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

NCT ID: NCT04669912

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-01-22

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

glucose control and sensor usage

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred PENFORNIS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

IDRCB 2020-A02760-39

Identifier Type: -

Identifier Source: org_study_id