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

November 6, 2020 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France
        • Hopitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Management of diabetic patients by telemedicine with a 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
For these patients the consultation has been postponed for 6 months. No specific intervention for this group of patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
HbA1C measured at 3 months post-telemedicine consultation group / post-cancellation of the face-to-face consultation group (variation versus basal)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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.
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.
This questionnaire is not a score on a scale, there is no minimum or maximum values.
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.
This questionnaire is not a score on a scale, there is no minimum or maximum values.
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 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).
Number of conventional hospitalizations, in intensive care and deaths during the study (6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7775

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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