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

Type 1 Diabetes Clinical Trial

— COVIDIABADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669912
• Other study ID #: IDRCB 2020-A02760-39
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: January 22, 2021

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).