Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer

NCT ID: NCT04938869

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-02-17

Brief Summary

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This clinical trial studies the effect of a continuous glucose monitor application in improving outcomes in patients with poorly controlled type 2 diabetes and active cancer. Patient satisfaction with type 2 diabetes management influences medication-taking behavior as well as health outcomes. Adding continuous glucose monitor application to diabetes treatment plan after hospital discharge plan may improve patient satisfaction and reduce diabetes distress.

Detailed Description

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PRIMARY OBJECTIVE:

I. Evaluate if addition of continuous glucose monitor (CGM) to diabetes treatment plan following inpatient hospitalization is associated with improved patient satisfaction with DM management in patients with cancer and poorly controlled type 2 diabetes mellitus.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of CGM initiation upon hospital discharge. II. Evaluate effect of CGM on recognition of post-hospitalization hypoglycemia. III. Evaluate patient reported outcome of CGM incorporation into patient diabetes care burden.

IV. Evaluate effect of CGM on depression score before and after CGM use.

OUTLINE:

Prior to hospital discharge, patients receive CGM application and education on how to apply the CGM, and how to use the sensor and its associated smart phone application (app). Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days.

Conditions

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Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (CGM)

Prior to hospital discharge, patients receive CGM application and education on how to apply the CGM, and how to use the sensor and its associated smart phone app. Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive basic diabetes mellitus education

Medical Device Usage and Evaluation

Intervention Type OTHER

Use CGM device and app

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Receive basic diabetes mellitus education

Intervention Type OTHER

Medical Device Usage and Evaluation

Use CGM device and app

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Insulin use \> 10 units per day
* Hemoglobin A1c \> 8.5%
* Smart phone compatible with LibreView App

Exclusion Criteria

* Type 1 diabetes mellitus (DM)
* Inability to consent
* Pregnancy
* Prisoners
* Discharge to skilled nursing facility
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Dungan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen M Dungan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2021-06008

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-21093

Identifier Type: -

Identifier Source: org_study_id

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