Continuous Glucose Monitoring Following Hospital Discharge
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DexCom G6
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- The Ohio State University Medical Center - Outpatient Care EastRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dexcom CGM
Arm Description
Outcomes
Primary Outcome Measures
Percent change in TIR 70-180 mg/dl
The proportion of patients with % wear time >70% will be reported.
The proportion of patients with % wear time >70% will be reported.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05360056
First Posted
April 26, 2022
Last Updated
January 18, 2023
Sponsor
Kathleen Dungan
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05360056
Brief Title
Continuous Glucose Monitoring Following Hospital Discharge
Official Title
Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Dungan
Collaborators
DexCom, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexcom CGM
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DexCom G6
Intervention Description
Wearable continuous glucose monitor
Primary Outcome Measure Information:
Title
Percent change in TIR 70-180 mg/dl
Time Frame
12 weeks
Title
The proportion of patients with % wear time >70% will be reported.
Description
The proportion of patients with % wear time >70% will be reported.
Time Frame
12 weeks
Title
Change in DTSQc scores
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trevor Sobol
Phone
(614) 688-6257
Email
trevor.sobol@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Dungan, MD
Organizational Affiliation
OSU Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center - Outpatient Care East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Kalash
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Continuous Glucose Monitoring Following Hospital Discharge
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