Type 1 DiabetesNCT06487962
Pilot RCT: FQHC Intervention for Uptake of CGM in Low-Income Adults With T1D
A study testing CGM Intervention in people with Type 1 Diabetes, run by University of Connecticut at 2 sites in United States.
Trial summary
Low-income adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CGM Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2024to 1 Aug 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
- Low-income status
- Documented diagnosis of T1D
- 18 years of age or older
- Federally Qualified Health Center (FQHC) primary care provider
- English or Spanish-speaking And at intervention sites
- Willingness to wear a CGM sensor
- Adult family member or friend, who will give consent to participate in the study and co-attend the 4-week intervention sessions
- Reported difficulty in using CGM if current or past use of CGM
Who cannot join
- Pregnancy or planning to become pregnant
- Lactation
- Serious illness that may prevent study participation (e.g., severe depression)
- Less than 6 months life expectancy
- Alcohol abuse or dependence
- Uncorrected hearing or vision impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Community Health Center, Inc.
Middletown, Connecticut, 06457
Treasure Coast Community Health
Vero Beach, Florida, 32960
About this study
Low-income adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.
Read the detailed description
Low-income adults with T1D experience a disproportionate burden of life-threatening, acute complications with high rates of related emergency department visits, hospitalizations, and death. Use of CGM may mitigate these inequities. Yet, low-income adults with T1D have exceptionally low levels of CGM use. This reflects social determinants of health (SODH), as framed by the multiple levels of the Socio-Ecological Model (SEM). The SEM's healthcare provider level is a main driver in Hispanic disenfranchisement from CGM. With a severe shortage of endocrinologists, primary care providers are increasingly managing T1D although many report inadequate confidence in titrating insulin and using CGM. With limited access to endocrinology, low-income, Hispanic adults with T1D thus often receive diabetes management in FQHCs with scant or no access to CGM. Hence, to foster equitable uptake of CGM in the most vulnerable adults with T1D, a 4-year, mixed-methods, feasibility study with a pilot randomized controlled trial (RCT) is underway to primarily assess the feasibility of the SEM-guided, 6-month intervention (targeting the individual, family/social networks, and healthcare provider levels). The SEM-guided intervention was refined by our Community Advisory Board. Refinements were informed by qualitative research exploring SDOH barriers to CGM uptake in low-income adults with T1D from the perspectives of four stakeholder groups.
The individual level of the intervention, guided by the Information-Motivation-Behavioral-Skills Model, fosters essential acquisition of information, motivation, and behavioral skills for CGM uptake through two principal approaches: (1) 4-week, personalized, CGM sessions with a RN/ certified diabetes care and education specialist (CDCES); and (2) subsequent virtual peer educator-led support groups, integrating CGM education, through study month six. The family/social networks level leverages social support to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement in peer-led support group sessions, respectively. The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes).
A total of 11 FQHC sites were randomized to deliver the intervention (n=6) or control (n=5) conditions with a total enrollment goal of 30 low-income adults with T1D (sites having roughly equivalent enrollment rates). The feasibility of the study protocol (e.g., recruitment and retention yields, data collection procedures, intervention implementation, and intervention acceptability, among others) will be routinely assessed. Significant intervention signals in terms of physiological (e.g., A1C and time within, above, and below range glucose range), psychosocial (e.g., quality of life and family support), and behavioral (CGM adherence) outcomes from baseline to 3- and 6-months post-baseline will be assessed. The long-term goal of this study is to inform a large, multi-site RCT, and with successful results, provide a model for CGM uptake in low-income adults with T1D for FQHCs nationally
- Conditions
- Type 1 Diabetes
- Being tested
- CGM Intervention, SMBG Control Condition
- Keywords
- Continuous Glucose Monitor, Hispanic Adult, Family, Social Ecological Model
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM InterventionDevice
The intervention has 4 components with CGM uptake and maintenance as a primary focus. (1) Participants will visit their primary care provider (PCP) at baseline and 3- and 6-months post-baseline (or more frequently as needed) for review of CGM data and insulin therapy adjustments as indicated. Intervention providers received rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes). (2) After each PCP visit, the CDCES will follow-up with participants to ensure participant understanding of the education/instructions provided at the PCP visit. (3) Next, participants will receive 4-weekly sessions of culturally sensitive, intensive CGM education and training led by a CDCES with accompaniment of a supportive family member or friend. (4) Virtual group support sessions, led by a peer educator, will follow over 5 months. During this period, the peer-led sessions will take place every two weeks and then move to every three weeks.
SMBG Control ConditionOther
The SMBG control condition consists of 3 components delivered over 6 months. (1) Participants will visit their PCP at baseline and 3- and 6-months post-baseline (or more frequently as needed) for review of SMBG data and insulin therapy adjustments as indicated. Control providers received rigorous training in T1D management via Project ECHO. (2) Commencing after the first PCP visit, participants will have 4-weekly telehealth visits for knowledge and skills reinforcement for SMBG. (3) CDCES support phone calls will follow over 5 months. During this period, the support phone calls will take place every two weeks and then move to every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Intervention Arm | Experimental | The intervention arm comprises participants receiving care from FQHC sites randomized to deliver the intervention. This arm will receive the 6-month, SEM-informed intervention to promote CGM uptake and maintenance. Receives: Device: CGM Intervention |
| Self-Monitoring of Blood Glucose (SMBG) Arm | Other | The SMBG control arm comprises participants receiving care from FQHC sites randomized to deliver the control condition. This arm will receive the 6-month control condition. Receives: Other: SMBG Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days CGM worn
The total number of days CGM worn. Data will be collected from Ambulatory Glucose Profile Reports.
Measured: 3 months and 6 months
Percentage of time the CGM is active
The percentage of time the CGM is active. Data will be collected from Ambulatory Glucose Profile Reports.
Measured: 3 months and 6 months
Secondary outcomes (11)
A1C
Measure of glycemic control over the past 3 months
Measured: Baseline, 3 months, and 6 months
CGM time in range (TIR)
TIR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports.
Measured: 3 months and 6 months
CGM time below range (TBR)
TBR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports.
Measured: 3 months and 6 months
CGM time above range (TAR)
TAR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports.
Measured: 3 months and 6 months
Number of hypoglycemic-related emergency department (ED) visits over past 3 months
1-item measure
Measured: Baseline, 3 months, and 6 months
Number of hypoglycemic-related hospitalizations
1-item measure
Measured: Baseline, 3 months, and 6 months
Number of hyperglycemic-related ED visits
1-item measure
Measured: Baseline, 3 months, and 6 months
Number of hyperglycemic-related hospitalizations
1-item measure
Measured: Baseline, 3 months, and 6 months
Medical Outcomes Survey Short Form-36
Quality of Life
Measured: Baseline, 3 months, and 6 months
Multidimensional Scale of Perceived Social Support
Social Support
Measured: Baseline, 3 months, and 6 months
Interpersonal Processes of Care Survey: Short Form
Disparities in Interpersonal Care (communication, decision-making, and interpersonal style)
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start28 May 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a mixed-methods, pragmatic pilot RCT design. Mixed-methods will be used to assess study feasibility and acceptability while quantitative methods will be used to assess RCT outcomes. As a pragmatic trial, the intervention (except peer-led support sessions) and control conditions are embedded in routine FQHC diabetes care in the participating sites.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelley Newlin Lew, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487962
- Sponsor's protocol ID
- 24-08-011-910
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Newlin-Lew K, Perez-Brescia M, Channamsetty V, Salas-Vega M, Krol M, Jacque F, Lippman C, Allen NA. Continuous Glucose Monitoring Intervention for Hispanic Adults With Type 1 Diabetes Receiving Care in a Federally Qualified Health Center: Protocol for a Mixed Methods, Pragmatic Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 2;15:e60583. doi: 10.2196/60583.
PubMed 42228938
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT: FQHC Intervention for Uptake of CGM in Low-Income Adults With T1D
- ClinicalTrials.gov ID
- NCT06487962
- Acronym / sponsor ID
- 24-08-011-910
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous Glucose Monitor, Hispanic Adult, Family, Social Ecological Model
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Jul 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.
Low-income adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.
Detailed description
Low-income adults with T1D experience a disproportionate burden of life-threatening, acute complications with high rates of related emergency department visits, hospitalizations, and death. Use of CGM may mitigate these inequities. Yet, low-income adults with T1D have exceptionally low levels of CGM use. This reflects social determinants of health (SODH), as framed by the multiple levels of the Socio-Ecological Model (SEM). The SEM's healthcare provider level is a main driver in Hispanic disenfranchisement from CGM. With a severe shortage of endocrinologists, primary care providers are increasingly managing T1D although many report inadequate confidence in titrating insulin and using CGM. With limited access to endocrinology, low-income, Hispanic adults with T1D thus often receive diabetes management in FQHCs with scant or no access to CGM. Hence, to foster equitable uptake of CGM in the most vulnerable adults with T1D, a 4-year, mixed-methods, feasibility study with a pilot randomized controlled trial (RCT) is underway to primarily assess the feasibility of the SEM-guided, 6-month intervention (targeting the individual, family/social networks, and healthcare provider levels). The SEM-guided intervention was refined by our Community Advisory Board. Refinements were informed by qualitative research exploring SDOH barriers to CGM uptake in low-income adults with T1D from the perspectives of four stakeholder groups.
The individual level of the intervention, guided by the Information-Motivation-Behavioral-Skills Model, fosters essential acquisition of information, motivation, and behavioral skills for CGM uptake through two principal approaches: (1) 4-week, personalized, CGM sessions with a RN/ certified diabetes care and education specialist (CDCES); and (2) subsequent virtual peer educator-led support groups, integrating CGM education, through study month six. The family/social networks level leverages social support to promote critical support in CGM uptake with a family member co-attending the 4-week sessions and participant engagement in peer-led support group sessions, respectively. The provider level of the intervention is designed to promote enhanced cultural competency in intervention delivery and provide clinical support for CGM informed by rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes).
A total of 11 FQHC sites were randomized to deliver the intervention (n=6) or control (n=5) conditions with a total enrollment goal of 30 low-income adults with T1D (sites having roughly equivalent enrollment rates). The feasibility of the study protocol (e.g., recruitment and retention yields, data collection procedures, intervention implementation, and intervention acceptability, among others) will be routinely assessed. Significant intervention signals in terms of physiological (e.g., A1C and time within, above, and below range glucose range), psychosocial (e.g., quality of life and family support), and behavioral (CGM adherence) outcomes from baseline to 3- and 6-months post-baseline will be assessed. The long-term goal of this study is to inform a large, multi-site RCT, and with successful results, provide a model for CGM uptake in low-income adults with T1D for FQHCs nationally
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a mixed-methods, pragmatic pilot RCT design. Mixed-methods will be used to assess study feasibility and acceptability while quantitative methods will be used to assess RCT outcomes. As a pragmatic trial, the intervention (except peer-led support sessions) and control conditions are embedded in routine FQHC diabetes care in the participating sites.
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Intervention Arm | Experimental | Device: CGM InterventionThe intervention arm comprises participants receiving care from FQHC sites randomized to deliver the intervention. This arm will receive the 6-month, SEM-informed intervention to promote CGM uptake and maintenance. |
| Self-Monitoring of Blood Glucose (SMBG) Arm | Other | Other: SMBG Control ConditionThe SMBG control arm comprises participants receiving care from FQHC sites randomized to deliver the control condition. This arm will receive the 6-month control condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Low-income status
- Documented diagnosis of T1D
- 18 years of age or older
- Federally Qualified Health Center (FQHC) primary care provider
- English or Spanish-speaking And at intervention sites
Key exclusion criteria (6 listed)
- Pregnancy or planning to become pregnant
- Lactation
- Serious illness that may prevent study participation (e.g., severe depression)
- Less than 6 months life expectancy
- Alcohol abuse or dependence
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 |
|---|---|---|
| CGM InterventionThe intervention has 4 components with CGM uptake and maintenance as a primary focus. (1) Participants will visit their primary care provider (PCP) at baseline and 3- and 6-months post-baseline (or more frequently as needed) for review of CGM data and insulin therapy adjustments as indicated. Intervention providers received rigorous training in T1D management and CGM via Project ECHO (Extension for Community Healthcare Outcomes). (2) After each PCP visit, the CDCES will follow-up with participants to ensure participant understanding of the education/instructions provided at the PCP visit. (3) Next, participants will receive 4-weekly sessions of culturally sensitive, intensive CGM education and training led by a CDCES with accompaniment of a supportive family member or friend. (4) Virtual group support sessions, led by a peer educator, will follow over 5 months. During this period, the peer-led sessions will take place every two weeks and then move to every three weeks. | Device | Continuous Glucose Monitoring (CGM) Intervention Arm |
| SMBG Control ConditionThe SMBG control condition consists of 3 components delivered over 6 months. (1) Participants will visit their PCP at baseline and 3- and 6-months post-baseline (or more frequently as needed) for review of SMBG data and insulin therapy adjustments as indicated. Control providers received rigorous training in T1D management via Project ECHO. (2) Commencing after the first PCP visit, participants will have 4-weekly telehealth visits for knowledge and skills reinforcement for SMBG. (3) CDCES support phone calls will follow over 5 months. During this period, the support phone calls will take place every two weeks and then move to every three weeks. | Other | Self-Monitoring of Blood Glucose (SMBG) Arm |
Primary outcome
Number of days CGM worn
Time frame: 3 months and 6 months
The total number of days CGM worn. Data will be collected from Ambulatory Glucose Profile Reports.
Percentage of time the CGM is active
Time frame: 3 months and 6 months
The percentage of time the CGM is active. Data will be collected from Ambulatory Glucose Profile Reports.
11 secondary outcomes
A1C
Time frame: Baseline, 3 months, and 6 months
CGM time in range (TIR)
Time frame: 3 months and 6 months
CGM time below range (TBR)
Time frame: 3 months and 6 months
CGM time above range (TAR)
Time frame: 3 months and 6 months
Number of hypoglycemic-related emergency department (ED) visits over past 3 months
Time frame: Baseline, 3 months, and 6 months
Number of hypoglycemic-related hospitalizations
Time frame: Baseline, 3 months, and 6 months
Number of hyperglycemic-related ED visits
Time frame: Baseline, 3 months, and 6 months
Number of hyperglycemic-related hospitalizations
Time frame: Baseline, 3 months, and 6 months
Medical Outcomes Survey Short Form-36
Time frame: Baseline, 3 months, and 6 months
Multidimensional Scale of Perceived Social Support
Time frame: Baseline, 3 months, and 6 months
Interpersonal Processes of Care Survey: Short Form
Time frame: Baseline, 3 months, and 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 12 Aug 2025.
- Derived from this study: PubMed 42228938Newlin-Lew K, Perez-Brescia M, Channamsetty V, Salas-Vega M, Krol M, Jacque F, Lippman C, Allen NA. Continuous Glucose Monitoring Intervention for Hispanic Adults With Type 1 Diabetes Receiving Care in a Federally Qualified Health Center: Protocol for a Mixed Methods, Pragmatic Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 2;15:e60583. doi: 10.2196/60583.
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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.
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 CGM Intervention in people with Type 1 Diabetes, run by University of Connecticut 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 8 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: enrolling by invitation, as of the sponsor's last update on 12 Aug 2025. 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?
Number of days CGM worn (time frame: 3 months and 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?
On the ClinicalTrials.gov record for NCT06487962, which also lists 1 linked publication.
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 12 Aug 2025.