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

NCT04277780 | Terminated FDA Device

• 1 other identifier: 5100
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

continuous glucose monitoring sensors; hospital readmission

Outcome Measures

Primary Outcomes (3)

• 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

• # 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

• # 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 Outcomes (6)

• Time till first E.D. Visit

  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

• Diabetes Mellitus (DM) Management change based on CGM sensor/log data

  assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data

• Time till first hypoglycemic event

  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

• HbA1c <9.0% at the end of study

  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

• Outpatient Visit 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

Study Arms (2)

CGM Sensor

EXPERIMENTAL

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; Other: Diabetes Management Instructions

Conventional Diabetes Care

ACTIVE COMPARATOR

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

Interventions

Continuous Glucose Monitoring Sensor DEVICE

Placement of continuous glucose monitor sensor for 14 days. Instructions on how to peel off the sensor and mail it back to the clinician.

CGM Sensor

Diabetes Management Instructions OTHER

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.

CGM Sensor; Conventional Diabetes Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Catherine Anastasopoulou, MD, PhD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrine Chair, Einstein Healthcare Network

Model Details: 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)

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: February 20, 2020
• Study Start: October 31, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)