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Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes (POC-IDENTITY-1) 21 Open-Label

Completed
Clinical Trial NCT03414320 (POC-IDENTITY-1) was an interventional study for Type1 Diabetes Mellitus that is now completed. The study started on 11 January 2018, with plans to enroll 21 participants. Led by Universitaire Ziekenhuizen KU Leuven, the expected completion date was 12 July 2018. The latest data from ClinicalTrials.gov was last updated on 2 August 2018.
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 parameters based on current automatic electronic logbooks of glucose measurements, carbohydrate intake, and insulin usage, by means of a mathematical model. More specifically, the investigators are interested in computi...Show More
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 the CGM sensor as well as on the bolus calculator (BC). The study will take three weeks (or three sensors) per patient.

Patients should live a close to normal life and should participate in their normal daily activities....

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Official Title

Proof of Concept Study for the Identification of Patient-specific Parameters for Bolus Calculators in Type 1 Diabetic Patients

Conditions
Type1 Diabetes Mellitus
Other Study IDs
  • POC-IDENTITY-1
  • BolusCalc
NCT ID Number
NCT03414320
Start Date (Actual)
2018-01-11
Last Update Posted
2018-08-02
Completion Date (Estimated)
2018-07-12
Enrollment (Estimated)
21
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
type 1 diabetes
insulin pump
bolus calculator
continuous glucose monitoring
carbohydrate to insulin ratio
insulin sensitivity factor
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalStudy Arm
We will gather data from this group of patients.
Gathering data
Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Accepting mathematical model
The primary outcome measure will be to accept or reject the mathematical model by calculating mean-squared error differences with the data.
three weeks
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Universitaire Ziekenhuizen KU Leuven logoUniversitaire Ziekenhuizen KU Leuven
Study Responsible Party
prof dr Pieter Gillard, Principal Investigator, Principal Investigator, Universitaire Ziekenhuizen KU Leuven
No contact data.
1 Study Locations in 1 Countries
UZ Leuven, Leuven, 3000, Belgium