Last reviewed · How we verify
NCT05812547
A Novel Device for Gestational Diabetes Control
NA trial testing Lumen in Gestational Diabetes Mellitus in 120 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | Rambam Health Care Campus |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 August 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 30 June 2026 |
Drugs / interventions tested
- Lumen
- Glucose monitoring mobile app
Conditions studied
- Gestational Diabetes Mellitus — all drugs for Gestational Diabetes Mellitus →
Sponsor
Rambam Health Care Campus — full company profile →
Who can join
Adults 18 to 45, female only, with Gestational Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in lifestyle or medication. Several studies have demonstrated the effectiveness of mobile apps in improving obstetric outcomes in GDM. In addition, the LUMEN device is a breathing device that produces dietary and exercise recommendations based on CO2 levels and improves metabolic parameters in patients with type 2 diabetes. No work has been done on its effectiveness in treating GDM. Aims of the study: Comparison of metabolic outcomes in women with gestational diabetes, with or without the use of LUMEN app. Design: This will be an open label parallel group 1:1 randomized-controlled trial Methods: the investigators will recruit women diagnosed with GDM. The women will be randomized to the intervention arm that will use the LUMEN device and app or to the control arm that will use a free mobile tracking app. The women will be required to monitor their blood sugar levels daily and to have GDM follow-up in the feto-maternal outpatient clinic, as is customary in GDM. After the birth, the maternal and neonatal outcome will be recorded. Based on past research data, a recruitment of 170 is needed to demonstrate a 16.7% decrease in insulin use to balance diabetes, with α = 0.05 and β = 80.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05812547
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gestational Diabetes Mellitus
Currently open trials in the same condition.
- NCT06997835 — The Role of Early Nursing Intervention in the High-risk Population of Gestational Diabetes · NA · active not recruiting
- NCT06648174 — The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus · NA · recruiting
- NCT06436326 — The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes · NA · recruiting
- NCT05852054 — Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP) · Phase 3 · active not recruiting
- NCT05800509 — Gestational Diabetes and Perinatal Depression: an Intervention Program · NA · recruiting
Other Rambam Health Care Campus trials
Trials by the same sponsor.
- NCT07384013 — Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs · NA · recruiting
- NCT06688253 — Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis · Phase 4 · not yet recruiting
- NCT06235749 — Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery · NA · recruiting
- NCT06622902 — Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants. · NA · recruiting
- NCT05922111 — Cervical Ripening Balloon for 12 Hours vs. 1 Hour. · NA · not yet recruiting
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 NCT05812547 (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 Rambam Health Care Campus
- Last refreshed: 22 June 2023
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/NCT05812547.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing