Status:
UNKNOWN
Novel Method of Pancreatic Islet Transplantation Into the Omentum
Lead Sponsor:
Frantisek Saudek
Conditions:
Islets of Langerhans Transplantation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators propose to conduct a pilot clinical study in 10 type 1 diabetic subjects suffering from hypoglycemia unawareness syndrome and episodes of severe hypoglycemia, in which therapy with t...
Detailed Description
Despite continuing progress in pharmacological insulin substitution, insulin administration and monitoring of glucose levels, type 1 diabetes has been still associated with specific late organ complic...
Eligibility Criteria
Inclusion
- Age 20 to 65 years, ability to comply with the procedures of the study protocol.
- Clinical history of type 1 diabetes with onset at \< 40 years of age, insulin-dependence for \> 5 years at the time of enrollment.
- Absent stimulated C-peptide (\<0,3 ng/l) in response to mixed meal test measured at 60 and 90 minutes after the start of consumption.
- Involvement in intensive diabetes management, defined as self-monitoring of glucose values no less that mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or in-sulin pump. Management under the direction of a diabetologist with at least 3 clin¬ical evaluations during the12 months prior to study enrollment.
- At least on episode of severe hypoglycemia in the 12 months prior to the study enrollment
- Reduced awareness of hypo glycaemia (as specified in detail in the full protocol) during the screening period OR marked glycemic lability characterized by wide swings in blood glucose despite optimal diabetes therapy
Exclusion
- Body Mass Index (BMI) \>30 kg/m2 or patient weight ≤50 kg.
- Insulin requirement of \>1.0 IU/kg/day or \<15 U/day.
- glomerular filtration rate \<80 mL/min/1.73 m2
- Additional exclusion criteria specified in the full protocol
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04884633
Start Date
August 15 2019
End Date
August 31 2023
Last Update
August 31 2021
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine, Department of Diabetes
Prague, Czechia, 14021