ECSPECT-HYPO trial
- Conditions
- Diabetes type 1, Hypoglycaemia, Impaired awareness of hypoglycemia, Continuous glucose monitoring, Psychoeducation.Diabetes type 1, Hypoglycaemie, Hypoproblematiek, Continue glucose monitoring, Psychoeducatie.
- Registration Number
- NL-OMON29063
- Lead Sponsor
- Vrije Universiteit Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 115
Inclusion Criteria
18 years or older
-Type 1 diabetes, treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI)
Exclusion Criteria
-Renal insufficiency, with glomerular filtration rate (GFR) < 30 mL/min
-History of myocardial infarction in the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of (self-reported) severe hypoglycemia
- Secondary Outcome Measures
Name Time Method Hypoglycemia awareness (Gold score); frequency of mild hypoglycemia; glycosylated hemoglobin (HbA1c); results from the diagnostic glucose sensor: time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), sensor-derived hypoglycaemic events, nocturnal hypoglycemia, area under curve (AUC) ¡Ü3.9 mmol/L and glucose variability; psychological well-being: fear of hypoglycemia (Hypoglycemia Fear Survey (HFS-II)), diabetes-related distress (PAID); quality adjusted life years (QALYs) and societal costs consisting of costs of healthcare consumption, informal care and lost productivity.