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

NCT04871958 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-07-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Continuous glucose monitoring (CGM, Dexcom G6)

The Dexcom G6 sensor will be placed on the back of the upper arm at admission and changed after 10 days. In the participants randomized to Real-time CGM, glucose values will be transmitted through Bluetooth to a mobile phone at the bedside. From this phone data are transmitted to a tablet in the nursing station. In the blinded CGM group, sensor readings will be blinded to patient and healthcare providers. The MDI groups will be managed with basal/bolus insulin regimen, as clinically indicated. V-Go will be placed on the abdomen each morning. Insulin-naïve patients randomized to the V-Go system will start at the lowest basal rate (20 UI/24h). On daily basis, expert diabetologists will retrospectively review CGM data and provide indications for insulin therapy adjustments.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-19
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871958 on ClinicalTrials.gov