Clinical trial NCT06658067: Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access
Official title: CGMs for All: Studying the Impact of Expanding CGM Access
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Type 2 Diabetes
Type 2 Diabetes Mellitus - Poor Control
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Yale Office of Global Health
First posted: 2024-10-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Illness Intrusiveness Ratings Scale score (IIRS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Mean Hemoglobin A1c concentration
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Mean Treatment Burden Questionnaire (TBQ) score
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Mean Diabetes Distress Scale score (DDS-17)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Mean Summary of Diabetes Self-Care Activities (SDSCA) score
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Score on digital supplement to TBQ (TBQ+D)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Quality of life analogue scale
timeFrame: Baseline, 12 weeks, 24 weeks
measure: TBQ+D Cognitive Interview tool
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Fair Haven Community Health Care (FHCHC)
state: Connecticut
Study officials:
affiliation: Yale University
name: Kasia Lipska, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: