Status:
UNKNOWN
Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
HypoResolve
Conditions:
Diabetes type1
Eligibility:
All Genders
16+ years
Brief Summary
Rationale: Hypoglycaemia is the most frequent complication of insulin treatment in individuals with type 1 diabetes and a limiting factor for achieving optimal glycaemic control. When recurrent, hypo...
Eligibility Criteria
Inclusion
- Type 1 diabetes diagnosis based on clinical judgement with or without auto-antibodies, according to the ISPAD Clinical Practice Consensus Guidelines 2018 (27). Briefly, clinical criteria for the diagnosis of diabetes mellitus include an acute presentation, classical symptoms of diabetes or profound hyperglycaemia with or without ketoacidosis, a plasma glucose concentration ≥11.1 mmol/L and considerably elevated HbA1c, and age of onset \>6 months.
- Age ≥16 years.
- Ability to provide written informed consent.
- Fluency in speaking and reading Dutch.
Exclusion
- Severe psychiatric comorbidity that leads to inability to provide informed consent or as judged by the healthcare provider
- Other comorbidity interfering with completing surveys, as judged by the healthcare professional.
Key Trial Info
Start Date :
January 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04311021
Start Date
January 23 2020
End Date
February 1 2021
Last Update
March 17 2020
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands