Continuous Glucose Monitoring Following Hospital Discharge

NCT ID: NCT05360056

Last Updated: 2025-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-26

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexcom CGM

Group Type EXPERIMENTAL

DexCom G6

Intervention Type DEVICE

Wearable continuous glucose monitor

Interventions

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DexCom G6

Wearable continuous glucose monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

Kathleen Dungan

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Dungan

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kathleen Dungan, MD

Role: PRINCIPAL_INVESTIGATOR

OSU Medical Center

Locations

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The Ohio State University Medical Center - Outpatient Care East

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2021H0426

Identifier Type: -

Identifier Source: org_study_id

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