Tele-expertise in Patients With Diabetes Hospitalized for Covid-19 Infection (COVIDEX)
Primary Purpose
Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous blind glucose measurement device (Free style Pro)
Sponsored by
About this trial
This is an interventional other trial for Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment focused on measuring Diabetes, Covid-19, Telemedecine, Continuous glucose monitoring, Steroid therapy
Eligibility Criteria
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
Sites / Locations
- Hopitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Tele-expertise
Standard
Arm Description
Basal-bolus insulin treatment with adaptation of insulin doses according to continuous glucose measurement
Standard treatment and adaptation of insulin doses according to the usual management of the unit
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Mortality
Intensive Care Unit Transfers
Cardiovascular and infectious complications
Acute metabolic complications: keto acidosis, severe hypoglycaemia
Duration of hospitalization and treatments administered
Mean glucose
Time spent above glycaemia > 180mg/dl
Time spent bellow glycaemia < 70mg/dl
Full Information
NCT ID
NCT04726163
First Posted
January 19, 2021
Last Updated
April 19, 2022
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04726163
Brief Title
Tele-expertise in Patients With Diabetes Hospitalized for Covid-19 Infection
Acronym
COVIDEX
Official Title
Tele-expertise for Glycemic Control Monitoring in Patients With Diabetes Hospitalized for Covid-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
inclusion difficulties
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment
Keywords
Diabetes, Covid-19, Telemedecine, Continuous glucose monitoring, Steroid therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-expertise
Arm Type
No Intervention
Arm Description
Basal-bolus insulin treatment with adaptation of insulin doses according to continuous glucose measurement
Arm Title
Standard
Arm Type
Experimental
Arm Description
Standard treatment and adaptation of insulin doses according to the usual management of the unit
Intervention Type
Device
Intervention Name(s)
Continuous blind glucose measurement device (Free style Pro)
Intervention Description
A continuous blind glucose measurement device (Free style Pro) will be set up on the first day and throughout the entire hospital stay
Primary Outcome Measure Information:
Title
Percentage of time spent in the range 70-180 mg / dl (TIR)
Description
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).
Time Frame
At the end of hospitalization (maximum day 14)
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
At the end of hospitalization (maximum day 14)
Title
Intensive Care Unit Transfers
Time Frame
At the end of hospitalization (maximum day 14)
Title
Cardiovascular and infectious complications
Time Frame
At the end of hospitalization (maximum day 14)
Title
Acute metabolic complications: keto acidosis, severe hypoglycaemia
Time Frame
At the end of hospitalization (maximum day 14)
Title
Duration of hospitalization and treatments administered
Time Frame
At the end of hospitalization (maximum day 14)
Title
Mean glucose
Time Frame
At the end of hospitalization (maximum day 14)
Title
Time spent above glycaemia > 180mg/dl
Time Frame
At the end of hospitalization (maximum day 14)
Title
Time spent bellow glycaemia < 70mg/dl
Time Frame
At the end of hospitalization (maximum day 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hopitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tele-expertise in Patients With Diabetes Hospitalized for Covid-19 Infection
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