Status:
COMPLETED
Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Collaborating Sponsors:
Regione Emilia-Romagna
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Brief Summary
Diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease. Self-monitoring of blood glucose (SM...
Detailed Description
Patients will be identified and enrolled in the Diabetes Departments of different hospitals/clinics in the Emilia Romagna region, Italy. Patients will be divided in two groups A (naive patients,) and ...
Eligibility Criteria
Inclusion
- Diagnosis of Diabetes Mellitus type 1 for at least 12 months
- Multi-injection insulin therapy
- C-peptide \<0.2 nmol/L
- At least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement).
Exclusion
- Diabetes Mellitus type 2
- Other types of diabetes
- Other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system.
Key Trial Info
Start Date :
May 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04060732
Start Date
May 5 2017
End Date
December 30 2020
Last Update
January 13 2021
Active Locations (1)
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1
Azienda Ospedaliero Universitaria
Parma, Italy, 43100