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Brief Summary

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.

Outcome Measures

Primary Outcomes (1)

Glycemic control as measured by Hemoglobin A1c (HbA1c)
A reduction in Hemoglobin A1C is being studied. With the current sample size, we expect a reduction in Hemoglobin A1C level by 0.5 as compared to the POC glucose monitoring arm to be significant after 12 weeks.
From enrollment to end of monitoring at 12 weeks

Secondary Outcomes (3)

Hospital readmissions over 12 weeks
12 weeks
Diabetes related readmissions at 12 weeks
12 weeks
Hypoglycemic events as measured by low glucose reading and symptoms as described by patients at follow up
12 weeks

Study Arms (2)

Participants discharged with continuous glucose monitoring

ACTIVE COMPARATOR

Participants discharged with usual care with point-of-care (POC) capillary glucose per standard of care

Device: Continuous glucose monitor

Participants discharged with usual care with point-of-care (POC) capillary glucose checks

NO INTERVENTION

Participants are discharged with point of care glucose checks with routine glucometer, lancets etc. to check their blood glucose levels as prescribed by their provider

Interventions

Continuous glucose monitorDevice

Participants in the intervention arm will be educated and discharged from their hospitalization with a continuous glucose monitor and followed up in clinic.

Also known as: CGM

Participants discharged with continuous glucose monitoring

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Arunab H Mehta, MD, MEdCONTACT3129343095 mehtaab@ucmail.uc.edu

Lexi Harrison, BSCONTACTharrislx@mail.uc.edu

Arunab H Mehta, MD, MEDPRINCIPAL INVESTIGATOR

Houman Varghai, MDPRINCIPAL INVESTIGATOR

Mercedes Falciglia, MDSUB INVESTIGATOR

Related Publications (1)

Umpierrez GE, Castro-Revoredo I, Moazzami B, Nayberg I, Zabala Z, Galindo RJ, Vellanki P, Peng L, Klonoff DC. Randomized Study Comparing Continuous Glucose Monitoring and Capillary Glucose Testing in Patients With Type 2 Diabetes After Hospital Discharge. Endocr Pract. 2025 Mar;31(3):286-291. doi: 10.1016/j.eprac.2024.11.018. Epub 2024 Dec 17.

PMID: 39694328BACKGROUND

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Model Details: Prospective, parallel-group, randomized, intention-to-treat clinical trial

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Associate Professor of Medicine

Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Participants discharged with continuous glucose monitoring

Participants discharged with usual care with point-of-care (POC) capillary glucose checks

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Participants discharged with continuous glucose monitoring

Participants discharged with usual care with point-of-care (POC) capillary glucose checks

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations