Diabetes MellitusRESTNCT05337826
The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes
A study testing Continuous Glucose Monitor in people with Diabetes Mellitus, run by Joslin Diabetes Center at 2 sites in United States.
Trial summary
To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Older adults age ≥65 years
- T1D or T2D with duration longer than 1 year
- Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy
- CGM naïve and/or CGM users (Dexcom G6) who are not meeting glycemic goals (per
- CGM metrics):
- ≥4% hypoglycemia (sensor glucose ≤70 mg/dL) or
Show all 9Show fewer
- time in range (70-180 mg/dL) TIR ≤40 %
- Willing to wear CGM Dexcom at all times while in the study
- Willing to use/carry personal or loaned smart phone device to use as Dexcom receiver for continual data upload to cloud
Who cannot join
- Life expectancy <1 year
- End-stage renal disease (eGFR< 30ml/min)
- On acetaminophen >4 gr/day due to interference with Dexcom G6 sensor readings
- On hydroxyurea therapy due to interference with Dexcom G6 sensor readings
- Impaired vision and hearing which would interfere with participation in remote video visits
- Use of hybrid closed-loop systems (this may require different and additional focused education and will not be addressed in this study).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Readiness, Education, and Sustainability for CGM Technology Adoption Model for Older Adults With Insulin-treated Diabetes
To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.
Read the detailed description
Older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. Use of continuous glucose monitoring (CGM) has shown to improve glycemic control and reduce hypoglycemia in this age group. Despite Medicare coverage for CGM, uptake in this age group is still low. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model. This model will assess Readiness and barriers to CGM initiation and utilization, provide remote Education, and implement a framework for Sustainability of CGM Technology adoption. The study will assess the impact of the REST model and its ability to increase CGM uptake and use in this age group, as well as its effectiveness on improving glycemic metrics. The study will also evaluate the impact of the REST model on economic and health-related quality-of-life measures.
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor
- Keywords
- older adults, CGM, diabetes technology, telehealth
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Also called the REST model
Participants will enroll in a series of remote educational visits conducted by CDCES to assess readiness and barriers to CGM initiation and utilization, with the goal to sustain use of CGM Technology over time in older populations on complex insulin regimen.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The co-primary effectiveness outcomes
Change in time spent in hypoglycemia (sensor glucose <70 mg/dL and ii) Change in individualized Time in Range goal
Measured: Baseline to 6 months
The co-primary implementation outcomes
Change in adoption of CGM by remote education (change in number of CGM users and ii) change in number of hours of CGM use per week
Measured: Baseline vs 6 months
Secondary outcomes (8)
Visits to maintain CGM use
Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use
Measured: 6 months
Visits to maintain CGM use
Total time spent and the number of remote and in-person visits needed to initiate and maintain CGM use
Measured: Month 12
Resource utilization
Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)
Measured: Baseline vs 6 months
Resource utilization
Change in resource utilization (episodes of severe hypoglycemia, emergency department visits, and hospitalizations)
Measured: 6 months vs 12 months
Time spent in hypoglycemia
Change in time spent in hypoglycemia ( sensor glucose <70 mg/dL)
Measured: 6 months vs 12 months
Cost effectivness
Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care
Measured: 6 months
Cost Effectivness
Cost-effectiveness ratios to assess the economic aspects for REST model compared standard of care
Measured: 12 months
Diabetes health related quality of life measures
Change in quality of life measures (diabetes distress, hypoglycemia fear, EQ-5D)
Measured: Baseline vs 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start20 Apr 2022
- Primary completion11 Nov 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Upstate Medical University, Cecilia Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337826
- Sponsor's protocol ID
- STUDY00000174
- Acronym
- REST
- Status last verified
- Aug 2026
- First submitted
- 5 Apr 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared to Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readiness, Education, and Sustainability for CGM Technology Adoption Model for Older Adults With Insulin-treated Diabetes
- ClinicalTrials.gov ID
- NCT05337826
- Acronym / sponsor ID
- REST / STUDY00000174
- Conditions
- Diabetes Mellitus
- Keywords
- older adults, CGM, diabetes technology, telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- State University of New York - Upstate Medical University, Cecilia Health
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Apr 2022 (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 assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.
Detailed description
Older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. Use of continuous glucose monitoring (CGM) has shown to improve glycemic control and reduce hypoglycemia in this age group. Despite Medicare coverage for CGM, uptake in this age group is still low. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model. This model will assess Readiness and barriers to CGM initiation and utilization, provide remote Education, and implement a framework for Sustainability of CGM Technology adoption. The study will assess the impact of the REST model and its ability to increase CGM uptake and use in this age group, as well as its effectiveness on improving glycemic metrics. The study will also evaluate the impact of the REST model on economic and health-related quality-of-life measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Continuous Glucose Monitor |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Older adults age ≥65 years
- T1D or T2D with duration longer than 1 year
- Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy
- CGM naïve and/or CGM users (Dexcom G6) who are not meeting glycemic goals (per
- ≥4% hypoglycemia (sensor glucose ≤70 mg/dL) or
Key exclusion criteria (6 listed)
- Life expectancy <1 year
- End-stage renal disease (eGFR< 30ml/min)
- On acetaminophen >4 gr/day due to interference with Dexcom G6 sensor readings
- On hydroxyurea therapy due to interference with Dexcom G6 sensor readings
- Impaired vision and hearing which would interfere with participation in remote video visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitorAlso: the REST modelParticipants will enroll in a series of remote educational visits conducted by CDCES to assess readiness and barriers to CGM initiation and utilization, with the goal to sustain use of CGM Technology over time in older populations on complex insulin regimen. | Device | Single Arm |
Primary outcome
The co-primary effectiveness outcomes
Time frame: Baseline to 6 months
Change in time spent in hypoglycemia (sensor glucose <70 mg/dL and ii) Change in individualized Time in Range goal
The co-primary implementation outcomes
Time frame: Baseline vs 6 months
Change in adoption of CGM by remote education (change in number of CGM users and ii) change in number of hours of CGM use per week
8 secondary outcomes
Visits to maintain CGM use
Time frame: 6 months
Visits to maintain CGM use
Time frame: Month 12
Resource utilization
Time frame: Baseline vs 6 months
Resource utilization
Time frame: 6 months vs 12 months
Time spent in hypoglycemia
Time frame: 6 months vs 12 months
Cost effectivness
Time frame: 6 months
Cost Effectivness
Time frame: 12 months
Diabetes health related quality of life measures
Time frame: Baseline vs 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared to Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor in people with Diabetes Mellitus, run by Joslin Diabetes Center at 2 sites 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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The co-primary effectiveness outcomes (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. 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 10 Aug 2026.