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NCT04292509: ROKSANA
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy
NA trial testing SAP with stop before low in Pregnant Women With Type 1 Diabetes in 12 participants. Completed in 15 July 2020.
15 June 2020
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 12 |
| Start date | 15 February 2020 |
| Primary completion | 15 June 2020 |
| Estimated completion | 15 July 2020 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- SAP with stop before low
- SAP with stop on low
Conditions studied
- Pregnant Women With Type 1 Diabetes — all drugs for Pregnant Women With Type 1 Diabetes →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
Adults 18 to 45, female only, with Pregnant Women With Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The ROKSANA study is an open-label crossover RCT with the aim to evaluate whether sensor-augmented pump therapy (SAP) with predictive low glucose suspend technology is associated with an increased risk for ketonaemia during type 1 diabetes pregnancies.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
57<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes.
· 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y -
Risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy with predictive low glucose suspend compared with low glucose suspend: a crossover RCT.
Benhalima K, van Nes F, Laenen A, Gillard P, et al · · 2021 · cited 5× · PMID 34647140 · DOI 10.1007/s00125-021-05589-y
Verify or expand the search:
- PubMed search for NCT04292509
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04292509 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 30 September 2021
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/NCT04292509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing