NCT05711108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

January 24, 2023

Last Update Submit

October 20, 2025

Conditions

DiabetesHypoglycemiaAging

Keywords

older adultshypoglycemiacontinuous glucose monitoringlong-term care facilities

Outcome Measures

Primary Outcomes (1)

  • Biochemical hypoglycemia

    minutes per day sensor glucose \<70 mg/dL

    Baseline

Secondary Outcomes (6)

  • A1C

    Baseline

  • Time-in-range

    Baseline

  • Clinically significant hypoglycemia

    Baseline

  • Severe hypoglycemia

    Baseline

  • Falls, hospitalization

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Long Term Care Residents Using Glucose Lowering Medication

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Long term care residents using glucose lowering medications

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

January 19, 2022

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

October 22, 2025

Record last verified: 2025-10

Locations

US(1)