Clinical trials: Closed-Loop
Diabetes Mellitus, Type 1
Assessment of an Automatic Closed-loop Insulin Delivery System
The overall aim of this research proposal is to determine the safety, feasibility and efficacy of an automatic closed-loop insulin delivery system.
- Trial name
- NCT02366767
- Testing
- Automatic closed-loop insulin delivery, Control
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Stanford University
Stroke
taVNS for Upper Limb Rehabilitation
This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear.
- Trial name
- NCT04129242
- Testing
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
Diabetes Mellitus, Type 1
Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.
- Trial name
- NCT01973413
- Testing
- Diabetes Assistant (DiAs), Tandem t:slim Insulin Pump, Dexcom G4 Platinum sensor
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Virginia
Essential Tremor
Wearable Sensor for Responsive DBS for ET
The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography…
- Trial name
- NCT03051178
- Testing
- Responsive deep brain stimulation
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- University of Florida
Type 1 Diabetes
Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide
The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide.
- Trial name
- NCT06422325
- Testing
- MPC closed-loop system in insulin only mode, MPC closed-loop system in insulin/pramlintide mode
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Oregon Health and Science University
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Type 1 Diabetes
Two Way Crossover Closed Loop Study MPC vs FMPD
An artificial pancreas (AP) is a control system for automatic insulin delivery. Our group has implemented a fading memory proportional derivative controller (FMPD) for use within an AP control system which has been evaluated in…
- Trial name
- NCT04771403
- Testing
- FMPD AP algorithm, MPC AP system, Dexcom G6 Continuous Glucose Monitoring (CGM) System
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oregon Health and Science University
Type 1 Diabetes
Two Way Crossover Closed Loop Study R-AP vs MPC
An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system.
- Trial name
- NCT05083559
- Testing
- MPC AP algorithm, Robust R-AP algorithm
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Oregon Health and Science University
Type 1 Diabetes
Effect of Gain on Closed-Loop Insulin
The purpose of this study is to test the ability of an advanced external Physiologic Insulin Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem) to get acceptable meal responses over a range…
- Trial name
- NCT02065895
- Testing
- HIGH error, NO error, LOW error
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Joslin Diabetes Center
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Type 1 Diabetes
Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®
This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.
- Trial name
- NCT05325294
- Testing
- MiniMed 780G System
- Where
- 19 sites in United States
- Volunteers
- 244 people
- Sponsor
- Medtronic MiniMed, Inc.
Type1 Diabetes Mellitus
The International Diabetes Closed Loop (iDCL) Trial: Protocol 1
The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.
- Trial name
- iDCL (NCT02985866)
- Testing
- Artificial Pancreas, Sensor Augmented Therapy
- Where
- 7 sites in United States
- Volunteers
- 127 people
- Sponsor
- University of Virginia
Diabetes type1
Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
SATURN study aims at evaluating Home Healthcare Provider (HHP) Management of type 1 diabetic patients using a closed-loop automatic insulin delivery system (or artificial pancreas), and specifically satisfaction and interactions…
- Trial name
- SATURN (NCT04635280)
- Testing
- any closed-loop automatic insulin delivery system (or artificial pancreas) European Conformity (CE)-marking
- Where
- 2 sites in France
- Volunteers
- 35 people
- Sponsor
- Air Liquide Santé International
Parkinson Disease
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop…
- Trial name
- NCT04043403
- Testing
- Open Loop DBS, Adaptive (Closed Loop) DBS, Intermittent Open Loop DBS
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Type 1 Diabetes
Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery
The purpose of this study is to understand the impact of the automated priming boluses on the safety and feasibility of a new fully automated AP controller.
- Trial name
- Rocket-BPS (NCT05528770)
- Testing
- FCL+BPS, FCL
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Marc Breton
Type 1 Diabetes, Hypoglycemia
Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.
- Trial name
- HYPOAVOID (NCT05379686)
- Testing
- GlucaGen
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Steno Diabetes Center Copenhagen
Pediatric Cardiac Surgery, Intraoperative Awareness
Closed Loop Propofol Administration in Pediatric Cardiac Surgery
The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual control using bispectral index in paediatric…
- Conditions
- Pediatric Cardiac Surgery, Intraoperative Awareness, Automated Drug Delivery
- Trial name
- NCT01600287
- Testing
- IAADS, Manual propofol administration
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Type1diabetes, Hypoglycemia Unawareness
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month…
- Conditions
- Type1diabetes, Hypoglycemia Unawareness, Nocturnal Hypoglycemia, Hypoglycemia Night
- Trial name
- Aim2 (NCT03215914)
- Testing
- MiniMed 670G system
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- University of Pennsylvania
Type 1 Diabetes
Real-life Data From Diabetic Patients on Closed-loop Pumps
To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.
- Trial name
- BLOOM (NCT05418699)
- Testing
- closed-loop insulin pump
- Where
- 5 sites in France
- Volunteers
- 410 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Type 1 Diabetes
The Pediatric Artificial Pancreas Automated Initialization Trial
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments…
- Trial name
- PEDAP-AI (NCT06017089)
- Testing
- AI-based Advisor system
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Marc Breton