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
Condition: Type 1 Diabetes
MeSH terms: COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): glucose control and sensor usage
Intervention type(s): Other
Intervention description(s): Data related to glucose control and sensor usage collected from the Libreview platform
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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.
      
Keywords: type 1 diabetes; adolescent; COVID-19; telemedicine