DiabetesNCT06658067
Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access
A study testing Continuous Glucose Monitor (CGM) in people with Diabetes and Type 2 Diabetes, run by Yale University at 1 site in United States.
Trial summary
This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus - Poor Control
- What is being tested?
- Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with type 2 diabetes mellitus
- A1c greater than or equal to 8.0 within two weeks of the time of enrollment
- On insulin for at least one year +/- other antihyperglycemics
- Ability and willingness to wear CGM for 14-day periods throughout the trial period
Show all 9Show fewer
- Ability and willingness to comply with provider-directed adjustments to medication regimen
- Inability to afford CGM sensors
- A note on Vulnerable Populations: Many of FHCHC's patients are economically disadvantaged and of minority backgrounds; the clinic's patient base may be considered to constitute a vulnerable population. As such, recruitment and enrollment will be conducted within a vulnerable population. The nature of the study requires this, and the results are intended to directly benefit this population through the potential for improved glycemic control and quality of life.
Who cannot join
- Insulin naïve
- Diabetic ketoacidosis (DKA) in previous 6 months
- End-Stage Renal Disease (ESRD)
- Contraindications to CGM use
- Active insurance plan that would provide enough of a subsidy for participant to feasibly purchase CGM sensors
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fair Haven Community Health Care (FHCHC)
New Haven, Connecticut, 06520
About this study
Official title: CGMs for All: Studying the Impact of Expanding CGM Access
This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life.
Read the detailed description
This study will enroll adult patients with type 2 diabetes and A1c of 8.0 or greater despite long-term use of insulin who are underinsured and under-resourced , meaning they are unable to reasonably afford CGM sensors. The participants will be chosen from among the panels of three providers.
This study aims to determine whether providing CGMs free of charge to patients with poorly controlled diabetes who could not otherwise afford them positively impacts their glycemic control and quality of life.
FHCHC's clinicians will identify adult patients from their panel with type 2 diabetes and poor glycemic control (A1c at least 8) on insulin who may be unable to afford CGM. Once consented, participants will have point-of-care A1c testing as well as pregnancy testing (if applicable); patient eligibility based on glycemic control criterion should be determined by this A1c. Participants will then complete the study questionnaires. Clinic staff will teach CGM sensor placement and determine whether a reader is required or if a compatible mobile device for intermittent scanning will be used. Blood Glucose (BG) readings are provided via online Libre portal.
At the 6-week follow-up visit, the provider will recommend adjustments to the participant's medication regimen based on their BG trends on CGM and their clinical judgment. Providers will ask participants to report any adverse events, safety issues, or trouble with the CGM system thus far experienced.
At the 12-week follow-up visit, participants will repeat completion of study questionnaires and undergo second A1c measurement. Further adjustment to medication regimen is permitted as provider sees fit.
At the 24-week follow-up visit, participants will repeat completion of study questionnaires for a third time and undergo third A1c measurement.
- Being tested
- Continuous Glucose Monitor (CGM)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM)Device
The first CGM sensor will be applied as directed during the first visit with a brief training by staff. Participant will be instructed to remove and replace the device every 14 days for the remainder of the 3-month trial period. Participant will also be instructed to scan the sensor three times daily. Compliance may be tracked via remote accessing of the blood glucose log on the online FreeStyle portal. CGM models used will include the Abbott FreeStyle Libre 2 and 3 and Dexcom G5, G6 and G7.
| Study group | Role | What they receive |
|---|---|---|
| Poorly Controlled Type 2 Diabetes- CGM | Experimental | Participants will have CGM sensor placed at first visit and will be worn for 12 weeks. Sensor must be scanned 3 times daily. Adjustments to medication regimen will be recommended at 6 weeks. Follow-up appointments will be at 12 weeks and 24 weeks. Receives: Device: Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Illness Intrusiveness Ratings Scale score (IIRS)
The IIRS is a useful, easy-to-apply tool that measures the degree of illness-induced disruptions in the 13 different aspects of life. Total score range from 13 (minimal intrusiveness) to 91 (extreme intrusiveness).
Measured: Baseline, 12 weeks, 24 weeks
Mean Hemoglobin A1c concentration
Mean A1c concentration in mg/dL measured in blood samples
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (6)
Mean Treatment Burden Questionnaire (TBQ) score
The TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem), to 10 (big problem). Item scores can be summed into a total score, ranging from 0 to 130. Higher scores indicate higher burden.
Measured: Baseline, 12 weeks, 24 weeks
Mean Diabetes Distress Scale score (DDS-17)
DDS-17 is a 17-item measure that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) concerning distress experienced over the last month. Total score range from 1 to 6 with higher scores indicating more distress.
Measured: Baseline, 12 weeks, 24 weeks
Mean Summary of Diabetes Self-Care Activities (SDSCA) score
The SDSCA is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.Total score range is 7-70. Higher scores indicate more days spent doing diabetes self-care activities (such as checking blood sugar, following a diet plan, and participating in exercise activities).
Measured: Baseline, 12 weeks, 24 weeks
Score on digital supplement to TBQ (TBQ+D)
The TBQ+D adds an additional 6 items to the TBQ, each rated on a Likert scale ranging from 0 (not a problem) to 10 (big problem). Item scores can be summed into a total score, ranging from 0 to 60. Higher scores indicate higher burden incurred by the use of digital health devices.
Measured: Baseline, 12 weeks, 24 weeks
Quality of life analogue scale
This scale asks respondents to rate how diabetes has affected their quality of life over the last 2 weeks on a scale from 0 (the worst it has ever been) to 10 (the best it has ever been). Higher scores indicate better perceived quality of life.
Measured: Baseline, 12 weeks, 24 weeks
TBQ+D Cognitive Interview tool
Cognitive Interview Tool: 10 participants will be asked to complete the TBQ+D survey aloud and provide their thoughts about the questions included. These recordings will be transcribed and evaluated qualitatively for recurrent themes.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start12 Nov 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale Office of Global Health
- Responsible party
- Sponsor
- Investigators
- Kasia Lipska, MD MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658067
- Sponsor's protocol ID
- 2000038335
- Status last verified
- Dec 2025
- First submitted
- 22 Oct 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual study data for the participants completing the Cognitive Interview Tool will be deidentified and shared with collaborators at the Mayo Clinic. Investigators have completed a Data Usage Agreement (DUA) with the Yale Office of Sponsored Projects (OSP).
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGMs for All: Studying the Impact of Expanding CGM Access
- ClinicalTrials.gov ID
- NCT06658067
- Acronym / sponsor ID
- 2000038335
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Yale Office of Global Health
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Oct 2024 (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.
This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life.
Detailed description
This study will enroll adult patients with type 2 diabetes and A1c of 8.0 or greater despite long-term use of insulin who are underinsured and under-resourced , meaning they are unable to reasonably afford CGM sensors. The participants will be chosen from among the panels of three providers.
This study aims to determine whether providing CGMs free of charge to patients with poorly controlled diabetes who could not otherwise afford them positively impacts their glycemic control and quality of life.
FHCHC's clinicians will identify adult patients from their panel with type 2 diabetes and poor glycemic control (A1c at least 8) on insulin who may be unable to afford CGM. Once consented, participants will have point-of-care A1c testing as well as pregnancy testing (if applicable); patient eligibility based on glycemic control criterion should be determined by this A1c. Participants will then complete the study questionnaires. Clinic staff will teach CGM sensor placement and determine whether a reader is required or if a compatible mobile device for intermittent scanning will be used. Blood Glucose (BG) readings are provided via online Libre portal.
At the 6-week follow-up visit, the provider will recommend adjustments to the participant's medication regimen based on their BG trends on CGM and their clinical judgment. Providers will ask participants to report any adverse events, safety issues, or trouble with the CGM system thus far experienced.
At the 12-week follow-up visit, participants will repeat completion of study questionnaires and undergo second A1c measurement. Further adjustment to medication regimen is permitted as provider sees fit.
At the 24-week follow-up visit, participants will repeat completion of study questionnaires for a third time and undergo third A1c measurement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poorly Controlled Type 2 Diabetes- CGM | Experimental | Device: Continuous Glucose Monitor (CGM)Participants will have CGM sensor placed at first visit and will be worn for 12 weeks. Sensor must be scanned 3 times daily. Adjustments to medication regimen will be recommended at 6 weeks. Follow-up appointments will be at 12 weeks and 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with type 2 diabetes mellitus
- A1c greater than or equal to 8.0 within two weeks of the time of enrollment
- On insulin for at least one year +/- other antihyperglycemics
Key exclusion criteria (6 listed)
- Insulin naïve
- Diabetic ketoacidosis (DKA) in previous 6 months
- End-Stage Renal Disease (ESRD)
- Contraindications to CGM use
- Active insurance plan that would provide enough of a subsidy for participant to feasibly purchase CGM sensors
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 Monitor (CGM)The first CGM sensor will be applied as directed during the first visit with a brief training by staff. Participant will be instructed to remove and replace the device every 14 days for the remainder of the 3-month trial period. Participant will also be instructed to scan the sensor three times daily. Compliance may be tracked via remote accessing of the blood glucose log on the online FreeStyle portal. CGM models used will include the Abbott FreeStyle Libre 2 and 3 and Dexcom G5, G6 and G7. | Device | Poorly Controlled Type 2 Diabetes- CGM |
Primary outcome
Mean Illness Intrusiveness Ratings Scale score (IIRS)
Time frame: Baseline, 12 weeks, 24 weeks
The IIRS is a useful, easy-to-apply tool that measures the degree of illness-induced disruptions in the 13 different aspects of life. Total score range from 13 (minimal intrusiveness) to 91 (extreme intrusiveness).
Mean Hemoglobin A1c concentration
Time frame: Baseline, 12 weeks, 24 weeks
Mean A1c concentration in mg/dL measured in blood samples
6 secondary outcomes
Mean Treatment Burden Questionnaire (TBQ) score
Time frame: Baseline, 12 weeks, 24 weeks
Mean Diabetes Distress Scale score (DDS-17)
Time frame: Baseline, 12 weeks, 24 weeks
Mean Summary of Diabetes Self-Care Activities (SDSCA) score
Time frame: Baseline, 12 weeks, 24 weeks
Score on digital supplement to TBQ (TBQ+D)
Time frame: Baseline, 12 weeks, 24 weeks
Quality of life analogue scale
Time frame: Baseline, 12 weeks, 24 weeks
TBQ+D Cognitive Interview tool
Time frame: Baseline, 12 weeks, 24 weeks
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 3 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual study data for the participants completing the Cognitive Interview Tool will be deidentified and shared with collaborators at the Mayo Clinic. Investigators have completed a Data Usage Agreement (DUA) with the Yale Office of Sponsored Projects (OSP).
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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.
Kasia Lipska, MD MHS principal investigator
Yale University
1 site 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 (CGM) in people with Diabetes and Type 2 Diabetes, run by Yale University 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 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: looking for participants now, as of the sponsor's last update on 3 Dec 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?
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?
Contact Justin A Dower, MD ((973) 901-4431, justin.dower@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Illness Intrusiveness Ratings Scale score (IIRS) (time frame: Baseline, 12 weeks, 24 weeks). 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 3 Dec 2025.