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Reducing Emergency Department Visits and Improving Glucose Control in Uncontrolled Type 2 Diabetes Using CGM Sensors at Hospital Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277780
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Catherine Anastasopoulou, MD, PhD, FACE, Albert Einstein Healthcare Network

Brief Summary:
Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on the system are a necessity. Use of FDA-approved continuous glucose monitoring (CGM) sensors have shown benefit in better management plans in the outpatient setting. Hence, this study hypothesizes that using CGM sensors starting in the inpatient setting will provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. The study will randomly assign patients to either receive a CGM sensor plus the standard diabetes management and instructions or who will only receive the standard diabetes management. The patients will be followed in the outpatient endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Continuous Glucose Monitoring Sensor Other: Diabetes Management Instructions Not Applicable

Detailed Description:

Rationale: Quality measures and cost-reduction methods are a high priority in the United States health care system currently. This includes the high burden of patients with uncontrolled Type 2 Diabetes on the system especially given the continued dramatic rise in the prevalence of these patients. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on our health care system are a necessity. The use of continuous glucose monitoring (CGM) sensors have already shown benefit in better management plans in the outpatient setting. Hence, this study aims to assess the use of CGM sensors starting in the inpatient setting and whether they will help provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates.

Objectives: To determine whether the use of CGM sensors in patients with uncontrolled type 2 diabetes at the time of hospital discharge leads to improved glucose control and a reduction of E.D visits and hospital readmission rates.

Trial Design: The trial design will be a randomized, non-blinded prospective study; a 1:1 comparison of uncontrolled type 2 diabetes patients who receive CGM sensors + conventional diabetes management at the time of discharge versus uncontrolled type 2 diabetes patients who receive only the conventional diabetes management.

Study Setting: Study setting will be at the Albert Einstein Medical Center (AEMC), Philadelphia, Pennsylvania for the inpatient type 2 diabetes population who will be followed at the AEMC endocrinology clinics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 70 patients assigned to intervention group (to receive CGM sensor + conventional diabetes management); 70 patients assigned to control group (to receive only conventional diabetes management)
Masking: Single (Outcomes Assessor)
Masking Description: Statistical analysis to be performed on the primary and secondary outcome measure data will be provided to the assessor without information indicating whether or not a subject received the CGM sensor.
Primary Purpose: Treatment
Official Title: Reducing E.D. Visits and Hospital Readmissions, and Improving Glucose Control of Patients With Uncontrolled Type 2 Diabetes by Use of Continuous Glucose Monitoring Sensors Placed at Hospital Discharge.
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: CGM Sensor
Subjects will receive the Libre Pro Freestyle continuous glucose monitor (CGM) sensor that will be applied to their upper arm at the time of hospital discharge. They will be asked to peel off the sensor after 14 days and mail it to the endocrinology clinic in a stamped envelope that will be provided. They will also be provided the conventional diabetes management which will include instructions on fingerstick blood glucose monitoring and logging which they will start after the CGM sensor is removed. The sensor data will be analyzed by a clinician who will call the subject regarding any changes to their diabetes management. The subject will then be asked to follow-up at the endocrinology clinic 1-month, 3-month, and 6-month from the time the sensor is placed for further management of their diabetes.
Device: Continuous Glucose Monitoring Sensor
Placement of continuous glucose monitor sensor for 14 days. Instructions on how to peel off the sensor and mail it back to the clinician.

Other: Diabetes Management Instructions
Instructions on checking fingerstick blood glucose and information on the required equipment including glucose test strips, lancets, and glucometer. Instructions on how to log blood glucose values onto the blood glucose log sheet for 14 days, and how to mail it back to the clinician.

Active Comparator: Conventional Diabetes Care
Subjects will receive only the conventional diabetes management at the time of hospital discharge which includes instruction on fingerstick blood glucose monitoring and logging onto a blood glucose log sheet for 14 days. They will then be asked to fax/mail/call-in the blood glucose log. The log data will be analyzed by a clinician who will call the subject regarding any changes to their diabetes management. The subject will then be asked to follow-up at the endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge for further management of their diabetes.
Other: Diabetes Management Instructions
Instructions on checking fingerstick blood glucose and information on the required equipment including glucose test strips, lancets, and glucometer. Instructions on how to log blood glucose values onto the blood glucose log sheet for 14 days, and how to mail it back to the clinician.




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Measured at the 180-day interval post-intervention ]
    The difference of the average changes in HbA1c from baseline between each group (intervention vs control)

  2. # of E.D. visits [ Time Frame: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    Number of ED visits after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data

  3. # od hospital re-admissions [ Time Frame: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    Number of hospital re-admissions after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data


Secondary Outcome Measures :
  1. Time till first E.D. Visit [ Time Frame: data collected for any visit occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    Length of time until first E.D. visit from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data

  2. Diabetes Mellitus (DM) Management change based on CGM sensor/log data [ Time Frame: assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    % of patients whose diabetes management was changed based on CGM sensor data or blood glucose log

  3. Time till first hypoglycemic event [ Time Frame: Data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    Time till first hypoglycemic from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data

  4. HbA1c <9.0% at the end of study [ Time Frame: Assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    # of patients with a HbA1c <9.0% at the end of the study compared to baseline

  5. Outpatient Visit Compliance [ Time Frame: assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    % of patients who kept their outpatient clinic visits for diabetes (compliance)

  6. Severity of first hypoglycemic event [ Time Frame: data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data ]
    Severity of first hypoglycemic event (based on self-management vs. need call to paramedics) from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • inpatient uncontrolled Type 2 Diabetes patients defined by HbA1c of ≥9.0% within the last 2-3 months
  • require an endocrinology consultation
  • will be followed at AEMC endocrinology clinic

Exclusion Criteria:

  • patients with HbA1c <9.0%
  • patients not managed by AEMC endocrinology clinic
  • Type 1 Diabetic patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277780


Contacts
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Contact: Catherine Anastasopoulou, MD, PhD 2155725200 anastasopoulouc@einstein.edu
Contact: Peter Ucciferro, DO 2155725200 ucciferp@einstein.edu

Locations
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United States, Pennsylvania
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Catherine Anastasopoulou, MD, PhD    215-572-5200    anastasopoulouc@einstein.edu   
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
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Principal Investigator: Catherine Anastasopoulou, MD, PhD Albert Einstein Healthcare Network

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Responsible Party: Catherine Anastasopoulou, MD, PhD, FACE, Endocrine Chair, Einstein Healthcare Network, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT04277780    
Other Study ID Numbers: 5100
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by Catherine Anastasopoulou, MD, PhD, FACE, Albert Einstein Healthcare Network:
continuous glucose monitoring sensors
hospital readmission
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases