Clinical trials: Closed-Loop Glucose Control
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
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
Type1diabetes, Hypoglycemia Unawareness
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month…
- Conditions
- Type1diabetes, Hypoglycemia Unawareness, Nocturnal Hypoglycemia, Hypoglycemia Night
- Trial name
- Aim2 (NCT03215914)
- Testing
- MiniMed 670G system
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- University of Pennsylvania
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
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
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, Obesity
ADJUnct Semaglutide Treatment in Type 1 Diabetes
The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.
- Trial name
- ADJUST-T1D (NCT05537233)
- Testing
- Semaglutide
- Where
- 4 sites in United States
- Volunteers
- 115 people
- Sponsor
- Viral N. Shah
Type 1 Diabetes Mellitus
Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas
Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a…
- Trial name
- NCT03262116
- Testing
- Humalog, Novolog, BC222 insulin lispro
- Where
- United States
- Volunteers
- 20 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
Adaptive Biobehavioral Control (ABC) in a Closed-Loop System
This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential…
- Trial name
- ABC-WIT (NCT05610111)
- Testing
- CLC + BAM, CLC + ABC
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Sue Brown
Type 1 Diabetes
Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)
This study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop.
- Trial name
- NCT00977808
- Testing
- Closed-Loop, Model Predictive Control (MPC), Open-Loop
- Where
- United States
- Volunteers
- 12 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
Closed-loop Glucose Control for Automated Management of Type 1 Diabetes
We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.
- Trial name
- NCT00811317
- Testing
- Closed-loop
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston University Charles River Campus
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 Mellitus
Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery
The purpose of this pilot study is to test the safety and feasibility of using two or three research modules in conjunction with an automated insulin delivery device (AID).
- Trial name
- NCT04784637
- Testing
- Web Simulation Tool (WST), Behavioral Adaptation Module (BAM), Auto Titration Module (ATM)
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled…
- Trial name
- NCT03591354
- Testing
- t:slim X2 with Control-IQ Technology & Dexcom G6 CGM, t:slim X2 with Basal-IQ & Dexcom G6 CGM
- Where
- 7 sites in United States
- Volunteers
- 164 people
- Sponsor
- University of Virginia
Type 1 Diabetes Mellitus
Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp
An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
- Trial name
- NCT03369067
- Testing
- Tandem t:slim X2 with Control-IQ Technology + Dexcom G6, Dexcom CGM G5, Continuous Subcutaneous Insulin Infusion
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- University of Virginia
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