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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711108
• Other study ID #: STUDY00000128
• Status: Recruiting
• Start date: January 19, 2022
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Joslin Diabetes Center
• Contact: Christine Slyne
• Phone: 617-309-4683
• Email: christine.slyne[@]joslin.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Diabetes
• Hypoglycemia

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Theoria Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical hypoglycemia	minutes per day sensor glucose <70 mg/dL	Baseline
Secondary	A1C		Baseline
Secondary	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
Secondary	Clinically significant hypoglycemia	minutes per day sensor glucose <54 mg/dl	Baseline
Secondary	Severe hypoglycemia	needing 3rd party assistance	Baseline
Secondary	Falls, hospitalization		Baseline
Secondary	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