Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06658067
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitors (CGMs) for All: Studying the Impact of Expanding CGM Access
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
CGMs for All: Studying the Impact of Expanding CGM Access
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: