Clinical trials: Artificial Pancreas
Type 1 Diabetes Mellitus
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
- Trial name
- DCLP3 (NCT03563313)
- Testing
- t:slim X2 with Control-IQ Technology & Dexcom G6 CGM, Sensor-augmented pump (SAP)
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- University of Virginia
Diabetes Mellitus
Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas
The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.
- Trial name
- CL2 (NCT01161862)
- Testing
- Bi-hormonal (insulin and glucagon) artificial pancreas
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Boston University Charles River Campus
Diabetes Mellitus, Type 1
The Bio-Inspired Artificial Pancreas for the Home
The purpose of the study is to evaluate the safety and effectiveness of a closed-loop insulin delivery system (also known as an artificial pancreas) which is made up of three components that communicate with each other: 1.
- Trial name
- BiAP@home (NCT03740698)
- Testing
- BiAP, ABC4D
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London
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
Type 1 Diabetes
Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1.
- Trial name
- FAST 1 (NCT05508061)
- Testing
- Insulin Lispro Cartridge [Lyumjev], Insulin Lispro Cartridge
- Where
- 3 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Inreda Diabetic B.V.
Type 1 Diabetes Mellitus
The Artificial Pancreas in Very Young Children With T1D
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme and JDRF.
- Trial name
- KidsAP02 (NCT03784027)
- Testing
- CamAPS FX, Sensor augmented therapy
- Where
- 8 sites in Austria, Germany and 2 more
- Volunteers
- 81 people
- Sponsor
- University of Cambridge
Type 1 Diabetes Mellitus
Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes.
- Trial name
- NCT02516150
- Testing
- Ethanol, Glucagon
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Massachusetts General Hospital
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
Type1 Diabetes
Neural-net Artificial Pancreas (NAP)
This study is intended to assess a Neural-net Artificial Pancreas (NAP) implementation of an established AP controller - the University of Virginia Model Predictive Control Algorithm (UMPC).
- Trial name
- NAP (NCT05876273)
- Testing
- Neural-net Artificial Pancreas, University of Virginia Model Predictive Control
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus, Hypoglycemia
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
This is a randomized crossover trial with 1:1 randomization to the admission sequence of using the Control AP system (rMPC - Naïve Model Predictive Control) vs.
- Trial name
- NCT03859401
- Testing
- EnMPC (Ensemble Model Predictive Control) AP Controller, rMPC (Naïve Model Predictive Control) AP Controller
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Marc Breton
Hypoglycemia
Post Bariatric Closed Loop Glucagon Trial
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
- Trial name
- NCT02966275
- Testing
- Glucagon-only bionic pancreas - glucagon
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Type1 Diabetes Mellitus
A Pilot Test of t:Slim X2 With Control-IQ Technology
A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology
- Trial name
- NCT03368937
- Testing
- Tandem t:slim X2 with Control-IQ Technology
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Virginia
Type 1 Diabetes
Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes
The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed.
- Trial name
- RocketAP (NCT04545567)
- Testing
- RocketAP, USS Virginia
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
- Trial name
- NCT03804983
- Testing
- Hybrid Closed Loop (HCL), Control-IQ with MyTDI
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Virginia
Type 1 Diabetes, Pregnancy
Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into…
- Trial name
- NCT04492566
- Testing
- Automated Insulin Delivery
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sansum Diabetes Research Institute
Diabetes Mellitus
USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood…
- Trial name
- NCT02131766
- Testing
- DiAs, Sensor Augmented Pump Therapy
- Where
- 4 sites in United States, Italy
- Volunteers
- 33 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
A Study of t:Slim X2 With Control-IQ Technology
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
- Trial name
- DCLP5 (NCT03844789)
- Testing
- t:slim X2 with Control-IQ Technology & Dexcom G6 CGM, Control Group
- Where
- 4 sites in United States
- Volunteers
- 101 people
- Sponsor
- University of Virginia
Type 1 Diabetes
The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes…
- Trial name
- NCT04796779
- Testing
- Tandem t:slim X2 with Control-IQ Technology Pro, Standard Care (SC), Tandem t:slim X2 with Control-IQ Technology V1.5
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Marc Breton
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
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