DiabetesTeleCoviDiabNCT04370171
Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic
An observational study of Diabetes and Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- care modalities and Teleconsultation either by phone or by computer consultation
- How many people
- 610 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2020to 29 May 2020
- Phase
- Observational
- 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
Study population: Diabetic patients regularly followed in a clinic at the University Hospital of Strasbourg or followed by a liberal diabetologist in Strasbourg
Who may be able to join
- Adult diabetic patient (type 1,2, MODY, secondary, post transplantation) followed by diabetology consultation at the hospital or by a liberal diabetologist
- Subject affiliated to a social health insurance
- Subject able to understand the objectives of the research
- Subject who expressed his non opposition to the research
Who cannot join
- Pregnant woman
- Patients with acute complications (foot ulcer, post stroke, post IDM)
- Cancer or life expectancy of less than 6 months
- Inability to provide informed information to the subject (subject in an emergency, difficulty of understanding for the subject, etc.)
- Subject under judicial protection
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic: Prospective Observational Study
Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Among the hospitalized patients reported in the initial Chinese studies, 48% had co-morbidity, particularly diabetes or cardiovascular disease. Covid-19 infection does not appear to be more common in diabetic patients, but infected diabetics have more severe forms.
The prevalence of diabetes is high in Alsace affecting 6.5% of the population against 4.6% in France. Du to health containment measures, asymptomatic diabetic patients can no longer come to the clinic in Hospital for their consultation. However, in the current epidemiological context, maintaining optimal glycemic control is fundamental since some of diabetic patients will have Covid-19 infections. Furthermore, the sedentary lifestyle and snacking linked to the confinement period will contribute to a glycemic imbalance in some patients. Telemedicine, and in particular teleconsultation, which until now has been very uncommon in the management of diabetic patients, represents a very interesting alternative for monitoring these patients and maintaining satisfactory metabolic control during the current period of confinement and Covid-19 epidemic.
- Being tested
- care modalities, Teleconsultation either by phone or by computer consultation
- Keywords
- Diabetes, Telemedicine, Covid-19 epidemic, Glucose control
- Medical subject headings
- Diabetes Mellitus, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care modalitiesOther
For these patients the consultation has been postponed for 6 months. No specific intervention for this group of patient.
Teleconsultation either by phone or by computer consultationOther
Management of diabetic patients by telemedicine with a teleconsultation either by phone or by computer consultation
| Study group | Role | What they receive |
|---|---|---|
| Group TC: Diabetic patients followed by Teleconsultation | Teleconsultation group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist has been replaced by a teleconsultation due to the availability of diabetologists whose activity is focused on the management of Covid-19 negative patients. Receives: Other: Teleconsultation either by phone or by computer consultation | |
| Group P: Diabetic patients with conventional follow-up | Conventional group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist was differed by 6 months due to the activity of some diabetologists entirely redirected towards the management of Covid-19 positive patients and not available Receives: Other: care modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of metabolic control (HbA1C) between diabetic patients followed by teleconsultation and patients with a conventional follow-up during Covid-19 infection.
In the Covid 19 epidemic context, the face-to-face consultation of diabetic patients with the hospital's physician or their diabetologist is / will be replaced by a teleconsultation ( phone or computer consultation) followed at 6 months of a face-to-face consultation. Patients will be monitored in accordance with routine practice.
The Teleconsultation (TC) group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist has been replaced by a teleconsultation due to the availability of diabetologists whose activity is focused on the management of Covid-19 negative patients.
The Face-to-Face group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist was postponed by 6 months due to the activity of some diabetologists entirely redirected towards the management of Covid-19 positive patients.
Measured: HbA1C measured at 3 months post-telemedicine consultation group / post-cancellation of the face-to-face consultation group (variation versus basal)
Secondary outcomes (7)
HbA1C measured at 6 months post-telemedicine consultation for the TC group / post-cancellation of the face-to-face consultation for the P group.
Measured: HbA1C will be measured at visit V2 (6 months after inclusion visit)=through study completion, an average of 6 months
Total number of patients inaccessible to teleconsultation and number of patients inaccessible by type of associated reason.
Measured: Total number of patients inaccessible to teleconsultation will be collected through study completion, an average of 6 months.
Number of complications: severe hypoglycemia, ketoacidosis, myocardial infarction, stroke, foot ulcer.
Measured: Number of complications through study completion, an average of 6 months.
Results of patient satisfaction questionnaire.
This questionnaire is not a score on a scale, there is no minimum or maximum values.
Measured: Patients will respond to the questionnaires either at the end of study (6 months after inclusion) or in the month following the teleconsultation.
Results of doctor satisfaction questionnaire.
This questionnaire is not a score on a scale, there is no minimum or maximum values.
Measured: Physician will respond to the questionnaires at study completion, 6 months after the inclusion visit.
Number of patients infected with Covid-19 (positive smear by RT-PCR for SARS-CoV-2 virus).
Measured: Number of patients infected with Covid-19 during the study (6 months).
Number of conventional hospitalizations, in intensive care and deaths.
Measured: Number of conventional hospitalizations, in intensive care and deaths during the study (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start4 May 2020
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 610 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
- NCT04370171
- Sponsor's protocol ID
- 7775
- Acronym
- TeleCoviDiab
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04370171
- Acronym / sponsor ID
- TeleCoviDiab / 7775
- Keywords
- Diabetes, Telemedicine, Covid-19 epidemic, Glucose control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 30 Apr 2020 (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.
Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Among the hospitalized patients reported in the initial Chinese studies, 48% had co-morbidity, particularly diabetes or cardiovascular disease. Covid-19 infection does not appear to be more common in diabetic patients, but infected diabetics have more severe forms.
The prevalence of diabetes is high in Alsace affecting 6.5% of the population against 4.6% in France. Du to health containment measures, asymptomatic diabetic patients can no longer come to the clinic in Hospital for their consultation. However, in the current epidemiological context, maintaining optimal glycemic control is fundamental since some of diabetic patients will have Covid-19 infections. Furthermore, the sedentary lifestyle and snacking linked to the confinement period will contribute to a glycemic imbalance in some patients. Telemedicine, and in particular teleconsultation, which until now has been very uncommon in the management of diabetic patients, represents a very interesting alternative for monitoring these patients and maintaining satisfactory metabolic control during the current period of confinement and Covid-19 epidemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TC: Diabetic patients followed by Teleconsultation | – | Other: Teleconsultation either by phone or by computer consultationTeleconsultation group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist has been replaced by a teleconsultation due to the availability of diabetologists whose activity is focused on the management of Covid-19 negative patients. |
| Group P: Diabetic patients with conventional follow-up | – | Other: care modalitiesConventional group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist was differed by 6 months due to the activity of some diabetologists entirely redirected towards the management of Covid-19 positive patients and not available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients regularly followed in a clinic at the University Hospital of Strasbourg or followed by a liberal diabetologist in Strasbourg
Key inclusion criteria (4 listed)
- Adult diabetic patient (type 1,2, MODY, secondary, post transplantation) followed by diabetology consultation at the hospital or by a liberal diabetologist
- Subject affiliated to a social health insurance
- Subject able to understand the objectives of the research
- Subject who expressed his non opposition to the research
Key exclusion criteria (6 listed)
- Pregnant woman
- Patients with acute complications (foot ulcer, post stroke, post IDM)
- Cancer or life expectancy of less than 6 months
- Inability to provide informed information to the subject (subject in an emergency, difficulty of understanding for the subject, etc.)
- Subject under judicial protection
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 |
|---|---|---|
| care modalitiesFor these patients the consultation has been postponed for 6 months. No specific intervention for this group of patient. | Other | Group P: Diabetic patients with conventional follow-up |
| Teleconsultation either by phone or by computer consultationManagement of diabetic patients by telemedicine with a teleconsultation either by phone or by computer consultation | Other | Group TC: Diabetic patients followed by Teleconsultation |
Primary outcome
Comparison of metabolic control (HbA1C) between diabetic patients followed by teleconsultation and patients with a conventional follow-up during Covid-19 infection.
Time frame: HbA1C measured at 3 months post-telemedicine consultation group / post-cancellation of the face-to-face consultation group (variation versus basal)
In the Covid 19 epidemic context, the face-to-face consultation of diabetic patients with the hospital's physician or their diabetologist is / will be replaced by a teleconsultation ( phone or computer consultation) followed at 6 months of a face-to-face consultation. Patients will be monitored in accordance with routine practice. The Teleconsultation (TC) group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist has been replaced by a teleconsultation due to the availability of diabetologists whose activity is focused on the management of Covid-19 negative patients. The Face-to-Face group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist was postponed by 6 months due to the activity of some diabetologists entirely redirected towards the management of Covid-19 positive patients.
7 secondary outcomes
HbA1C measured at 6 months post-telemedicine consultation for the TC group / post-cancellation of the face-to-face consultation for the P group.
Time frame: HbA1C will be measured at visit V2 (6 months after inclusion visit)=through study completion, an average of 6 months
Total number of patients inaccessible to teleconsultation and number of patients inaccessible by type of associated reason.
Time frame: Total number of patients inaccessible to teleconsultation will be collected through study completion, an average of 6 months.
Number of complications: severe hypoglycemia, ketoacidosis, myocardial infarction, stroke, foot ulcer.
Time frame: Number of complications through study completion, an average of 6 months.
Results of patient satisfaction questionnaire.
Time frame: Patients will respond to the questionnaires either at the end of study (6 months after inclusion) or in the month following the teleconsultation.
Results of doctor satisfaction questionnaire.
Time frame: Physician will respond to the questionnaires at study completion, 6 months after the inclusion visit.
Number of patients infected with Covid-19 (positive smear by RT-PCR for SARS-CoV-2 virus).
Time frame: Number of patients infected with Covid-19 during the study (6 months).
Number of conventional hospitalizations, in intensive care and deaths.
Time frame: Number of conventional hospitalizations, in intensive care and deaths during the study (6 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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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?
An observational study of Diabetes and Covid-19, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Nov 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of metabolic control (HbA1C) between diabetic patients followed by teleconsultation and patients with a conventional follow-up during Covid-19 infection. (time frame: HbA1C measured at 3 months post-telemedicine consultation group / post-cancellation of the face-to-face consultation group (variation versus basal)). 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 10 Nov 2020.