Continuous Glucose Monitoring Following Hospital Discharge

NCT05360056 | Active Not Recruiting Results FDA Device

• 1 other identifier: 2021H0426
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Change in TIR 70-180 mg/dl

  Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.

  12 weeks

• % Wear Time >70%

  The number of participants with % wear time \>70% will be reported.

  12 weeks

• DTSQc Score

  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

Study Arms (1)

Dexcom CGM

EXPERIMENTAL

Device: DexCom G6

Interventions

DexCom G6 DEVICE

Wearable continuous glucose monitor

Dexcom CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes
• Basal insulin use \>10 units per day
• Hemoglobin A1c \>8.0%
• Smartphone compatible with Clarity App
• Age ≥18 years

You may not qualify if:

• Type 1 DM
• Inability to consent
• Pregnancy
• Prisoners
• Discharge to skilled nursing facility

Sponsors & Collaborators

• Kathleen Dungan: lead
• DexCom, Inc.: collaborator

Study Sites (1)

The Ohio State University Medical Center - Outpatient Care East

Columbus, Ohio, 43203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Kathleen Dungan
• Organization: The Ohio State University

kathleen.dungan@osumc.edu

6146853333

Study Officials

• Kathleen Dungan, MD

  OSU Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 4, 2022
• Study Start: April 26, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 29, 2026
• Results First Posted: December 9, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)