Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Day and Night Closed-loop in Young People With Type 1 Diabetes
NCT02925299 · View on ClinicalTrials.gov ↗
Study Summary
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group). It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy. Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).
Conditions Studied
Interventions
- DEVICE FlorenceM (US) and FlorenceX (UK)
- DEVICE Insulin pump therapy
Study Locations (11)
England
- Nottingham Children's Hospital — Nottingham
- Southampton Children's Hospital — Southampton
Other
- Alder Hey Children's NHS Foundation Trust — Liverpool
- Oxford Children's Hospital — Oxford
California
- Stanford University — Palo Alto
Colorado
- University of Colorado Denver School of Medicine Barbara Davis Center — Aurora
Connecticut
- Yale University — Hartford
Florida
- Nemours Children's Health System — Jacksonville
Indiana
- Indiana University — Indianapolis
Cambridgeshire County
- University of Cambridge — Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2017-05-12 |
| Est. Completion | 2020-08-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02925299
The ClinicalTrials.gov registry entry for NCT02925299 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions — of which FlorenceM (US) and FlorenceX (UK) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02925299 reports 11 study locations spanning 9 distinct geographic areas — top geographies include England, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02925299 about?
NCT02925299 is a clinical study titled "Day and Night Closed-loop in Young People With Type 1 Diabetes". The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6...
What is the current status of trial NCT02925299?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2017-05-12. Estimated completion is 2020-08-27.
What conditions does trial NCT02925299 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Autoimmune Diseases, Glucose Metabolism Disorders, Endocrine System Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02925299?
The interventions under investigation include: FlorenceM (US) and FlorenceX (UK) (DEVICE), Insulin pump therapy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02925299?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02925299 being conducted?
This trial has 11 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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