Clinical Trials Logo

Clinical Trial Summary

The main objective of this study is to determine the feasibility, efficacy and safety of automated closed-loop glucose control in the home setting over a short term period. The data and experienced gained from this study will be utilised in planning future home studies.

This is an open-label, three centre, randomised, crossover design, involving two, 8 day (first day in the clinical research facility and seven days at home) study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects usual insulin pump therapy in random order. A total of up to 24 adults (aiming for 18 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. During the 24 hour in-patient stay subjects will be encouraged to mimic their usual day and will be allowed to walk inside hospital premises. Subjects will be advised to discontinue automated closed-loop insulin delivery and follow their usual insulin pump therapy for periods of strenuous exercise during the 7 day home study phase.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics, and for the stay at the clinical research facility, time spent in the target range, above and below the target range as measured by plasma glucose.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01666028
Study type Interventional
Source University of Cambridge
Contact
Status Completed
Phase Phase 2
Start date November 2012
Completion date November 2013

See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02914886 - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Phase 4
Completed NCT02897557 - Insulet Artificial Pancreas Early Feasibility Study N/A