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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Mean Illness Intrusiveness Ratings Scale score (IIRS) [Time frame: Baseline, 12 weeks, 24 weeks]
• Mean Hemoglobin A1c concentration [Time frame: Baseline, 12 weeks, 24 weeks]

Secondary outcome measures (6)

• Mean Treatment Burden Questionnaire (TBQ) score [Time frame: Baseline, 12 weeks, 24 weeks]
• Mean Diabetes Distress Scale score (DDS-17) [Time frame: Baseline, 12 weeks, 24 weeks]
• Mean Summary of Diabetes Self-Care Activities (SDSCA) score [Time frame: Baseline, 12 weeks, 24 weeks]
• Score on digital supplement to TBQ (TBQ+D) [Time frame: Baseline, 12 weeks, 24 weeks]
• Quality of life analogue scale [Time frame: Baseline, 12 weeks, 24 weeks]
• TBQ+D Cognitive Interview tool [Time frame: Baseline, 12 weeks, 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Fair Haven Community Health Care (FHCHC) — New Haven

Identifiers

NCT: NCT06658067 · 2000038335

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗