Clinical trials: Closed Loop
Type 1 Diabetes Mellitus
Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker
The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a…
- Trial name
- NCT01582139
- Testing
- Heart rate informed SSM+HMM
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
Diabetes Mellitus, Diabetes Mellitus, Type 1
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.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases
- Trial name
- DAN05 (NCT02925299)
- Testing
- FlorenceM (US) and FlorenceX (UK), Insulin pump therapy
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 133 people
- Sponsor
- Jaeb Center for Health Research
Type 1 Diabetes Mellitus
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.
- Trial name
- NCT03959423
- Testing
- AHCL insulin pump system
- Where
- 17 sites in United States
- Volunteers
- 288 people
- Sponsor
- Medtronic MiniMed, Inc.
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
Intraoperative Volume Status, Postoperative Complications
Closed-Loop Fluid Administration System Using Hemodynamic Monitors
The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid administration system to deliver fluids using feedback from standard operating room hemodynamic monitors.
- Trial name
- NCT02020863
- Testing
- Closed Loop
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, Irvine
Type 1 Diabetes Mellitus, Cognitive Change
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess…
- Trial name
- NCT03674281
- Testing
- SAP, CLC
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Virginia
Type1 Diabetes Mellitus
The Insulin-Only Bionic Pancreas Bridging Study
The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas.
- Trial name
- NCT03565666
- Testing
- iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog, iLet Bionic Pancreas insulin-only configuration with Fiasp, Usual care
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Massachusetts General Hospital
Type 1 Diabetes
Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes
The purpose of this feasibility study is to evaluate subject safety of using the Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the AHCL system in adult subjects with type 1 diabetes in a…
- Trial name
- NCT04964128
- Testing
- MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)
- Where
- Israel
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic MiniMed, Inc.
Chronic Disease, Diabetes Mellitus
Social Risk Score, Clinical Decision Support Tool and Closed Loop Referral for Social Risk Screen and Referral
The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged…
- Conditions
- Chronic Disease, Diabetes Mellitus, Hypertension, Congestive Heart Failure
- Trial name
- NCT05574699
- Testing
- Social Risk Score and CDS Tool, Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Type 1 Diabetes
Extended Bolus for Meals in a Closed-loop System
This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system.
- Trial name
- NCT05454891
- Testing
- Tandem t:slim X2 insulin pump: Extended bolus of insulin then standard bolus of insulin, Tandem t:slim X2 insulin pump: Standard bolus of insulin then extended bolus of insulin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, San Francisco
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.
Parkinson's Disease
Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease
Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs in Parkinson's disease. Currently, cDBS is limited to "open-loop" stimulation, without real-time adjustment to the patient's state of…
- Trial name
- aDBS (NCT02384421)
- Testing
- Adaptive DBS (Activa PC+S Neurostimulator), Continuous DBS (Activa PC+S Neurostimulator)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Stanford University
Diabetes Mellitus, Type 2
Closed Loop Glucose Control in Patients With Type 2 Diabetes
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting.
- Trial name
- NCT05386849
- Testing
- FUSION closed loop glucose control system
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ideal Medical Technologies
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
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 Mellitus
FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with…
- Trial name
- NCT03977727
- Testing
- Fiasp®, Novolog®, 670G hybrid closed loop continuous subcutaneous insulin infusion system
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Texas Diabetes & Endocrinology, P.A.
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting.
- Trial name
- NCT05644730
- Testing
- Fusion closed loop glucose control system
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ideal Medical Technologies
Diabetes Mellitus, Type 1
MiniMed™ 670G System China Study for Type I Diabetic
The purpose of this study is to obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China.
- Trial name
- NCT04663295
- Testing
- MiniMed™ 670G system
- Where
- 4 sites in China
- Volunteers
- 74 people
- Sponsor
- Medtronic MiniMed, Inc.
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
Wounds and Injuries, Respiratory Failure
FiO2 Closed Loop Control Ventilation
A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous…
- Trial name
- CLC (NCT02810080)
- Testing
- Closed Loop Control Ventilation, Manual Control Ventilation
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Zoll Medical Corporation