Diabetes Management Using Continuous Glucose Monitors and Remote Patient Monitoring in Underserved Populations

NCT06939413 | Recruiting DMC FDA Device

• 1 other identifier: IIS-2024-172
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this 52 week prospective study is to learn whether a Diabetes Care Management Program using a continuous glucose monitor (CGM) and remotely monitoring (RPM) glucose readings can help improve glucose levels and diabetes related distress in individuals with uncontrolled type 2 diabetes. The CGM and RPM are used as an adjunct to usual care. The main questions it aims to answer are: Does use of CGM \& RPM improve A1c? Does use of CGM \& RPM improve the percent of time spent with glucose levels between 70-180 mg/dl? Does the diabetes care management program improve diabetes related distress? Participants enrolled in the study will be wearing a CGM. Participants will be able to see the glucose readings from the CGM and see how their glucose level responds to food, physical activity, medications and daily life. The diabetes primary care team will be remotely monitoring the participant's glucose data from the CGM. They will reach out to the participant to make adjustments in treatment regimen as needed. Participants will answer a "Problem Areas in Diabetes"questionnaire that asks questions about diabetes related distress.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Uncontrolled type 2 diabetes mellitus; CGM; Remote patient monitoring

Outcome Measures

Primary Outcomes (3)

• Change in A1c

  A1c is a blood test that measures the average glucose level over the previous 2 to 3 months. A normal A1c is 5.7 to 6.4%. The usual goal for most people with diabetes is \< 7% or as close to normal as possible without low glucose levels

  Baseline, 12, 24, 36 and 52 weeks

• Change in time in range (TIR)

  TIR measures the percentage of glucose values between 70-180 mg/dl ie the percentage of time spent between 70-180 mg/dl . The usual goal for most individuals with diabetes is to have TIR \> 70%

  Baseline, 6, 12, 24, 36 and 52 weeks

• Change in Problem Areas in Diabetes (PAID) score

  PAID is a 20 point questionnaire that assesses diabetes related distress. A lower score indicates less diabetes related distress. A score of \> 40 indicates significant diabetes related distress. Typically the PAID score decreases in response to diabetes care management. An extremely low score (0-10) combined with high glucose levels may be indicative of denial. The score can range from 0 to 125.

  Baseline, 12, 24 and 52 weeks

Secondary Outcomes (5)

• Change in time above range (TAR)

  Assessed at baseline, 6, 12, 24, 36 and 52 weeks

• Change in time below range (TBR)

  Assessed at baseline, 6, 12, 24, 36 and 52 weeks

• Change in Glucose Management Indicator (GMI)

  Assessed at baseline, 6, 12, 24, 36 and 52 weeks

• Patient Satisfaction Survey

  Assessed at 12, 24 and 52 weeks

• Change in Primary care provider (PCP) Satisfaction

  Assessed at baseline , 24 and 52 weeks

Study Arms (1)

Intervention

OTHER

The participants will be in the intervention arm for 24 weeks with an optional 28 week extension . The intervention being studied is continuous glucose monitoring (CGM) and remote patient monitoring that is being provided as an adjunct to usual diabetes care

Device: Continuous glucose monitor (CGM)

Interventions

Continuous glucose monitor (CGM) DEVICE

The glucose data from the CGM will help participants to understand the effect of lifestyle and medications on their glucose levels. The glucose levels from the CGM will be remotely monitored. Outreach will be made to participants not reaching glycemic goals. Appropriate adjustments in treatment regimen will be made based on the glucose data obtained from CGM and RPM

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older with Type 2 diabetes AND
• A1c \> 8%

You may not qualify if:

• Pregnancy (participant-reported)
• Previous real time CGM use for more than 6 weeks in the last 3 months
• Use of steroids
• Active cancer treatment
• Terminal illness
• Dementia, mental impairment
• Type 1 diabetes
• End stage renal disease, on dialysis

Sponsors & Collaborators

• Diabetes Solutions International: lead
• DexCom, Inc.: collaborator
• Tidepool: collaborator
• MAVEN Project: collaborator

Study Sites (1)

Community Health Center of Franklin County

Greenfield, Massachusetts, 01301, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sushma Reddy, MD

  Diabetes Solutions International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sushma Reddy, MD

CONTACT

8103859699; sushreddyendo@yahoo.com

Jill Einstein, MD

CONTACT

4157223638; jeinstein@mavenproject.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm prospective 24-week study with an optional 28 week extension Patients from a clinic site not involved in the study will be used as case matched controls.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)