RECRUITING

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

Conditions

Diabetes Type 2 Diabetes Type 2 Diabetes Mellitus - Poor Control

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CGMs for All: Studying the Impact of Expanding CGM Access

Quick Facts

Study Start:2024-11-12

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06658067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Justin A Dower, MD

CONTACT

(973) 901-4431

justin.dower@yale.edu

Anne Camp, MD

CONTACT

(203) 927-6666

a.camp@fhchc.org

Principal Investigator

Kasia Lipska, MD MHS

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Fair Haven Community Health Care (FHCHC)

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Kasia Lipska, MD MHS, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-11-12

Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

Diabetes
Type 2 Diabetes
Type 2 Diabetes Mellitus - Poor Control