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NCT Number: NCT04370171

Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic

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.

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Key information

Conditions

Diabetes COVID-19 Coronaviridae Infections Coronavirus Infections Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

care modalities

Other

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 consultation

Other

Management of diabetic patients by telemedicine with a teleconsultation either by phone or by computer consultation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. Number of complications: severe hypoglycemia, ketoacidosis, myocardial infarction, stroke, foot ulcer.

    Time frame: Number of complications through study completion, an average of 6 months.

  4. 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.

    This questionnaire is not a score on a scale, there is no minimum or maximum values.

  5. Results of doctor satisfaction questionnaire.

    Time frame: Physician will respond to the questionnaires at study completion, 6 months after the inclusion visit.

    This questionnaire is not a score on a scale, there is no minimum or maximum values.

  6. 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).

  7. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic: Prospective Observational Study

Acronym: TeleCoviDiab

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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