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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04277780
• Other study ID #: 5100
• Status: Terminated
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	The difference of the average changes in HbA1c from baseline between each group (intervention vs control)	Measured at the 180-day interval post-intervention
Primary	# of E.D. visits	Number of ED visits after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data	Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Primary	# od hospital re-admissions	Number of hospital re-admissions after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data	Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Secondary	Time till first E.D. Visit	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	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
Secondary	Diabetes Mellitus (DM) Management change based on CGM sensor/log data	% of patients whose diabetes management was changed based on CGM sensor data or blood glucose log	assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Secondary	Time till first hypoglycemic event	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	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
Secondary	HbA1c <9.0% at the end of study	# of patients with a HbA1c <9.0% at the end of the study compared to baseline	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
Secondary	Outpatient Visit Compliance	% of patients who kept their outpatient clinic visits for diabetes (compliance)	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
Secondary	Severity of first hypoglycemic event	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	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