NCT03078491

Technological Advances in Glucose Management in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypoglycemia is a major and often devastating complication of T1D in the elderly. CGM has been shown to reduce the risk for hypoglycemia in adults with T1D including some more functional patients over 65 years old. However, the Medicare population is heterogeneous and may have age-related clinical and functional impairments that can impact self-care. These patients will require additional targeted guidance and support to fully realize the potential benefits of CGM. To address these age-specific barriers which could limit the effective use of CGM, in our planned RCT (Specific Aim 1) the use of CGM will be coupled with the DMP (Diabetes Management Platform), a tablet-based technology platform ( termed enhanced CGM (eCGM)). The CGM, insulin delivery, and activity data uploaded from the DMP will be analyzed by the clinical decision support system (CDS), which will provide insulin dosing recommendations to the study physicians, who will then accept or reject changes in therapy. The use of the DMP is expected to help the less technologically proficient Medicare patients to derive benefit from CGM. Specific Aim 2 will involve extensive mixed methods research (including semi-structured interviews of patients and caregivers) directed at making an in-depth assessment of barriers to the use of diabetes technology in older adults. This investigation will provide the evidence-base for future improvements in both the technology and clinical approach to the training of older adults and their caregivers. Specific Aim 3 will involve a cost-effectiveness analysis of the technology system (CGM with DMP = enhanced CGM \[eCGM\]) used in the trial as well as quality of life measures, providing a foundation for decision-making on coverage.

Conditions

• Type 1 Diabetes Mellitus
• Older Adults
• Hypoglycemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-30
• Primary completion: 2022-09-01
• Completion: 2022-10-01
• First posted: 2017-03-13
• Last updated: 2023-02-23

Locations

1 site across 1 country: United States