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NCT03815487
Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)
NA trial testing Medtronic MiniMed 670G Insulin Pump in Auto Mode in Patient Care in 40 participants. Completed in 10 October 2020.
10 October 2020
Quick facts
| Lead sponsor | Kinderkrankenhaus auf der Bult |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 19 November 2018 |
| Primary completion | 10 October 2020 |
| Estimated completion | 10 October 2020 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Medtronic MiniMed 670G Insulin Pump in Auto Mode
- Medtronic MiniMed 670G Insulin Pump without Auto Mode
Conditions studied
- Patient Care — all drugs for Patient Care →
- Drug Therapy — all drugs for Drug Therapy →
Sponsor
Kinderkrankenhaus auf der Bult — full company profile →
Who can join
Adults 2 to 14, any sex, with Patient Care or Drug Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional effects compared to SAP therapy: according to actual and predicted sensor glucose values, the insulin therapy can be adopted automatically by pump: in case of high values (or predicted) more insulin will be administered, in case of low values (or predicted) the insulin infusion will be decreased a suspended and resumed again. So the HCL provides a lot more automatic functions to keep glucose in target compared to SAP. The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop glucose management in patients with type 1 diabetes at home.
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 NCT03815487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Patient Care
Currently open trials in the same condition.
- NCT06670612 — The Effect of Nature-Based Music Concert on Intensive Care Patients · NA · active not recruiting
Other Kinderkrankenhaus auf der Bult trials
Trials by the same sponsor.
- NCT04234867 — Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D) · Phase 1 · terminated
- NCT05118945 — Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update · completed
- NCT03815552 — Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth · NA · completed
- NCT02987738 — Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes · Phase 1 · 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 NCT03815487 (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 Kinderkrankenhaus auf der Bult
- Last refreshed: 16 June 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/NCT03815487.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing