Hypoglycemia unawareness Hypoglycemia unawareness
Conditions
Interventions
Abbott FreeStyle Libre Pro IQ and FreeStyle Libre 2 Plus Continuous Glucose Monitoring Systems
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Carrier of CDH1 pathogenic germline variant
Exclusion criteria
Exclusion criteria: Mental incompetence Taking more than 1000 mg of Vitamin C per day and unwilling or unable to discontinue (as judged by the PI) Diabetes mellitus Use of corticosteroids or other medication that influences blood glucose levels Proven allergy to the Freestyle Libre 2 plus device Not able or not willing to download the necessary apps on a mobile phone Not able or not willing to applicate the CFGM pad Pregnant women Severely ill participants Participants requiring dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoint is the number of hypoglycemic episodes per day, defined as a glucose level of < 3.3 mmol/l. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are the depth and duration of these hypoglycemic episodes, the association of CFGM detected hypoglycemia with patient-reported hypoglycemia-related symptoms and the correlation with meal timing and estimated carbohydrate intake, number and height of hyperglycemic episodes per day, with hyperglycemia defined as glucose >10.0 mmol/l, association between hyperglycemia and symptoms, association between hyperglycemic and hypoglycemic episodes, evaluation of glucose variability (? glucose) and estimation of HbA1c (eA1c) from CGM data. | — |
Countries
Netherlands
Contacts
Public ContactT.M. Bisseling
Radboud Universitair Medisch Centrum
Outcome results
None listed