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

NCT04871958 | Terminated

• 1 other identifier: Initiator
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus; Covid19

Keywords

Diabetes mellitus; Covid-19; Hospital care; Continuous glucose monitoring; Insulin pump; CGM metrics

Outcome Measures

Primary Outcomes (1)

• Blood glucose Time-In-Range (TIR) during hospital stay

  Percentage of time spent within the interval of blood glucose between 70 and 180 mg/dl

  From date of randomization until the date of discharge from the hospital ward up to 2 months

Secondary Outcomes (5)

• Hypoglycemia events

  From date of randomization until the date of discharge from the hospital ward up to 2 months

• Change in fructosamine

  Date of admission and day of discharge from the hospital ward

• Change in COVID-19 severity score

  Date of admission and day of discharge from the hospital ward

• Length of stay in the hospital ward

  From date of randomization until the date of discharge from the hospital ward up to 2 months

• Accesses to the isolation room

  From date of randomization until the date of discharge from the hospital ward up to 2 months

Study Arms (3)

rtCGM/MDI

EXPERIMENTAL

Real-time CGM, insulin therapy by multiple daily injections managed according to CGM

Device: Continuous glucose monitoring (CGM, Dexcom G6)

rtCGM/V-Go

EXPERIMENTAL

Real-time CGM, insulin therapy by V-Go insulin pump managed according to CGM

Device: Continuous glucose monitoring (CGM, Dexcom G6)

blindCGM/MDI

NO INTERVENTION

Blind CGM, insulin therapy by multiple daily injections managed according to standard care (capillary glucose measurements)

Interventions

Continuous glucose monitoring (CGM, Dexcom G6) DEVICE

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.

Also known as: Continuous subcutaneous insulin infusion (V-Go)

rtCGM/MDI; rtCGM/V-Go

Eligibility Criteria

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

You may qualify if:

• All patients admitted at the COVID-19 non-ICU with a diagnosis of Type 2 or Secondary diabetes mellitus (DM) for whom intensive insulin therapy (basal plus at least two boluses) is indicated are eligible for the study.

You may not qualify if:

• Patients on hydroxyurea treatment are excluded (interference with glucose sensor readings).

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: All patients admitted at the COVID-19 non-ICU with a diagnosis of Type 2 or Secondary diabetes mellitus (DM) for whom intensive insulin therapy (basal plus at least two boluses) is indicated are eligible for the primary study. After stratification for admission ward, type of DM (known/unknown type 2, steroid use), age, and gender, participants will be randomized to one of the following interventions: 1. Real-time CGM, multiple daily injections managed according to CGM 2. Real-time CGM, insulin pump (V-Go) managed according to CGM 3. Blind CGM, multiple daily injections managed according to POC glucose testing.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: March 19, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

IT (1)