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

NCT04669912 | Completed

• 1 other identifier: 2020-A02760-39
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; adolescent; COVID-19; telemedicine

Outcome Measures

Primary Outcomes (3)

• Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before 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

  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

  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)

Secondary Outcomes (8)

• Evolution of glucose management indicator (GMI) compared to before lockdown.

  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

  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

  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

  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

  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).

Interventions

glucose control and sensor usage OTHER

Data related to glucose control and sensor usage collected from the Libreview platform

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; COVID-19

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alfred PENFORNIS, MD PhD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: January 15, 2021
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)