Status:
COMPLETED
Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
KU Leuven
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The adoption of bolus calculators has been limited by the slow speed of the current trial and error approach. The goal of this project is to automate the determination of patient specific insulin pump...
Detailed Description
After signing informed consent and checking eligibility criteria participants will receive uniform education related to self-monitoring of blood glucose and continuous glucose monitoring (CGM) using t...
Eligibility Criteria
Inclusion
- Signed informed consent
- Patient followed at the endocrinology department of UZ Leuven
- Type 1 diabetes
- Treated with subcutaneous insulin pump (CSII) for more than 12 weeks
- Using a continuous glucose monitor (CGM) for more than 12 weeks
- No known diabetic gastroparesis
- C-peptide negative
- HbA1c between 6-10%
- Using, or willing to use, the bolus calculator
Exclusion
- Type 2 diabetes, patients with secondary diabetes
- Patients treated with multiple daily insulin injections or begin of treatment with CSII less than 12 weeks before inclusion
- Known diabetic gastroparesis
- C-peptide positive
- HbA1c \< 6% or \> 10%
- Not using or not willing to use the bolus calculator
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03414320
Start Date
January 11 2018
End Date
July 12 2018
Last Update
August 2 2018
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000