NCT04277780

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

Terminated NA Last updated 6 April 2021

What this trial tests

NA trial testing Continuous Glucose Monitoring Sensor in Type 2 Diabetes Mellitus in 58 participants. Terminated before completion.

Timeline

31 October 2018

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Albert Einstein Healthcare Network
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	58
Start date	31 October 2018
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Continuous Glucose Monitoring Sensor
• Diabetes Management Instructions

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Albert Einstein Healthcare Network

Who can join

18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline.
   Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, et al · · 2020 · cited 118× · PMID 32985262 · DOI 10.1177/1932296820954163