Type 2 DiabetesTEAM-CGMNCT05911256
A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring
A study testing Pharmacist Only, Continuous Glucose Monitor (CGM) and Community Health Worker (CHW) in people with Type 2 Diabetes, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Continuous glucose monitoring (CGM) can help improve blood sugar management in type 2 diabetes. A sequential, multiple assignment, randomized trial will evaluate clinical pharmacists, community health workers, and telehealth in supporting CGM use to improve blood sugar control. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pharmacist Only, Continuous Glucose Monitor (CGM) and Community Health Worker (CHW)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to Mar 2028
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-75.
- History of T2DM > 1 year.
- Speak English or Spanish.
- A1c ≥ 8% (within past 6 months) - with reduction if necessary based on recruitment.
- eGFR (estimated glomerular filtration rate) > 30.
- Willingness to use continuous glucose monitoring (CGM) and work with a community health worker (including home visits) and clinical pharmacist.
Who cannot join
- Plans for weight reduction surgery or prescription weight loss medication (specific for weight loss, not GLP-1).
- Current, recent, or planned use of CGM.
- Current use of steroids.
- Abuse of illicit drugs.
- Pregnancy (or planned pregnancy).
- Specific comorbidities (e.g., recent MI, TIA, CVA, malignancy, hemoglobinopathy, severe hypoglycemia, etc.).
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- Psychiatric disorder that may limit ability to perform study tasks
- Skin changes that preclude use of sensor or allergy to adhesive.
- Planning to leave geographic area within 12 months or distance from clinical site > 20 miles.
- Participation in another study.
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
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: TEAM Support to Improve Glycemic Control Using CGM in Diverse Populations
Continuous glucose monitoring (CGM) can help improve blood sugar management in type 2 diabetes. A sequential, multiple assignment, randomized trial will evaluate clinical pharmacists, community health workers, and telehealth in supporting CGM use to improve blood sugar control.
Read the detailed description
Continuous glucose monitoring (CGM) has demonstrable benefits for people living with diabetes, including improvement in diabetes control and reduction in hypoglycemia. Randomized controlled trials have demonstrated that CGM can reduce hemoglobin A1c (HbA1c) and increase in the time in range metric. Little is known about CGM use in the broader population with type 2 diabetes (T2DM) in low-income, minority populations not receiving insulin therapy. This proposed study will rigorously evaluate CGM in a diverse and vulnerable population with T2DM in the primary care setting. The proposed study will integrate CGM into the study team's previously studied approach of mobile health (mHealth) diabetes management. The investigators prior research has leveraged mHealth tools and a community health worker (CHW)/clinical pharmacist team to manage low-income, minority populations with T2DM. Clinical pharmacists embedded in the healthcare system review patient glucose levels, promote medication adherence and collaboratively adjust therapy to help patients reach HbA1c goals. CHWs augment pharmacist-led efforts and address social determinants of health and provide individualized, contextual self-management support. In partnership with Baystate Community Health Centers and UMass Memorial Health, the investigators propose an effectiveness study of team-supported CGM using a Sequential Multiple Assignment Randomized Trial (SMART) study design. The investigators plan to study a diverse population with 318 T2DM patients receiving pharmacist- and CHW-supported CGM delivered through community health centers in Massachusetts. The Specific Aims include: (1) Conduct a randomized, controlled trial to evaluate the effectiveness of pharmacist-supported CGM in a diverse patient population with T2DM in the primary care setting. The investigators hypothesize that pharmacist-supported CGM will result in improved HbA1c, CGM metrics, and other secondary outcomes (e.g., quality of life) at 6 months compared with pharmacist-only care; (2) Re-randomize patients not at HbA1c goal after 6 months to receive or not receive CHW support beyond pharmacist-supported CGM. The investigators hypothesize that adding CHWs will result in improved HbA1c, CGM metrics, and other secondary outcomes at 12 months compared with pharmacist-supported CGM alone; (3) Evaluate reach, effectiveness, adoption, implementation, and maintenance using the RE-AIM framework; and (4) Determine total cost and cost-effectiveness of CGM and the supportive components (e.g., clinical pharmacist and CHW) from the perspective of the healthcare organization. If this team support model of diabetes care is found to be cost-effective, such evidence may influence insurance restrictions on ambulatory CGM coverage in T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Pharmacist Only, Continuous Glucose Monitor (CGM), Community Health Worker (CHW)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist OnlyBehavioural
Clinical pharmacists conduct encounters with patients by videoconferencing or phone. Pharmacists conduct a broad range of activities including ongoing evaluation of medication and lifestyle adherence, setting therapeutic goals, formulating a provider-approved plan of care, and documenting the plan in the electronic health record. Pharmacists propose medication changes based on algorithms and protocols derived from national guidelines under physician guidance.
Continuous Glucose Monitor (CGM)Device
Patients will receive the Continuous Glucose Monitoring (CGM) system. The instruction on use of device is the intervention being tested, not the effectiveness of the device itself. Participants will receive instruction and training on how to use the device and will wear the device for 10 days.
Community Health Worker (CHW)Behavioural
Patients are connected to a community health worker (CHW). CHWs conduct telehealth or home visits and facilitate 3-way Telehealth visits (Patients, pharmacists, and CHWs) via an iPad with cellular plan. Additional CHW activities include social determinants of health screening, health behavior education, problem solving, goal setting, and medication adherence support.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Only | Active comparator | Participants will receive clinical pharmacist management of diabetes. Those participants who meet their HbA1c goal at 6 months will continue with maintenance diabetes management. This includes routine primary care with the primary care provider, routine medication management, and traditional home glucose monitoring. For those not meeting goals in HbA1c they will be randomized again to receive Pharmacist + CGM or receive Pharmacist + CGM + Community Health Worker (CHW) support. Receives: Behavioral: Pharmacist Only |
| Pharmacist + CGM | Experimental | Participants receive clinical pharmacist + CGM support. Those participants who meet their HbA1c goal at 6-months will continue with maintenance diabetes management. This includes routine primary care with the primary care provider, routine medication management, and traditional home glucose monitoring. For those not meeting goals in HbA1c, they will be randomized again to continue with pharmacist + CGM or receive additional CHW support (Pharmacist + CGM + CHW). Receives: Behavioral: Pharmacist Only; Device: Continuous Glucose Monitor (CGM) |
| Pharmacist + CGM + CHW | Experimental | A second randomization step occurs at 6-months. Participants randomized to this condition receive clinical pharmacist, CHW, and CGM support. Receives: Behavioral: Pharmacist Only; Device: Continuous Glucose Monitor (CGM); Behavioral: Community Health Worker (CHW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant HbA1c values
Participant HbA1c will be measured and obtained by finger stick using home testing kits.
Measured: 0, 3, 6, 9, and 12 months (and additional 18-month collection in first 75% of participants)
Secondary outcomes (9)
Change in glycemic control from baseline using Percent Time in Range
The percentage of time when blood glucose was between 70 and 180 mg/dl, percentage of time when blood glucose was greater than 250mg/dL , and percentage of time when glucose was les than 70mg/dL. as measured by the continuous glucose monitor
Measured: 0, 6, and 12 months
Change in Participant self-reported health-related quality of life from baseline
Participant self-reported health related quality of life will be measured using EQ-5D (not an abbreviation), a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health. 1)Mobility, 2)Self-Care 3) Usual Activities 4)Pain and Discomfort 5)Anxiety and Depression. 'Scores for each dimension range from 1-3 with higher scores indicating lower quality/worse outcomes
Measured: 0, 6, and 12 months
Change in participant reported Diabetes Self-Management from baseline
Diabetes Self-Management will be measured using Diabetes Self-Management Questionnaire (DSMQ) is a 16 item questionnaire use to assess self-care activities associated with glycemic control. Scores range from 0 to 10 with higher scores associated with poorer diabetes self-management.
Measured: 0, 6, and 12 months
Changes in participant reported Diabetes Distress from baseline
Participant reported Diabetes Distress will be measured using the Diabetes Distress Scale (DDS) is a 17 -item scale that captures you critical dimensions of distress for individuals with Diabetes: emotional burden, regimen distress, interpersonal distress, and physician distress. The DDS results in an overall distress score ranging from 1 to 6 with higher scores indicating greater distress. The DDS also yields 4 sub scale scores for each 4 dimensions of distress with scores ranging from 1 to 6, with higher scores indicating greater distress.
Measured: 0, 6, and 12 months
Change in participant-reported diabetes treatment burden from baseline
Participant reported diabetes treatment burden will be assessed using the Diabetes Treatment Burden Questionnaire(DTBQ). The DTBQ is an 18-item questionnaire that assesses the treatment burden caused by pharmacotherapy for type 2 diabetes. Scores range from 0 to 6 with 0 corresponding to minimum burden, and 6 corresponding to maximum burden.
Measured: 0, 6, and 12 months
Frequency of participant Healthcare Utilization
Participant Healthcare utilization will be measured with a 3-question survey to capture the frequency of Emergency Room visits, calls to 911, after hours/urgent care visits, and dietician visits. This survey includes encounters whether diabetes-related or not.
Measured: 0, 6, and 12 months
Change in mean glycemic control from baseline
Mean glucose as measured by the continuous glucose monitor
Measured: 0,6,12 months
Hyperglycemia event rate
Number of hyperglycemic events as measured by the continuous glucose monitor
Measured: 0, 6, 12 months
Change in Glycemic variability from baseline
This will be measured by the continuous glucose monitor, the coefficient of variation in glucose variability will be reported.
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start27 Sep 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Baystate Health, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Ben Gerber, University of Massachusetts, Worcester
- Investigators
- Ben Gerber, MD, MPH, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911256
- Sponsor's protocol ID
- STUDY00000848
- Other IDs
- R01DK133265
- Acronym
- TEAM-CGM
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant survey data, participant physiologic data, community health worker training and protocol, clinical pharmacist training and protocol, will be shared. This includes a complete, de-identified data set, including survey and clinical/physiologic data (and relevant R or SAS code) through DKnet, the Inter-University Consortium for Political and Social Research, or eScholarship@UMassChan.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAM Support to Improve Glycemic Control Using CGM in Diverse Populations
- ClinicalTrials.gov ID
- NCT05911256
- Acronym / sponsor ID
- TEAM-CGM / STUDY00000848
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Baystate Health, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Jun 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.
Continuous glucose monitoring (CGM) can help improve blood sugar management in type 2 diabetes. A sequential, multiple assignment, randomized trial will evaluate clinical pharmacists, community health workers, and telehealth in supporting CGM use to improve blood sugar control.
Detailed description
Continuous glucose monitoring (CGM) has demonstrable benefits for people living with diabetes, including improvement in diabetes control and reduction in hypoglycemia. Randomized controlled trials have demonstrated that CGM can reduce hemoglobin A1c (HbA1c) and increase in the time in range metric. Little is known about CGM use in the broader population with type 2 diabetes (T2DM) in low-income, minority populations not receiving insulin therapy. This proposed study will rigorously evaluate CGM in a diverse and vulnerable population with T2DM in the primary care setting. The proposed study will integrate CGM into the study team's previously studied approach of mobile health (mHealth) diabetes management. The investigators prior research has leveraged mHealth tools and a community health worker (CHW)/clinical pharmacist team to manage low-income, minority populations with T2DM. Clinical pharmacists embedded in the healthcare system review patient glucose levels, promote medication adherence and collaboratively adjust therapy to help patients reach HbA1c goals. CHWs augment pharmacist-led efforts and address social determinants of health and provide individualized, contextual self-management support. In partnership with Baystate Community Health Centers and UMass Memorial Health, the investigators propose an effectiveness study of team-supported CGM using a Sequential Multiple Assignment Randomized Trial (SMART) study design. The investigators plan to study a diverse population with 318 T2DM patients receiving pharmacist- and CHW-supported CGM delivered through community health centers in Massachusetts. The Specific Aims include: (1) Conduct a randomized, controlled trial to evaluate the effectiveness of pharmacist-supported CGM in a diverse patient population with T2DM in the primary care setting. The investigators hypothesize that pharmacist-supported CGM will result in improved HbA1c, CGM metrics, and other secondary outcomes (e.g., quality of life) at 6 months compared with pharmacist-only care; (2) Re-randomize patients not at HbA1c goal after 6 months to receive or not receive CHW support beyond pharmacist-supported CGM. The investigators hypothesize that adding CHWs will result in improved HbA1c, CGM metrics, and other secondary outcomes at 12 months compared with pharmacist-supported CGM alone; (3) Evaluate reach, effectiveness, adoption, implementation, and maintenance using the RE-AIM framework; and (4) Determine total cost and cost-effectiveness of CGM and the supportive components (e.g., clinical pharmacist and CHW) from the perspective of the healthcare organization. If this team support model of diabetes care is found to be cost-effective, such evidence may influence insurance restrictions on ambulatory CGM coverage in T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Only | Active comparator | Behavioral: Pharmacist OnlyParticipants will receive clinical pharmacist management of diabetes. Those participants who meet their HbA1c goal at 6 months will continue with maintenance diabetes management. This includes routine primary care with the primary care provider, routine medication management, and traditional home glucose monitoring. For those not meeting goals in HbA1c they will be randomized again to receive Pharmacist + CGM or receive Pharmacist + CGM + Community Health Worker (CHW) support. |
| Pharmacist + CGM | Experimental | Behavioral: Pharmacist Only, Device: Continuous Glucose Monitor (CGM)Participants receive clinical pharmacist + CGM support. Those participants who meet their HbA1c goal at 6-months will continue with maintenance diabetes management. This includes routine primary care with the primary care provider, routine medication management, and traditional home glucose monitoring. For those not meeting goals in HbA1c, they will be randomized again to continue with pharmacist + CGM or receive additional CHW support (Pharmacist + CGM + CHW). |
| Pharmacist + CGM + CHW | Experimental | Behavioral: Pharmacist Only, Device: Continuous Glucose Monitor (CGM), Behavioral: Community Health Worker (CHW)A second randomization step occurs at 6-months. Participants randomized to this condition receive clinical pharmacist, CHW, and CGM support. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 25-75.
- History of T2DM > 1 year.
- Speak English or Spanish.
- A1c ≥ 8% (within past 6 months) - with reduction if necessary based on recruitment.
- eGFR (estimated glomerular filtration rate) > 30.
Key exclusion criteria (10 listed)
- Plans for weight reduction surgery or prescription weight loss medication (specific for weight loss, not GLP-1).
- Current, recent, or planned use of CGM.
- Current use of steroids.
- Abuse of illicit drugs.
- Pregnancy (or planned pregnancy).
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 |
|---|---|---|
| Pharmacist OnlyClinical pharmacists conduct encounters with patients by videoconferencing or phone. Pharmacists conduct a broad range of activities including ongoing evaluation of medication and lifestyle adherence, setting therapeutic goals, formulating a provider-approved plan of care, and documenting the plan in the electronic health record. Pharmacists propose medication changes based on algorithms and protocols derived from national guidelines under physician guidance. | Behavioural | Pharmacist + CGM, Pharmacist + CGM + CHW, Pharmacist Only |
| Continuous Glucose Monitor (CGM)Patients will receive the Continuous Glucose Monitoring (CGM) system. The instruction on use of device is the intervention being tested, not the effectiveness of the device itself. Participants will receive instruction and training on how to use the device and will wear the device for 10 days. | Device | Pharmacist + CGM, Pharmacist + CGM + CHW |
| Community Health Worker (CHW)Patients are connected to a community health worker (CHW). CHWs conduct telehealth or home visits and facilitate 3-way Telehealth visits (Patients, pharmacists, and CHWs) via an iPad with cellular plan. Additional CHW activities include social determinants of health screening, health behavior education, problem solving, goal setting, and medication adherence support. | Behavioural | Pharmacist + CGM + CHW |
Primary outcome
Change in participant HbA1c values
Time frame: 0, 3, 6, 9, and 12 months (and additional 18-month collection in first 75% of participants)
Participant HbA1c will be measured and obtained by finger stick using home testing kits.
9 secondary outcomes
Change in glycemic control from baseline using Percent Time in Range
Time frame: 0, 6, and 12 months
Change in Participant self-reported health-related quality of life from baseline
Time frame: 0, 6, and 12 months
Change in participant reported Diabetes Self-Management from baseline
Time frame: 0, 6, and 12 months
Changes in participant reported Diabetes Distress from baseline
Time frame: 0, 6, and 12 months
Change in participant-reported diabetes treatment burden from baseline
Time frame: 0, 6, and 12 months
Frequency of participant Healthcare Utilization
Time frame: 0, 6, and 12 months
Change in mean glycemic control from baseline
Time frame: 0,6,12 months
Hyperglycemia event rate
Time frame: 0, 6, 12 months
Change in Glycemic variability from baseline
Time frame: 0, 6, 12 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 4 Sep 2026.
- Individual participant dataSharing planned: Yes. Participant survey data, participant physiologic data, community health worker training and protocol, clinical pharmacist training and protocol, will be shared. This includes a complete, de-identified data set, including survey and clinical/physiologic data (and relevant R or SAS code) through DKnet, the Inter-University Consortium for Political and Social Research, or eScholarship@UMassChan.
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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.
Ben Gerber, MD, MPH principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Only, Continuous Glucose Monitor (CGM) and Community Health Worker (CHW) in people with Type 2 Diabetes, run by University of Massachusetts, Worcester 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 6 inclusion and 10 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 4 Sep 2026. 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?
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?
Change in participant HbA1c values (time frame: 0, 3, 6, 9, and 12 months (and additional 18-month collection in first 75% of participants)). 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 4 Sep 2026.