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NCT03414320: POC-IDENTITY-1

Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes

Completed NA Last updated 2 August 2018
What this trial tests

NA trial testing Gathering data in Type1 Diabetes Mellitus in 21 participants. Completed in 12 July 2018.

Timeline
11 January 2018
Primary endpoint
12 July 2018
12 July 2018

Quick facts

Lead sponsorUniversitaire Ziekenhuizen KU Leuven
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment21
Start date11 January 2018
Primary completion12 July 2018
Estimated completion12 July 2018
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 18 to 65, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 computing the carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF), which are the main parameters of bolus calculators. The present study is a proof-of-concept, open label, single arm clinical trial to validate the new method and refine both the mathematical model and the numerical techniques in well-regulated and disciplined type 1 diabetic subject. The study is a "trial" of the selected underlying mathematical model and the associated algorithms to simulate the glucose values of a patient with uncertain meal-data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Type1 Diabetes Mellitus

Currently open trials in the same condition.

Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03414320.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing