Clinical trials: Artificial Pancreas
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
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
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
Type 1 Diabetes
Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual in the outpatient environment.
- Trial name
- NCT01762059
- Testing
- Bi-homonal Bionic Pancreas, Usual care
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Massachusetts General Hospital
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
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
Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (T1DM), however after a meal sugars are always a concern.
- Trial name
- NCT02328040
- Testing
- Sitagliptin and insulin/novolog via CL
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Albert Einstein College of Medicine
Type 1 Diabetes
The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs.
- Trial name
- NCT01833988
- Testing
- Bi-hormonal Bionic Pancreas, Usual Care
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Massachusetts General Hospital
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
Type 1 Diabetes
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
- Trial name
- NCT04084171
- Testing
- Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
Type 1 Diabetes
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms
Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain…
- Trial name
- PHM2 (NCT02438189)
- Testing
- Predictive Hyperglycemia Minimization Algorithm, Predictive Hypoglycemia Minimization Algorithm
- Where
- 3 sites in United States, Canada
- Volunteers
- 33 people
- Sponsor
- Jaeb Center for Health Research
Type 1 Diabetes
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
- Trial name
- NCT02018627
- Testing
- Xeris glucagon, Lilly glucagon
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Steven J. Russell, MD, PhD
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
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 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 Mellitus
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.
- Trial name
- NCT02558491
- Testing
- Decision Support System, Usual Care
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Daniel Chernavvsky, MD
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
Type 1 Diabetes
Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting
Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic excursions than insulin mono-therapy.
- Trial name
- NCT01755416
- Testing
- Closed loop with sensor and Insulin, Closed loop with sensor, Insulin and Liraglutide
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Albert Einstein College of Medicine
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
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