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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06658067
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Mean Illness Intrusiveness Ratings Scale score (IIRS) [ Time Frame: Baseline, 12 weeks, 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fair Haven Community Health Care (FHCHC)New HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Fair Haven Community Health Care (FHCHC)· New Haven, CT

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