Clinical trials: Closed-Loop Glucose Control
Type 1 Diabetes Mellitus
Outpatient Control-to-Range: System and Monitoring Testing
A single arm, single treatment study is proposed to assess the feasibility of the AP Platform (cell phone + Control to Range system) outside of a hospital based clinical research center.
- Trial name
- NCT01578980
- Testing
- Outpatient Control-to-Range
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting.
- Trial name
- NCT01945060
- Testing
- heart rate Control to Range System (hrCTR) using DiAs Platform, DiAs Control-to-Range System not informed for heart rate
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Marc Breton
Diabetes Mellitus, Type 1
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)…
- Trial name
- NCT01714505
- Testing
- Diabetes Assistant (DiAs)
- Where
- 2 sites in United States
- Volunteers
- 20 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
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, 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
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
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness…
- Trial name
- NCT02302963
- Testing
- AP System (DiAs or inControl) with USS Virginia
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- University of Virginia
Type 1 Diabetes
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function.
- Trial name
- NCT00891995
- Testing
- Closed loop, Home glucose monitoring, Insulin pump
- Where
- 5 sites in United States
- Volunteers
- 71 people
- Sponsor
- Jaeb Center for Health Research
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
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
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
Physiologic Response to Glucagon at Varying Insulin Levels
The purpose of this research study is to test how different levels of insulin block the effect of glucagon. Insulin is a hormone that lowers blood glucose. Glucagon raises blood glucose.
- Trial name
- NCT01483651
- Testing
- Glucagon, Insulin
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Legacy Health System
Type 1 Diabetes
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
The investigators are doing this research study to compare the pharmacokinetics (PK) (rate of absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine (Apidra) within individual subjects.
- Trial name
- NCT01684943
- Testing
- Multiplex pharmacokinetic profiling, Continuous insulin monitoring
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Massachusetts General Hospital
Type 1 Diabetes
Two Way Crossover Closed Loop MPC vs Control IQ
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
- NCT05799781
- Testing
- MPC closed-loop system, t:slim X2 pump with Dexcom G6 CGM and Control IQ
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Oregon Health and Science University