Continuous Glucose Monitoring Following Hospital Discharge

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Device: DexCom G6

• Registration Number: NCT05360056
• Lead Sponsor: Kathleen Dungan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-26
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-04
• Status Verified: 2024-03
• Primary Completion: 2024-08-31
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexcom CGM	DexCom G6	-

Primary Outcome Measures

Name	Time	Method
Percent change in TIR 70-180 mg/dl	12 weeks
The proportion of patients with % wear time >70% will be reported.	12 weeks	The proportion of patients with % wear time \>70% will be reported.
Change in DTSQc scores	12 weeks	The Diabetes Treatment Satisfaction Questionnaire (change) will be administered at enrollment and at 12 weeks. Total scores will be compared. 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.

Trial Locations

Locations (1)

The Ohio State University Medical Center - Outpatient Care East; 🇺🇸 Columbus, Ohio, United States