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OpenTrials
Completed

NCT Number: NCT05711108

Continuous Glucose Monitoring (CGM) 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.

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Key information

Conditions

Diabetes Aging Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Biochemical hypoglycemia

    Time frame: Baseline

    minutes per day sensor glucose <70 mg/dL

Secondary outcomes

  1. A1C

    Time frame: Baseline

  2. Time-in-range

    Time frame: Baseline

    percent/day over 10 days of glucose value between 90-180 mg/dl or 90-250 mg/dl depending current ADA recommendations)

  3. Clinically significant hypoglycemia

    Time frame: Baseline

    minutes per day sensor glucose <54 mg/dl

  4. Severe hypoglycemia

    Time frame: Baseline

    needing 3rd party assistance

  5. Falls, hospitalization

    Time frame: Baseline

  6. 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)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Theoria Medical

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2023
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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