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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

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ClinicalTrials.gov Identifier: NCT04938869
Recruitment Status : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date June 24, 2021
Estimated Study Start Date  ICMJE July 1, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • Change in DTSQ scores [ Time Frame: 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.
  • Overall control [ Time Frame: Up to 4 weeks post-discharge ]
    Descriptive statistics will summarize the sample characteristics and distribution of each variable.
  • Change in various measures of control [ Time Frame: 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.
  • Number of patients with successful data collection [ Time Frame: At 2 weeks ]
    Descriptive statistics will summarize the sample characteristics and distribution of each variable.
  • Number of patients with successful data collection [ Time Frame: At 4 weeks ]
    Descriptive statistics will summarize the sample characteristics and distribution of each variable.
  • Change in Patient Health Questionnaire scores [ Time Frame: 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.
  • Incidence of adverse events [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer
Official Title  ICMJE Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Hematopoietic and Lymphoid System Neoplasm
  • Malignant Solid Neoplasm
  • Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Other: Educational Intervention
  • Other: Medical Device Usage and Evaluation
  • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938869
Other Study ID Numbers  ICMJE OSU-21093
NCI-2021-06008 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathleen Dungan, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen M Dungan, MD, MPH Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP