventions
- OTHER
-
eCGM (enhanced CGM)
Glucose (CGM and Bluetooth BG meter), insulin (pump or Bluetooth insulin pen) and activity data will be automatically uploaded via the subjects' tablet computers, and analyzed by the CDS. The CDS will, if indicated generate adjustable insulin dosing recommendations that will compensate for different insulin requirements following high vs low activity days. The recommendations of the CDS will be used by the clinical team in their therapeutic decision-making about insulin dosing adjustments at the scheduled study follow up visits and the remote visits between these in-person visits. In addition, study staff will provide recommendations regarding hypoglycemic warning symptoms, causes, and appropriateness of treatment.
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
collaborator OTHER - collaborator OTHER
-
RTI International
collaborator OTHER -
Joslin Diabetes Center
lead OTHER
Principal Investigators
-
Medha N Munshi, MD · Joslin Diabetes Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-30
- Primary Completion
- 2022-09-01
- Completion
- 2022-10-01
Countries
- United States
Study Locations
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