NCT04277780

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

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-31
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-02-20
• Last updated: 2021-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study