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COVID-19 Pandemic Lockdown Effect in Adolescents and Young Adults With Type 1 Diabetes: Positive Results of an Unpreceded Challenge for Telemedicine and Patient Self-management (COVIDIABADO)

21. května 2026 aktualizováno: Centre Hospitalier Sud Francilien

Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.

Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage.

The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform.

The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Continuous glucose monitoring (CGM) data will be collected from the cloud-based platform, LibreView.

Data will be collected for patients from Sud-Francilien hospital (Corbeil-Essonnes, France) and Kremlin-Bicêtre hospital (Kremlin-Bicêtre, France). Data related to glucose control and sensor usage will be collected from the Libreview platform. Data related to patients' characteristics, treatment and telemedicine visits (number of contacts with health professionals) will be collected from the medical record and confirmed with telephone-administered questionnaire.

The lockdown imposed by the French government occurred from March 17 to May 10, 2020. Therefore, outcomes will be assessed 4 times: the month before lockdown, during the first month, the second month of lockdown, and one month after lockdown ended.

Potential confounding factors will be studied: age, gender, type of insulin delivery (multiple daily injections, MDI; insulin pump), contacts with health professionals (physician or nurse).

Descriptive statistics will include means with standard deviations, numbers of patients and percentages.

Outcomes will be analysed with a linear mixed-effects regression model. Analyses will be performed with R studio version 3.5.0.

Typ studie

Pozorovací

Zápis (Aktuální)

77

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
    • France
      • Corbeil-Essonnes, France, Francie, 91100
        • Centre Hospitalier Sud Francilien

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

13 let až 25 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

The population will be selected from two university general hospitals of the region of Ile de France (France): Kremlin-Bicetre hospital and Sud-Francilien hospital.

The population will be aged from to 13 to 25 years at the beginning of lockdown.

Popis

Inclusion Criteria:

  • Type 1 diabetes
  • Age between 13 and 25 years
  • use of a flash glucose monitoring related to the LibreView cloud platform
  • patients follow-up by the diabetes department of Hopital Sud Francilien or the diabetes department of Hôpital Bicêtre.
  • patient informed of the study and not having objected to it.

Exclusion Criteria:

  • patients out of France during lockdown
  • other type of diabetes
  • Duration of diabetes of less than one year
  • patient aged under 13 years or above 26 years old

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown
Časové okno: Measure repeated 2 times : month before lockdown (28 days), after lockdown
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 2 times : month before lockdown (28 days), after lockdown
Changes in percentage of time spent in range 70-180 mg/dL during first month of lockdown compared to before lockdown
Časové okno: Measure repeated 2 times : month before lockdown (28 days), first month of lockdown (28 days)
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 2 times : month before lockdown (28 days), first month of lockdown (28 days)
Changes in percentage of time spent in range 70-180 mg/dL during second month of lockdown compared to before lockdown
Časové okno: Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Evolution of glucose management indicator (GMI) compared to before lockdown.
Časové okno: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using continuous glucose monitoring data collected on Libreview.
Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range <54 mg/dL
Časové okno: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range 54 - 70 mg/dL
Časové okno: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range 180-250 mg/dL
Časové okno: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range > 250 mg/dL
Časové okno: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of average glucose in mg/dL compared to before lockdown.
Časové okno: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Average glucose level in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of hypoglycaemia frequency compared to before lockdown.
Časové okno: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Number of hypoglycaemia events (glycemia under 70 mg/dL during at least 15 minutes) in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose sensor use compared to before lockdown.
Časové okno: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
The level of glucose data collected related to the glucose monitoring frequency and the number of scans with continuous glucose monitoring data collected on Libreview.
Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Centre Hospitalier Sud Francilien

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alfred PENFORNIS, MD PhD, Centre Hospitalier Sud Francilien

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. ledna 2021

Primární dokončení (Aktuální)

22. ledna 2021

Dokončení studie (Aktuální)

22. ledna 2021

Termíny zápisu do studia

První předloženo

7. prosince 2020

První předloženo, které splnilo kritéria kontroly kvality

15. prosince 2020

První zveřejněno (Aktuální)

17. prosince 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2020-A02760-39

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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