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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04938869
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
42
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Medical Device Usage and Evaluation
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Educational Intervention
Receive basic diabetes mellitus education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Medical Device Usage and Evaluation
    Use CGM device and app

    Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score [From baseline to 4 weeks post-discharge]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.

    Secondary Outcome Measures

    1. Change in DTSQ scores [From baseline to 2 weeks post-discharge]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.

    2. Overall control [Up to 4 weeks post-discharge]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable.

    3. Change in various measures of control [From week 1 to week 4]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.

    4. Number of patients with successful data collection [At 2 weeks]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable.

    5. Number of patients with successful data collection [At 4 weeks]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable.

    6. Change in Patient Health Questionnaire scores [From baseline to 4 weeks post-discharge]

      Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.

    7. Incidence of adverse events [Immediately following inpatient hospitalization]

      Will report the safety of continuous glucose monitor application and use. Descriptive statistics will summarize the sample characteristics and distribution of each variable.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Kathleen M Dungan, MD, MPH, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kathleen Dungan, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04938869
    Other Study ID Numbers:
    • OSU-21093
    • NCI-2021-06008
    First Posted:
    Jun 24, 2021
    Last Update Posted:
    Jun 24, 2021
    Last Verified:
    Jun 1, 2021
    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:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jun 24, 2021