DiabetesNCT05711108
Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities
An observational study of Diabetes and Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Hypoglycemia, Aging
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Long term care residents using glucose lowering medications
Who may be able to join
- Adults >64 years with diagnosis of type 1 or type 2 diabetes
- Using glucose-lowering medication or insulin
Who cannot join
- Currently taking or planning to take hydroxyurea
- Patient or Health care proxy refuses to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes, Hypoglycemia, Aging
- Keywords
- older adults, hypoglycemia, continuous glucose monitoring, long-term care facilities
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long Term Care Residents Using Glucose Lowering Medication | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical hypoglycemia
minutes per day sensor glucose <70 mg/dL
Measured: Baseline
Secondary outcomes (6)
A1C
Measured: 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)
Measured: Baseline
Clinically significant hypoglycemia
minutes per day sensor glucose <54 mg/dl
Measured: Baseline
Severe hypoglycemia
needing 3rd party assistance
Measured: Baseline
Falls, hospitalization
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start19 Jan 2022
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Theoria Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711108
- Sponsor's protocol ID
- STUDY00000128
- Status last verified
- Oct 2025
- First submitted
- 24 Jan 2023
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring (CGM) to Assess Hypoglycemia in Older Adults With Diabetes in Long Term Care (LTC) Facilities
- ClinicalTrials.gov ID
- NCT05711108
- Acronym / sponsor ID
- STUDY00000128
- Conditions
- Diabetes, Hypoglycemia, Aging
- Keywords
- older adults, hypoglycemia, continuous glucose monitoring, long-term care facilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Theoria Medical
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long Term Care Residents Using Glucose Lowering Medication | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Long term care residents using glucose lowering medications
Key inclusion criteria (2 listed)
- Adults >64 years with diagnosis of type 1 or type 2 diabetes
- Using glucose-lowering medication or insulin
Key exclusion criteria (2 listed)
- Currently taking or planning to take hydroxyurea
- Patient or Health care proxy refuses to sign consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical hypoglycemia
Time frame: Baseline
minutes per day sensor glucose <70 mg/dL
6 secondary outcomes
A1C
Time frame: Baseline
Time-in-range
Time frame: Baseline
Clinically significant hypoglycemia
Time frame: Baseline
Severe hypoglycemia
Time frame: Baseline
Falls, hospitalization
Time frame: 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)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical hypoglycemia (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.