Tele-expertise in Patients With Diabetes Hospitalized for Covid-19 Infection (COVIDEX)

Tele-expertise for Glycemic Control Monitoring in Patients With Diabetes Hospitalized for Covid-19 Infection

Diabetes is a major factor of morbi-mortality in Covid-19 infection. Currently, steroid therapy is required in patients under oxygen therapy. This treatment is associated with hyper glycaemia in patients with diabetes. Recommendations for the management of diabetes during Covid-19 infection is to use insulin treatment. The majority of units involves in the management of patient with Covid19 infection are not the experience in managing intensive insulin therapy and the time to ensure this follow-up. All the data in the literature are in favor of a positive impact of telemedicine on the metabolic control of diabetic patients. However, the routine use of telemedicine and more particularly tele-expertise within hospital units is very underdeveloped in France. The epidemic of Covid-19 represents a unique situation where the health authorities recommend to physicians to use telemedicine to ensure the follow-up and optimal management of patients. The aim of this study was to compare the metabolic control of diabetic patients infected with Covid-19 followed in tele-expertise to a group of diabetic patients infected with Covid-19 managed in standard conditions.

Study Overview

• Status: Terminated
• Conditions: Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment
• Intervention / Treatment: Device: Continuous blind glucose measurement device (Free style Pro)

Detailed Description

The study will take place in the infectious diseases department of the University Hospitals of Strasbourg. All diabetic patients or patients with corticosteroid-induced diabetes hospitalized for Covid-19 infection and requiring corticosteroid therapy (Dexamethasone 6mg / day IV for 10 days or Solupred 40mg / day per os) can be recruited.

Subjects meeting the eligibility criteria will be informed of the research orally and by the delivery of a written information notice from the start of their hospitalization in the department:

The allocation of the study group will be made according to the patient's hospitalization unit in the infectious disease department, unit 1 will benefit from tele-expertise (TE group) and patients in unit 2 will belong to the standard group (group S). Unit 1 and Unit 2 of the infectious disease department take care of patients in the same way..

The TE group consists of patients treated from the start of steroid therapy with a basal / bolus insulin regimen at a dose of 0.5U / kg / day: 50% in basal insulin Abasaglar and 50% in rapid insulin Humalog divided into three prandial injections with adaptation of insulin doses on the basis of the MCG. The use of the MCG with a collection of 90 glycemia / day allows the establishment of an intensive insulin treatment in complete safety because of the access to postprandial glycemia for the adaptation of rapid insulin and glycemia nocturnal for adaptation of basal insulin. The implementation of a basal bolus insulin therapy in a non-diabetes unit is made possible by continuous glucose measurement. Freestyle libre will therefore be implemented as soon as the insulin treatment is carried out. The Freestyle libre continuous glucose measurement sensor provides access to 90 interstitial glucose measurements / day and the establishment of continuous glucose measurement curves sent by secure computer every 48 hours for diabetes advice and dose adjustment insulin It is suggested for the study to carry out at least 8 glucose measurements / day per Free style Libre scanner. Therefore, there will be no achievement of capillary blood glucose in the TE group

The standard group (S) consists of patients for whom diabetes management is carried out according to the habits of the infectious disease department. This standard care includes the initiation of insulin therapy (one to several injections of insulin per day) in a context of hyperglycemia according to the habits of the department. The adjustment of the insulin doses in the S group will be carried out on the basis of at least 3 capillary blood glucose tests per day carried out before each meal. Group S will benefit from the fitting of a Freestyle Libre Pro, that is to say a continuous glucose sensor fitted throughout the hospital stay. The Freestyle Libre Pro, does not provide access to real-time interstitial glucose readings but has the option once removed to be able to analyze all 90 interstitial glucose readings. Its interest is to avoid interfering with the standard diabetes management of the infectious disease department.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient adult hospitalized for Covid-19 infection in the Infectious Diseases Department of the University Hospital of Strasbourg (HUS)
• Patient requiring steroid treatment
• Diabetic patient (type 1,2, MODY, secondary) or with corticosteroid-induced diabetes following initiation of corticosteroid treatment

Exclusion Criteria:

• Contraindication to the use of the Free-Style Medical Device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Tele-expertise; Basal-bolus insulin treatment with adaptation of insulin doses according to continuous glucose measurement
Experimental: Standard; Standard treatment and adaptation of insulin doses according to the usual management of the unit	Device: Continuous blind glucose measurement device (Free style Pro); A continuous blind glucose measurement device (Free style Pro) will be set up on the first day and throughout the entire hospital stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the range 70-180 mg / dl (TIR)	measured every day in the group followed by tele-expertise compared with group under standard care (comparison of the daily evolution of the TIR in both groups).	At the end of hospitalization (maximum day 14)

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	At the end of hospitalization (maximum day 14)
Intensive Care Unit Transfers	At the end of hospitalization (maximum day 14)
Cardiovascular and infectious complications	At the end of hospitalization (maximum day 14)
Acute metabolic complications: keto acidosis, severe hypoglycaemia	At the end of hospitalization (maximum day 14)
Duration of hospitalization and treatments administered	At the end of hospitalization (maximum day 14)
Mean glucose	At the end of hospitalization (maximum day 14)
Time spent above glycaemia > 180mg/dl	At the end of hospitalization (maximum day 14)
Time spent bellow glycaemia < 70mg/dl	At the end of hospitalization (maximum day 14)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Covid-19; Continuous glucose monitoring; Telemedecine; Steroid therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus
• Other Study ID Numbers: 8078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No