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DiabetesTLS-DIABNCT04883372

Study of the Effect of Telemedicine on Glycemic Control for Patients With Diabetes and Treated With Insulin

An observational study of Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess glycemic control changes in insulin-treated patients with diabetes using a continuous glucose monitoring CGM system through the ETAPES telemedicine program. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Diabetes
What is being tested?
continuous glucose monitoring
How many people
64 participants
Where
1 siteFrance
Study dates
22 May 2021to 8 Jun 2021
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: insulin-treated diabetic patients

Who may be able to join

  • For people with T1D, inclusion criteria in the ETAPES program were:
  • new onset diabetes (< 6 months) or diabetes duration > 6 months with HbA1C ≥ 8% twice over the last 6 months in people aged over 18 years
  • new onset diabetes (< 6 months) or diabetes duration > 6 months with HbA1C ≥ 8.5% twice over the last 6 months in people aged between 12 and 17 years.
  • For people with T2D, inclusion criteria were diabetes duration > 12 months with HbA1C ≥ 9% twice over the last 6 months in people aged over 18 years.

Who cannot join

  • patients objecting to research

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

Other trials in France

About this study

Official title: Assessment of the Impact of Telemedicine in Insulin-dependent Diabetic Patients Through the ETAPES Program.

The purpose of this study is to assess glycemic control changes in insulin-treated patients with diabetes using a continuous glucose monitoring CGM system through the ETAPES telemedicine program.

Read the detailed description

Diabetes is currently one of the major health challenges. According to the International Diabetes Federation (IDF), the number of people with diabetes has tripled in the last 20 years and will reach 463 million cases in 2020. This chronic disease causes degenerative complications that affect the quality of life of patients and increase the morbidity and mortality rate. This is due to limited access to health professionals, inadequate patient education and especially poor self-management of their disease which hinders adequate glycemic control of diabetes. The daily routine of a type 1 diabetic patient includes self-monitoring of blood glucose levels as well as several insulin injections per day or the use of an insulin pump. However, this treatment does not prevent the occurrence of micro and/or macroangiopathic complications, especially when the diabetes is poorly controlled. Therefore, optimal and large-scale glycemic control can have a significant clinical, social and economic impact. The Diabetes Control and Complications Trial (DCCT) has shown that intensive glycemic control delays or prevents the occurrence of microvascular and macrovascular complications. Intensive treatment, education and support for diabetes self-management improves glycated hemoglobin levels, reducing the risk of developing degenerative complications. This is accompanied by a positive psychosocial and behavioral effect. It is in this context that telemedicine, via remote monitoring, can improve glycemic control. Diabetes remains one of the most suitable specialties for telemedicine, especially with the advent of continuous glucose measurements reimbursed by health insurance since 2017.

Since the 1990s, several telemonitoring projects have demonstrated the value of constant support for diabetic patients, resulting in a significant improvement in HbA1c; the patient becomes an actor in his or her management, with better appropriation of the disease and better compliance. Remote monitoring is one of the 5 telemedicine procedures defined in France. It allows a medical professional to remotely interpret the data necessary for a patient's medical follow-up and to make decisions regarding the patient's care.

The French health authorities have set up national experiments on remote monitoring of diabetes under real conditions, such as the ETAPES program, whose objective is to evaluate the clinical, medico-economic and quality of life benefits of patients who benefit from remote monitoring. This program has 3 components: remote medical monitoring of patients including remote interpretation of patient results and adaptation of treatment, therapeutic support through face-to-face or remote sessions and the use of a remote monitoring platform that provides the link between the patient and the medical team.

In December 2019, the endocrinology department of the CHSF decided to implement the ETAPES program via the LIBREVIEW technical solution in order to better support unbalanced insulin-treated diabetic patients.

Conditions
Diabetes
Being tested
continuous glucose monitoring
Keywords
Telemedicine, telemonitoring, diabetes, continuous glucose monitoring
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous glucose monitoringOther

    a continuous glucose monitoring CGM system through the ETAPES telemedicine program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. glycated hemoglobin

    glycated hemoglobin

    Measured: at 3 months

  2. glycated hemoglobin

    glycated hemoglobin

    Measured: at 6 months

Secondary outcomes (6)
  1. glycated hemoglobin

    time spent in the target

    Measured: at 3 months

  2. glycated hemoglobin

    time spent in the target

    Measured: at 6 months

  3. Time above target (TAR)

    Change in time above target (TAR) of hyperglycemia, > 250 mg/dL, from 181 to 250 mg/dL

    Measured: at 3 months

  4. Time above target (TAR)

    Change in time above target (TAR) of hyperglycemia, > 250 mg/dL, from 181 to 250 mg/dL

    Measured: at 6 months

  5. Time spent below target (TBR)

    Change in time spent below target (TBR) of hypoglycemia from 54 to 69 mg/dL and < 54 mg/dL

    Measured: at 3 months

  6. Time spent below target (TBR)

    Change in time spent below target (TBR) of hypoglycemia from 54 to 69 mg/dL and < 54 mg/dL

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start22 May 2021
  3. Primary completion8 Jun 2021
  4. Study completion8 Jun 2021

Resources

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
Retrospective
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883372
Sponsor's protocol ID
2021/0013
Acronym
TLS-DIAB
Status last verified
Jun 2021
First submitted
6 May 2021
Last updated
18 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Centre Hospitalier Sud Francilien 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 1 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 18 Jun 2021. 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?

glycated hemoglobin (time frame: at 3 months). The study lists 2 primary outcomes in all. 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 18 Jun 2021.

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