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

CGMs for All: Studying the Impact of Expanding CGM Access

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Type 2 Diabetes; Type 2 Diabetes Mellitus - Poor Control
• Intervention / Treatment: Device: Continuous Glucose Monitor (CGM)

Detailed Description

This study will enroll adult patients with type 2 diabetes and A1c of 8.0 or greater despite long-term use of insulin who are underinsured and under-resourced , meaning they are unable to reasonably afford CGM sensors. The participants will be chosen from among the panels of three providers.

This study aims to determine whether providing CGMs free of charge to patients with poorly controlled diabetes who could not otherwise afford them positively impacts their glycemic control and quality of life.

FHCHC's clinicians will identify adult patients from their panel with type 2 diabetes and poor glycemic control (A1c at least 8) on insulin who may be unable to afford CGM. Once consented, participants will have point-of-care A1c testing as well as pregnancy testing (if applicable); patient eligibility based on glycemic control criterion should be determined by this A1c. Participants will then complete the study questionnaires. Clinic staff will teach CGM sensor placement and determine whether a reader is required or if a compatible mobile device for intermittent scanning will be used. Blood Glucose (BG) readings are provided via online Libre portal.

At the 6-week follow-up visit, the provider will recommend adjustments to the participant's medication regimen based on their BG trends on CGM and their clinical judgment. Providers will ask participants to report any adverse events, safety issues, or trouble with the CGM system thus far experienced.

At the 12-week follow-up visit, participants will repeat completion of study questionnaires and undergo second A1c measurement. Further adjustment to medication regimen is permitted as provider sees fit.

At the 24-week follow-up visit, participants will repeat completion of study questionnaires for a third time and undergo third A1c measurement.

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justin A Dower, MD; Phone Number: (973) 901-4431; Email: justin.dower@yale.edu
• Study Contact Backup: Name: Anne Camp, MD; Phone Number: (203) 927-6666; Email: a.camp@fhchc.org

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Fair Haven Community Health Care (FHCHC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Poorly Controlled Type 2 Diabetes- CGM; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Treatment Burden Questionnaire (TBQ) score	The TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem), to 10 (big problem). Item scores can be summed into a total score, ranging from 0 to 130. Higher scores indicate higher burden.	Baseline, 12 weeks, 24 weeks
Mean Summary of Diabetes Self-Care Activities (SDSCA) score	The SDSCA is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.Total score range is 7-70. Higher scores indicate more days spent doing diabetes self-care activities (such as checking blood sugar, following a diet plan, and participating in exercise activities).	Baseline, 12 weeks, 24 weeks
Score on digital supplement to TBQ (TBQ+D)	The TBQ+D adds an additional 6 items to the TBQ, each rated on a Likert scale ranging from 0 (not a problem) to 10 (big problem). Item scores can be summed into a total score, ranging from 0 to 60. Higher scores indicate higher burden incurred by the use of digital health devices.	Baseline, 12 weeks, 24 weeks
Quality of life analogue scale	This scale asks respondents to rate how diabetes has affected their quality of life over the last 2 weeks on a scale from 0 (the worst it has ever been) to 10 (the best it has ever been). Higher scores indicate better perceived quality of life.	Baseline, 12 weeks, 24 weeks
TBQ+D Cognitive Interview tool	Cognitive Interview Tool: 10 participants will be asked to complete the TBQ+D survey aloud and provide their thoughts about the questions included. These recordings will be transcribed and evaluated qualitatively for recurrent themes.	Baseline, 12 weeks, 24 weeks
Mean Diabetes Distress Scale score (DDS-17)	DDS-17 is a 17-item measure that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) concerning distress experienced over the last month. Total score range from 1 to 6 with higher scores indicating more distress.	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Yale Office of Global Health
• Investigators: Principal Investigator: Kasia Lipska, MD MHS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2000038335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual study data for the participants completing the Cognitive Interview Tool will be deidentified and shared with collaborators at the Mayo Clinic. Investigators have completed a Data Usage Agreement (DUA) with the Yale Office of Sponsored Projects (OSP).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No