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)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: glucose control and sensor usage

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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of glucose management indicator (GMI) compared to before lockdown.	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	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	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	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	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.	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.	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.	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).

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Alfred PENFORNIS, MD PhD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: adolescent; COVID-19; telemedicine; type 1 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: IDRCB 2020-A02760-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No