Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access

NCT06658067 | Recruiting FDA Device

• 1 other identifier: 2000038335
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Type 2 Diabetes; Type 2 Diabetes Mellitus - Poor Control

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline, 12 weeks, 24 weeks

• Mean Hemoglobin A1c concentration

  Mean A1c concentration in mg/dL measured in blood samples

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (6)

• Mean Treatment Burden Questionnaire (TBQ) score

  Baseline, 12 weeks, 24 weeks

• Mean Diabetes Distress Scale score (DDS-17)

  Baseline, 12 weeks, 24 weeks

• Mean Summary of Diabetes Self-Care Activities (SDSCA) score

  Baseline, 12 weeks, 24 weeks

• Score on digital supplement to TBQ (TBQ+D)

  Baseline, 12 weeks, 24 weeks

• Quality of life analogue scale

  Baseline, 12 weeks, 24 weeks

Study Arms (1)

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.

Device: Continuous Glucose Monitor (CGM)

Interventions

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.

Poorly Controlled Type 2 Diabetes- CGM

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Yale Office of Global Health: collaborator

Study Sites (1)

Fair Haven Community Health Care (FHCHC)

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Kasia Lipska, MD MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin A Dower, MD

CONTACT

(973) 901-4431; justin.dower@yale.edu

Anne Camp, MD

CONTACT

(203) 927-6666; a.camp@fhchc.org

Study Design

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

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)