Hb A1C Pre and Post Confinement in Latin American Children With Type 1 Diabetes: Dulce Study Group
1 other identifier
observational
500
1 country
1
Brief Summary
A multicenter retrospective observational study among children with type 1 diabetes will be performed. The Objective of this study will be to determine a) the association between the increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic. b) the association between the frequency of patient care during social confinement and the Hba1c values. Different centers from Latin America including Argentina, Peru, Panama, Chile, and Ecuador will participate in this study. Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of the participating centers will be collected on the Hb A1c value before and after confinement (6 months completed). The initial (base) value will be taken as a value of HbA1c registered in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine (Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have been performed in the same institution or with the same methods in order to avoid bias.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
November 17, 2020
CompletedStudy Start
First participant enrolled
November 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2021
CompletedNovember 23, 2020
November 1, 2020
4 months
November 17, 2020
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hb A1C pre and post Confinement in Latin American children with Type 1 Diabetes
The increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic
six months
Study Arms (1)
Patient with type 1 diabetes
Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included.
Eligibility Criteria
A multicenter retrospective observational study among children with type 1 diabetes will be performed. Different centers from Latin America including Argentina, Peru, Panama, Chile, and Ecuador will participate in this study. Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of the participating centers will be collected on the Hb A1c value before and after confinement (6 months completed). The initial (base) value will be taken as a value of HbA1c registered in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine (Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have been performed in the same institution or with the same methods in order to avoid bias.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Valeria Hirschler
Buenos Aires, 1006, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2020
First Posted
November 23, 2020
Study Start
November 22, 2020
Primary Completion
March 22, 2021
Study Completion
April 22, 2021
Last Updated
November 23, 2020
Record last verified: 2020-11