Continuous Glucose Monitoring for Type 2 Diabetes

(TRANSITION-CGM Trial)

AH
LH
Overseen ByLexi Harrison, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The TRANSITION-CGM trial will evaluate whether starting continuous glucose monitoring (CGM) before hospital discharge improves blood glucose control in adults with type 2 diabetes compared with usual care using finger-stick blood glucose checks. The study focuses on the transition from hospital to home, when patients may face changes in diabetes medications and challenges managing their blood glucose levels.

This single-center, randomized controlled trial will enroll approximately 218 adults with type 2 diabetes, a hemoglobin A1c (HbA1c) 9% and above, and treatment with insulin and/or oral diabetes medications. Participants will be recruited during hospitalization and must be expected to return home after discharge. People already using a CGM will not be eligible.

Participants will be randomly assigned in equal numbers to one of two groups. The CGM group will start using a continuous glucose monitor before discharge and receive device training and written instructions. The usual-care group will continue finger-stick blood glucose monitoring and receive standard discharge education. Both groups will receive assistance with outpatient diabetes follow-up. Diabetes medications will be managed by treating clinicians according to usual clinical practice.

Participants will be followed for approximately 12 weeks after discharge, with an early follow-up encounter and a final assessment at 12 weeks. The primary outcome is HbA1c at 12 weeks, a blood test that reflects average blood glucose levels over approximately three months. Secondary outcomes include diabetes-related hospitalizations and episodes of low blood sugar. Additional exploratory measures include CGM use, follow-up attendance, patient-reported experiences, and time spent within the target glucose range when CGM data are available.

The study will determine whether initiating CGM during hospitalization can improve glycemic control after discharge and provide preliminary evidence about its effects on diabetes-related hospitalizations and hypoglycemia.

Who Is on the Research Team?

MF

Mercedes Falciglia, MD

Principal Investigator

University of Cincinnati

AH

Arunab H Mehta, MD, MEd

Principal Investigator

University of Cincinnati

HV

Houman Varghai, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are in the hospital, have an HbA1c of 9% or higher, and are treated with insulin or oral diabetes medications. Participants must not already use a continuous glucose monitor and should be expected to go home after discharge.

Inclusion Criteria

HbA1C ≥ 9%
Anticipated discharge to home within 48-72 hours
Ability to provide informed consent and attend 12-week follow-up
See 3 more

Exclusion Criteria

Hemoglobin A1C less than 9%
I do not have a psychiatric illness that prevents me from understanding or following the study.
I have end-stage kidney disease.
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous glucose monitor

Trial Overview

The study compares starting a continuous glucose monitor (CGM) before leaving the hospital versus usual care using finger-stick blood sugar checks. Patients are randomly assigned to either group and followed for about 12 weeks after going home.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Participants discharged with continuous glucose monitoringActive Control1 Intervention
Group II: Participants discharged with usual care with point-of-care (POC) capillary glucose checksActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+