NCT04871958: Initiator

Individualized, Technological Interventions for Diabetes Care in the COVID-19 Ward

Terminated NA Last updated 28 July 2022

What this trial tests

NA trial testing Continuous glucose monitoring (CGM, Dexcom G6) in Diabetes Mellitus in 66 participants. Terminated before completion.

Timeline

19 March 2021

Primary endpoint
31 August 2021

30 September 2021

Quick facts

Lead sponsor	Federico II University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	66
Start date	19 March 2021
Primary completion	31 August 2021
Estimated completion	30 September 2021
Sites	1 location across Italy

Drugs / interventions tested

• Continuous glucose monitoring (CGM, Dexcom G6)

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Covid19 — all drugs for Covid19 →

Sponsor

Federico II University

Who can join

18 and older, any sex, with Diabetes Mellitus or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

During the current Covid-19 pandemic, many hospitals worldwide have been overwhelmed and strategies based on new technologies have been considered to improve the outcomes in patients with diabetes and Covid-19 and to prevent healthcare workers' exposure. Point-of-care blood glucose measurements, with the need of frequent and intermittent blood glucose testing and the associated time burden for hospital staff workers, have evident limitations. To this respect, continuous glucose monitoring (CGM) might represent an effective tool in hospitalized patients. The latest CGM devices have alarms alerting clinicians (or patients) to abnormal blood glucose values. Furthermore, CGMs not requiring calibration with capillary glucose testing have the potential to decrease both nurse and patient burden.

Insulin therapy is recommended in hospitalized patients with diabetes and Covid-19, conventionally by multiple daily insulin injections, i.e., rapid-acting insulin before meals and long-acting insulin once-a-day. Such a complex regimen demands also multiple daily fingerstick for glucose control. Use of continuous subcutaneous insulin infusion in hospital has been considered, and simple, less sophisticated pumps might be appro¬priate for prompt use by healthcare providers not specialized in diabetes treatment. V-Go® is a skin-patch insulin delivery device to be replaced every 24 h. It is fully mechanical, without tubing or electronics, and does not require any programming. It delivers a continuous basal infusion of rapid-acting insulin and allows for additional units before meals.

Therefore, the implementation of CGM and automated insulin infusion in Covid-19 hospitals has the potential to improve clinical outcomes, protect frontline healthcare workers, and preserve personal protective equipment. However, because only observational retrospective data for CGM use and no data on insulin pump use are currently available, randomized controlled trials are needed to determine whether using these technologies in hospital is of significant help.

The aims of this study are to explore, in patients with diabetes in COVID-19 wards, whether using continuous glucose monitoring with a glucose telemetry system and/or using a disposable insulin pump may improve blood glucose control and Covid-19 outcomes, and facilitate diabetes management.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.