NCT04384471

Brief Summary

Given the current situation with COVID-19 declared pandemic on March 11, 2020 and the requirement for physical distancing and to limit social interactions, and for some, to quarantine, the investigators will survey patients living with type 1 diabetes (and their families, if they are \<18 years) about their current experience with their diabetes management to understand their needs. The primary objective is to describe the exposition and the impact of COVID-19 pandemic on type 1 diabetes. The investigators will recruit people with type 1 diabetes from all ages living in Quebec to answer a short online survey.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

May 1, 2020

Last Update Submit

February 23, 2021

Conditions

Keywords

Patient reported outcomesType1diabetesCovid19

Outcome Measures

Primary Outcomes (1)

  • Self-reported acute diabetes complication

    Severe hypoglycemia and diabetic ketoacidosis

    Since March 11, 2020

Secondary Outcomes (6)

  • Self-reported hypoglycemia

    Last 7 days

  • Ability to get diabetes supplies and to access diabetes care

    Since March 11, 2020

  • Concern about not having access to diabetes supplies and to access diabetes care

    Since March 11, 2020

  • Impact of the pandemic situation on daily life activities

    Since March 11, 2020

  • Impact on stress, anxiety and depression for adults participants

    Last 2 weeks

  • +1 more secondary outcomes

Study Arms (1)

People living with Type 1 Diabetes

People from all ages living with type 1 diabetes in the Province of Quebec

Other: Online survey

Interventions

Participants are invited to answer an online questionnaire including both close-ended and open-ended questions about their experience during this sanitary crisis

People living with Type 1 Diabetes

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

-People living with type 1 diabetes in Quebec and are registered to the BETTER registry.

You may qualify if:

  • Having type 1 diabetes
  • Living in Quebec
  • Having took part in the BETTER registry (www.type1better.com)

You may not qualify if:

  • Not understanding French or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anne-Sophie Brazeau, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 12, 2020

Study Start

April 29, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations