Clinical trials: Closed-Loop
Epilepsy
Acute Recording of Stereotyped High-Frequency Oscillations
Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates >=1kHz and deliver…
- Trial name
- NCT05439655
- Testing
- Brain Interchange System
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
Type 1 Diabetes
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes.
- Trial name
- NCT01856790
- Testing
- ePID closed loop system, liraglutide
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Jennifer Sherr
Diabetes Type 2
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients.
- Trial name
- CLOSEAP+ (NCT04233229)
- Testing
- t:slim X2 with Control-IQ, home healthcare services, usual care for daily insulin treatment
- Where
- 10 sites in France
- Volunteers
- 43 people
- Sponsor
- Air Liquide Santé International
Type 1 Diabetes
Clinical Assessment of a Closed-loop System With Glucagon, Exercise and Mixed Meals
The diabetes technology group at Imperial College have developed a bio-inspired artificial pancreas (BiAP) system which uses a control algorithm based on a mathematical model of beta-cell physiology.
- Trial name
- NCT02397265
- Testing
- Bi-hormonal closed loop pump, Standard opened loop pump, Insulin closed loop
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- Imperial College London
Type 1 Diabetes
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.
- Trial name
- NCT04877730
- Testing
- Fully Closed Loop (FCL), Fully Closed Loop with meal anticipation module (FCL+), Hybrid Closed Loop (HCL)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Virginia
Type1 Diabetes
Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)
The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an…
- Trial name
- HY-GRAID (NCT04255381)
- Testing
- Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Yale University
Open Heart Surgery
Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery
With the advancement in microprocessor technology and better understanding of pharmacodynamics and pharmacokinetics of anaesthetic agents, computer facilitated closed loop control of anaesthesia using propofol has been shown to…
- Trial name
- NCT01069562
- Testing
- Conventional control, Closed loop control
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Low Back Pain, Leg Pain
Medtronic Closed-Loop Spinal Cord Stimulation System
The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.
- Conditions
- Low Back Pain, Leg Pain, Upper Limb Pain
- Trial name
- NCT05177354
- Testing
- Inceptiv
- Where
- 7 sites in Australia
- Volunteers
- 94 people
- Sponsor
- MedtronicNeuro
Cystic Fibrosis-related Diabetes
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children…
- Trial name
- NCT03258853
- Testing
- Bionic Pancreas, Usual Care
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Massachusetts General Hospital
Diabetes Mellitus, Type 1
Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes
The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device is already available for sale.
- Trial name
- NCT03816761
- Testing
- Fast-acting insulin aspart, iLet™
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Novo Nordisk A/S
Type 1 Diabetes Mellitus, Pregnancy in Diabetes
Pregnancy Intervention With a Closed-Loop System (PICLS) Study
In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia.
- Trial name
- PICLS (NCT03774186)
- Testing
- Hybrid closed-loop therapy, Sensor-augmented pump therapy
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- University of Colorado, Denver
Diabetes Mellitus, Type 1
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8…
- Trial name
- NCT02750267
- Testing
- Diabetes Assistant (DiAs) with Closed-Loop
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
Type 1 Diabetes
The International Diabetes Closed Loop (iDCL) Trial: Protocol 4
The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.
- Trial name
- DCLP4 (NCT04436796)
- Testing
- interoperable Artificial Pancreas System (iAPS), Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sansum Diabetes Research Institute
Type 1 Diabetes Mellitus
Glycemic Control and the Brain in Children With Type 1 Diabetes
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care.
- Trial name
- NCT03428932
- Testing
- Closed Loop (Medtronic 670G), Standard Care
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- Nemours Children's Clinic
Diabetes Mellitus, Type 1, Type 1 Diabetes
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and…
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Diabetes, Autoimmune, Diabetes type1
- Trial name
- NCT05168657
- Testing
- Bionic Pancreas, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- University of Colorado, Denver
Type 1 Diabetes Mellitus
Single Hormone Closed Loop Study With PDT Sensor
The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the…
- Trial name
- NCT03528174
- Testing
- Artificial Pancreas Control system (APC), Pacific Diabetes Technologies CGM Insulin Infusion system
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Oregon Health and Science University
Type 1 Diabetes
Feasibility Studies of Personalized Closed Loop
This is a single arm study comprised of a series of feasibility studies.
- Trial name
- NCT04203823
- Testing
- Cloud-based Digital Twin and Meal Prediction algorithms
- Where
- 12 sites in United States
- Volunteers
- 126 people
- Sponsor
- Medtronic MiniMed, Inc.
Overactive Bladder, Urinary Frequency
FREEOAB Study for Overactive Bladder
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
- Conditions
- Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
- Trial name
- NCT04547920
- Testing
- Wearable Bladder Modulation System
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- Avation Medical, Inc.
Diabetes Mellitus, Type 1 Diabetes
The Insulin-Only Bionic Pancreas Pivotal Trial
This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 1
- Trial name
- NCT04200313
- Testing
- Bionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp), Usual Care (UC)
- Where
- 16 sites in United States
- Volunteers
- 440 people
- Sponsor
- Jaeb Center for Health Research