Continuous Glucose Monitoring Following Hospital Discharge

Type 2 Diabetes Clinical Trial

Official title:

Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05360056
• Other study ID #: 2021H0426
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• DexCom G6
Wearable continuous glucose monitor

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center - Outpatient Care East	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Dungan	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in TIR 70-180 mg/dl		12 weeks
Primary	The proportion of patients with % wear time >70% will be reported.	The proportion of patients with % wear time >70% will be reported.	12 weeks
Primary	Change in DTSQc scores	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.	12 weeks