Clinical trial NCT05911256: A Community Health Worker/Pharmacist Team to Improve Blood Sugars in Diabetes Care Using Continuous Glucose Monitoring
Official title: TEAM Support to Improve Glycemic Control Using CGM in Diverse Populations
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Baystate Health
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-20
Enrollment: 318
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 25-75.
* History of T2DM \> 1 year.
* Speak English or Spanish.
* A1c ≥ 9% (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.

Exclusion Criteria:

* 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.).
* 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.

Primary outcomes:
measure: Change in participant HbA1c values
timeFrame: 0, 3, 6, 9, and 12 months (and additional 18-month collection in first 75% of participants)
Secondary outcomes:
measure: Change in glycemic control from baseline using Percent Time in Range
timeFrame: 0, 6, and 12 months
measure: Change in Participant self-reported health-related quality of life from baseline
timeFrame: 0, 6, and 12 months
measure: Change in participant reported Diabetes Self-Management from baseline
timeFrame: 0, 6, and 12 months
measure: Changes in participant reported Diabetes Distress from baseline
timeFrame: 0, 6, and 12 months
measure: Change in participant-reported diabetes treatment burden from baseline
timeFrame: 0, 6, and 12 months
measure: Frequency of participant Healthcare Utilization
timeFrame: 0, 6, and 12 months
measure: Change in mean glycemic control from baseline
timeFrame: 0,6,12 months
measure: Hyperglycemia event rate
timeFrame: 0, 6, 12 months
measure: Change in Glycemic variability from baseline
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Ben Gerber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: