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

NCT04370171 | Completed

• 1 other identifier: 7775
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Covid-19

Keywords

Diabetes; Telemedicine; Covid-19 epidemic; Glucose control

Outcome Measures

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.

  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will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist has been replaced by a teleconsultation due to the availability of diabetologists whose activity is focused on the management of Covid-19 negative patients.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.

  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.

  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.

  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.

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

• Results of patient satisfaction questionnaire.

  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.

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

Study Arms (2)

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.

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

Other: care modalities

Interventions

care modalities OTHER

For these patients the consultation has been postponed for 6 months. No specific intervention for this group of patient.

Group P: Diabetic patients with conventional follow-up

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

Group TC: Diabetic patients followed by Teleconsultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: May 4, 2020
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)