Clinical trial NCT04277780: Reducing Emergency Department Visits and Improving Glucose Control in Uncontrolled Type 2 Diabetes Using CGM Sensors at Hospital Discharge
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: continuous glucose monitoring sensors
hospital readmission
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Measured at the 180-day interval post-intervention
measure: # of E.D. visits
timeFrame: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
measure: # od hospital re-admissions
timeFrame: 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 outcomes:
measure: Time till first E.D. Visit
timeFrame: 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
measure: Diabetes Mellitus (DM) Management change based on CGM sensor/log data
timeFrame: assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
measure: Time till first hypoglycemic event
timeFrame: 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
measure: HbA1c <9.0% at the end of study
timeFrame: 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
measure: Outpatient Visit Compliance
timeFrame: 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
measure: Severity of first hypoglycemic event
timeFrame: 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
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Catherine Anastasopoulou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: