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NCT04126759
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
NA trial testing P0.3 in Diabetes Mellitus in 15 participants. Completed in 31 January 2020.
31 January 2020
Quick facts
| Lead sponsor | RSP Systems A/S |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 15 |
| Start date | 1 July 2019 |
| Primary completion | 31 January 2020 |
| Estimated completion | 31 January 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- P0.3
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
RSP Systems A/S
Who can join
Adults 18 to 40, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
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 NCT04126759
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other RSP Systems A/S trials
Trials by the same sponsor.
- NCT05851469 — Study of a Non-invasive Glucose Measuring Device · NA · completed
- NCT04518813 — A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings · NA · completed
- NCT04060693 — Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin · NA · withdrawn
- NCT03782441 — Study of a Novel Non-invasive Glucose Monitoring Device · NA · completed
- NCT04033042 — Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions f · NA · completed
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 NCT04126759 (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 RSP Systems A/S
- Last refreshed: 8 October 2020
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/NCT04126759.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing