Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02925299 · ClinicalTrials.gov registry record · NA
Day and Night Closed-loop in Young People With Type 1 Diabetes
A NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
- 11
- Study locations
NCT02925299 is a NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1 that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 131 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (93% lower). The trial reports 11 study locations across 9 states.
The verdict
NCT02925299, a NA study of Diabetes Mellitus and Diabetes Mellitus, Type 1, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
- 11
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (93% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
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.
NCT02925299 reports 11 study locations spanning 9 distinct geographic areas - top geographies include England, Other, California.
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.
What interventions are being tested in trial NCT02925299?
The interventions under investigation include: FlorenceM (US) and FlorenceX (UK) (DEVICE), Insulin pump therapy (DEVICE).
Who is sponsoring clinical trial NCT02925299?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Improving Glycemic Control With Telemedicine and Smart Insulin Pens
RECRUITING · NA
-
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
RECRUITING · NA
-
Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility
RECRUITING · NA
-
FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
RECRUITING · NA
-
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
RECRUITING · NA
-
Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.