Recruiting

Continuous Glucose Monitors

Sponsor:

Yale University

Code:

NCT06658067

Conditions

Diabetes

Type 2 Diabetes

Type 2 Diabetes Mellitus - Poor Control

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor (CGM)

Study Details

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

Study ID

NCT06658067

Start date

Nov 12, 2024

Status verified date

Dec, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Fair Haven Community Health Care (FHCHC)

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-12-03.