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NCT03414320: POC-IDENTITY-1
Proof of Concept - Identification of Patient-specific Parameters for Bolus Calculators for Type 1 Diabetes
NA trial testing Gathering data in Type1 Diabetes Mellitus in 21 participants. Completed in 12 July 2018.
12 July 2018
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 21 |
| Start date | 11 January 2018 |
| Primary completion | 12 July 2018 |
| Estimated completion | 12 July 2018 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Gathering data
Conditions studied
- Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →
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:
- PubMed search for NCT03414320
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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Currently open trials in the same condition.
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- NCT03811470 — China Diabetes Registry by Metabolic Management Center · recruiting
Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03414320 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 2 August 2018
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