Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities

Recruiting

• Conditions: Diabetes; Aging; Hypoglycemia

• Registration Number: NCT05711108
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications).

This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adults >64 years with diagnosis of type 1 or type 2 diabetes
• Using glucose-lowering medication or insulin

Exclusion Criteria

• Currently taking or planning to take hydroxyurea
• Patient or Health care proxy refuses to sign consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical hypoglycemia	Baseline	minutes per day sensor glucose \<70 mg/dL

Secondary Outcome Measures

Name	Time	Method
Time-in-range	Baseline	percent/day over 10 days of glucose value between 90-180 mg/dl or 90-250 mg/dl depending current ADA recommendations)
Clinically significant hypoglycemia	Baseline	minutes per day sensor glucose \<54 mg/dl
Severe hypoglycemia	Baseline	needing 3rd party assistance
Symptoms of hypoglycemia reported to the staff by the resident in between or at the time of fingerstick glucose monitoring (information derived from nursing notes)	Baseline
Falls, hospitalization	Baseline
A1C	Baseline

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States