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Device

Cloud-Based Continuous Glucose Monitoring for Type 2 Diabetes

N/A

Waitlist Available

Led By Athena Philis-Tsimikas, MD

Research Sponsored by Scripps Whittier Diabetes Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days from the discharge date of the index hospitalization

Awards & highlights

Study Summary

This trial is testing an innovative new system that uses a wireless device to monitor a patient's glucose levels and sends the data to a digital dashboard. The goal is to reduce the risk of complications from uncontrolled blood sugar for people with diabetes who are in the hospital.

Eligible Conditions

Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days from the discharge date of the index hospitalization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days from the discharge date of the index hospitalization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days from the discharge date of the index hospitalization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage time in hypoglycemia of interstitial glucose values

Percentage time in severe hyperglycemia of interstitial glucose values

Percentage time-in-range of interstitial glucose values

Secondary outcome measures

Cost of hospitalization

Hospital readmission rate

Infection rates

+1 more

Other outcome measures

CGM Satisfaction

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention CB CGMExperimental Treatment1 Intervention

On CB CGM patients, CGM data will also be transmitted from the bedside smartphone to the Digital Dashboard. The Digital Dashboard will integrate CGM data for CB CGM's participants for presentation via two views: (1) Real-Time Management and (2) Clinical Optimization. Telemetry technicians to conduct site-based monitoring, and the Diabetes APN will conduct remote management of patients at the site from a central, Scripps Diabetes Hub, per below. (Note, as CGMs are not FDA-approved for in-hospital glucose management, CB CGM participants will also have their glucose monitored via the hospital's standard POC testing protocol described for UC).

Group II: Usual CareActive Control1 Intervention

For UC, CGM data will be blinded to the care team and used for evaluation purposes only. Glucose will be monitored via the hospital's standard POC testing protocol (i.e., prior to meals and at bedtime for patients who are eating, and every 4-6 waking hours for patients who are not eating). Glucose management in UC is designed to minimize differences between groups, aside from CGM monitoring: UC (and intervention) participants' glucose levels will be managed using the glucose management protocol and the Diabetes APN will assess UC participants' POC data documented in the EMR from the previous 24-48 hours and make recommendations for changes to the basal/bolus regimen to improve glucose management.

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Who is running the clinical trial?

Scripps Whittier Diabetes InstituteLead Sponsor

17 Previous Clinical Trials

5,383 Total Patients Enrolled

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,844 Total Patients Enrolled

Athena Philis-Tsimikas, MDPrincipal Investigator - Scripps Whittier Diabetes Institute

Scripps Whittier Diabetes Institute

13 Previous Clinical Trials

4,653 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to take part in this scientific experiment?

"This clinical investigation seeks to recruit 300 participants aged 18-100 with type two diabetes. Eligible patients must be able to communicate in either English or Spanish, possess a documented medical record indicating their diagnosis of T2DM, have evidence of taking antihyperglycemic agents as per the EMR, or present an initial serum/POC glucose reading above 200mg/dL within 24 hours of admission."

Answered by AI

Could potential participants register for this research at present?

"This medical trial, which was initially unveiled on February 25th 2020 is still actively recruiting participants. The study's details were last revised on May 10th 2022 according to clinicaltrials.gov."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Indeed, according to clinicaltrials.gov this medical trial is still recruiting patients. It was initially announced on February 25th 2020 and the last update took place on May 10th 2022. This research endeavour requires 300 participants from a single site."

Answered by AI

Is the target demographic of this research encompassing individuals aged 35 or over?

"The patient pool for this clinical trial comprises individuals between the age of 18 and 100."

Answered by AI

What is the desired outcome of this exploration?

"The DexCom Inc. sponsored study seeks to evaluate the Percentage time in severe hyperglycemia of interstitial glucose values over a three day period as its main objective. Additionally, researchers are looking into Cost of hospitalization, Infection rates, and Hospital readmission rate as secondary outcomes for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Scripps Digital Diabetes: Cloud-Based Continuous Glucose Monitoring (CB CGM)

Athena Philis-Tsimikas 2020. "Scripps Digital Diabetes: Cloud-Based Continuous Glucose Monitoring (CB CGM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04269655.