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

Continuous Glucose Monitoring (CGM) to Assess Hypoglycemia in Older Adults With Diabetes in Long Term Care (LTC) Facilities

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia; Diabetes; Aging

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Long term care residents using glucose lowering medications

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Long Term Care Residents Using Glucose Lowering Medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical hypoglycemia	minutes per day sensor glucose <70 mg/dL	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C		Baseline
Time-in-range	percent/day over 10 days of glucose value between 90-180 mg/dl or 90-250 mg/dl depending current ADA recommendations)	Baseline
Clinically significant hypoglycemia	minutes per day sensor glucose <54 mg/dl	Baseline
Severe hypoglycemia	needing 3rd party assistance	Baseline
Falls, hospitalization		Baseline
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

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Collaborators: Theoria Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: older adults; hypoglycemia; continuous glucose monitoring; long-term care facilities
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus
• Other Study ID Numbers: STUDY00000128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No