Clinical trial NCT04370171: Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic
Official title: Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Covid-19
Keywords: Diabetes
Telemedicine
Covid-19 epidemic
Glucose control
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients regularly followed in a clinic at the University Hospital of Strasbourg or followed by a liberal diabetologist in Strasbourg

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of metabolic control (HbA1C) between diabetic patients followed by teleconsultation and patients with a conventional follow-up during Covid-19 infection.
timeFrame: HbA1C measured at 3 months post-telemedicine consultation group / post-cancellation of the face-to-face consultation group (variation versus basal)
Secondary outcomes:
measure: HbA1C measured at 6 months post-telemedicine consultation for the TC group / post-cancellation of the face-to-face consultation for the P group.
timeFrame: HbA1C will be measured at visit V2 (6 months after inclusion visit)=through study completion, an average of 6 months
measure: Total number of patients inaccessible to teleconsultation and number of patients inaccessible by type of associated reason.
timeFrame: Total number of patients inaccessible to teleconsultation will be collected through study completion, an average of 6 months.
measure: Number of complications: severe hypoglycemia, ketoacidosis, myocardial infarction, stroke, foot ulcer.
timeFrame: Number of complications through study completion, an average of 6 months.
measure: Results of patient satisfaction questionnaire.
timeFrame: Patients will respond to the questionnaires either at the end of study (6 months after inclusion) or in the month following the teleconsultation.
measure: Results of doctor satisfaction questionnaire.
timeFrame: Physician will respond to the questionnaires at study completion, 6 months after the inclusion visit.
measure: Number of patients infected with Covid-19 (positive smear by RT-PCR for SARS-CoV-2 virus).
timeFrame: Number of patients infected with Covid-19 during the study (6 months).
measure: Number of conventional hospitalizations, in intensive care and deaths.
timeFrame: Number of conventional hospitalizations, in intensive care and deaths during the study (6 months).
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: