Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid TreatmentCOVIDEXNCT04726163
Tele-expertise in Patients With Diabetes Hospitalized for Covid-19 Infection
A study testing Continuous blind glucose measurement device (Free style Pro) in people with Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment
- What is being tested?
- Continuous blind glucose measurement device (Free style Pro)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2021to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to the use of the Free-Style Medical Device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Continuous blind glucose measurement device (Free style Pro)
- Keywords
- Diabetes, Covid-19, Telemedecine, Continuous glucose monitoring, Steroid therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Neoplasm Metastasis, Diabetes Mellitus, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous blind glucose measurement device (Free style Pro)Device
A continuous blind glucose measurement device (Free style Pro) will be set up on the first day and throughout the entire hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Tele-expertise | No intervention | Basal-bolus insulin treatment with adaptation of insulin doses according to continuous glucose measurement |
| Standard | Experimental | Standard treatment and adaptation of insulin doses according to the usual management of the unit Receives: Device: Continuous blind glucose measurement device (Free style Pro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the end of hospitalization (maximum day 14)
Secondary outcomes (8)
Mortality
Measured: At the end of hospitalization (maximum day 14)
Intensive Care Unit Transfers
Measured: At the end of hospitalization (maximum day 14)
Cardiovascular and infectious complications
Measured: At the end of hospitalization (maximum day 14)
Acute metabolic complications: keto acidosis, severe hypoglycaemia
Measured: At the end of hospitalization (maximum day 14)
Duration of hospitalization and treatments administered
Measured: At the end of hospitalization (maximum day 14)
Mean glucose
Measured: At the end of hospitalization (maximum day 14)
Time spent above glycaemia > 180mg/dl
Measured: At the end of hospitalization (maximum day 14)
Time spent bellow glycaemia < 70mg/dl
Measured: At the end of hospitalization (maximum day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start29 Jan 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Why it stopped: inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726163
- Sponsor's protocol ID
- 8078
- Acronym
- COVIDEX
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-expertise for Glycemic Control Monitoring in Patients With Diabetes Hospitalized for Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04726163
- Acronym / sponsor ID
- COVIDEX / 8078
- Keywords
- Diabetes, Covid-19, Telemedecine, Continuous glucose monitoring, Steroid therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulties
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-expertise | No intervention | –Basal-bolus insulin treatment with adaptation of insulin doses according to continuous glucose measurement |
| Standard | Experimental | Device: Continuous blind glucose measurement device (Free style Pro)Standard treatment and adaptation of insulin doses according to the usual management of the unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication to the use of the Free-Style Medical Device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Standard |
Primary outcome
Percentage of time spent in the range 70-180 mg / dl (TIR)
Time frame: At the end of hospitalization (maximum day 14)
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).
8 secondary outcomes
Mortality
Time frame: At the end of hospitalization (maximum day 14)
Intensive Care Unit Transfers
Time frame: At the end of hospitalization (maximum day 14)
Cardiovascular and infectious complications
Time frame: At the end of hospitalization (maximum day 14)
Acute metabolic complications: keto acidosis, severe hypoglycaemia
Time frame: At the end of hospitalization (maximum day 14)
Duration of hospitalization and treatments administered
Time frame: At the end of hospitalization (maximum day 14)
Mean glucose
Time frame: At the end of hospitalization (maximum day 14)
Time spent above glycaemia > 180mg/dl
Time frame: At the end of hospitalization (maximum day 14)
Time spent bellow glycaemia < 70mg/dl
Time frame: At the end of hospitalization (maximum day 14)
Results and safety
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous blind glucose measurement device (Free style Pro) in people with Diabetic Patient (Type 1,2, MODY, Secondary) or With Corticosteroid-induced Diabetes Following Initiation of Corticosteroid Treatment, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent in the range 70-180 mg / dl (TIR) (time frame: At the end of hospitalization (maximum day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.