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Continuous Glucose Monitoring Following Hospital Discharge

Sponsor
Kathleen Dungan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05360056
Collaborator
DexCom, Inc. (Industry)
100
Enrollment
1
Location
1
Arm
22.2
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DexCom G6
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients With Type 2 Diabetes
Actual Study Start Date :
Apr 26, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexcom CGM

Device: DexCom G6
Wearable continuous glucose monitor

Outcome Measures

Primary Outcome Measures

  1. Percent change in TIR 70-180 mg/dl [12 weeks]

  2. The proportion of patients with % wear time >70% will be reported. [12 weeks]

    The proportion of patients with % wear time >70% will be reported.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ohio State University Medical Center - Outpatient Care East Columbus Ohio United States 43203

Sponsors and Collaborators

  • Kathleen Dungan
  • DexCom, Inc.

Investigators

  • Principal Investigator: Kathleen Dungan, MD, OSU Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kathleen Dungan, Professor, Ohio State University
ClinicalTrials.gov Identifier:
NCT05360056
Other Study ID Numbers:
  • 2021H0426
First Posted:
May 4, 2022
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 4, 2022