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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05711108

Enrollment

Registered

2023-02-02

Start date

2022-01-19

Completion date

2024-12-31

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Diabetes, Hypoglycemia

Keywords

older adults, hypoglycemia, continuous glucose monitoring, long-term care facilities

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
A1C	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	—
Severe hypoglycemia	Baseline	needing 3rd party assistance

Countries

United States

Outcome results