- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05360056
Continuous Glucose Monitoring Following Hospital Discharge
July 1, 2026 updated by: Kathleen Dungan
Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients With Type 2 Diabetes
In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge.
Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study.
CGM data will be captured by the patient smartphone app and analyzed.
Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia.
Customized reports/ decision support will be sent to the usual diabetes provider.
The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43203
- The Ohio State University Medical Center - Outpatient Care East
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Type 2 Diabetes
- Basal insulin use >10 units per day
- Hemoglobin A1c >8.0%
- Smartphone compatible with Clarity App
- Age ≥18 years
Exclusion Criteria:
- Type 1 DM
- Inability to consent
- Pregnancy
- Prisoners
- Discharge to skilled nursing facility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dexcom CGM
|
Wearable continuous glucose monitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in TIR 70-180 mg/dl
Time Frame: 12 weeks
|
Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.
|
12 weeks
|
|
% Wear Time >70%
Time Frame: 12 weeks
|
The number of participants with % wear time >70% will be reported.
|
12 weeks
|
|
DTSQc Score
Time Frame: 12 weeks
|
The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study.
Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change.
Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction.
The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Dungan, MD, OSU Medical Center
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 Major Dates
Study Start (Actual)
April 26, 2022
Primary Completion (Actual)
August 31, 2024
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
April 26, 2022
First Submitted That Met QC Criteria
May 3, 2022
First Posted (Actual)
May 4, 2022
Study Record Updates
Last Update Posted (Actual)
July 21, 2026
Last Update Submitted That Met QC Criteria
July 1, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021H0426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
• Availability of data and materials: In accordance with institution policy on sharing data and research resources, the final research data from this study may be made available for research purposes under a limited data use agreement specifying criteria for data access, conditions for research use, privacy and confidentiality standards to ensure data security and prohibitions for manipulating data for the purposes of identifying subjects.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.