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Study of the Effect of Telemedicine on Glycemic Control for Patients With Diabetes and Treated With Insulin (TLS-DIAB)

17 juni 2021 uppdaterad av: Centre Hospitalier Sud Francilien

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

64

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Corbeil-essonnes Cedex, Frankrike, 91106
        • Centre Hospitalier Sud Francilien

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

insulin-treated diabetic patients

Beskrivning

Inclusion Criteria:

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.

Exclusion Criteria:

  • patients objecting to research

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
glycated hemoglobin
Tidsram: at 3 months
glycated hemoglobin
at 3 months
glycated hemoglobin
Tidsram: at 6 months
glycated hemoglobin
at 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
glycated hemoglobin
Tidsram: at 3 months
time spent in the target
at 3 months
glycated hemoglobin
Tidsram: at 6 months
time spent in the target
at 6 months
Time above target (TAR)
Tidsram: at 3 months
Change in time above target (TAR) of hyperglycemia, > 250 mg/dL, from 181 to 250 mg/dL
at 3 months
Time above target (TAR)
Tidsram: at 6 months
Change in time above target (TAR) of hyperglycemia, > 250 mg/dL, from 181 to 250 mg/dL
at 6 months
Time spent below target (TBR)
Tidsram: at 3 months
Change in time spent below target (TBR) of hypoglycemia from 54 to 69 mg/dL and < 54 mg/dL
at 3 months
Time spent below target (TBR)
Tidsram: at 6 months
Change in time spent below target (TBR) of hypoglycemia from 54 to 69 mg/dL and < 54 mg/dL
at 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 maj 2021

Primärt slutförande (Faktisk)

8 juni 2021

Avslutad studie (Faktisk)

8 juni 2021

Studieregistreringsdatum

Först inskickad

6 maj 2021

Först inskickad som uppfyllde QC-kriterierna

11 maj 2021

Första postat (Faktisk)

12 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2021

Senast verifierad

1 juni 2021

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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Kliniska prövningar på continuous glucose monitoring

3
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