Clinical trials: Closed Loop
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
Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D)…
- Trial name
- NCT04878120
- Testing
- Standard HCL System, HCL System with Smart Bolus Calculator
- Where
- United States
- Volunteers
- 25 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 Diabetes
Medtronic Treat to Range (TTR) Closed-Loop Control
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Metabolic and Nutritional Disorders
- Trial name
- NCT01490151
- Testing
- TTR controller (Medtronic)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Stanford University
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
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
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 Mellitus, Autoimmune Diabetes
Medtronic Minimed Overnight Closed-Loop System
To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study.
- Conditions
- Type 1 Diabetes Mellitus, Autoimmune Diabetes, Juvenile-Onset Diabetes, Diabetes, Mellitus, Type 1
- Trial name
- NCT01881009
- Testing
- Hybrid Closed-loop System, Sensor-augmented pump
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Bruce A. Buckingham
Type 1 Diabetes Mellitus
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
- Trial name
- ePID-03 (NCT00831389)
- Testing
- Closed Loop
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy.
- Trial name
- NCT02463097
- Testing
- Insulin Pump
- Where
- 10 sites in United States, Israel
- Volunteers
- 124 people
- Sponsor
- Medtronic MiniMed, Inc.
Sleep Initiation and Maintenance Disorders, Anxiety
HIRREM Developmental Study
The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of…
- Conditions
- Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder, Hot Flashes
- Trial name
- NCT02709369
- Testing
- HIRREM
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Diabetes Mellitus, Type 1
Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels…
- Trial name
- NCT01890954
- Testing
- Diabetes Assistant (DiAs)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Virginia
Type 1 Diabetes
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy.
- Trial name
- NCT02660827
- Testing
- Insulin Pump
- Where
- 11 sites in United States, Israel
- Volunteers
- 151 people
- Sponsor
- Medtronic MiniMed, Inc.
Social Anxiety
Wiring Adolescents With Social Anxiety Via Behavioral Interventions
This study is a validation study to evaluate the acceptability, feasibility and impact of WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions), a mobile application employing a closed-loop technology in…
- Trial name
- WASABI (NCT03990870)
- Testing
- dCBGT + WASABI, dCBGT Only
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Posit Science Corporation
Type 1 Diabetes
Overnight Closed Loop Study in U.S.
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of…
- Trial name
- OCL (NCT01857973)
- Testing
- Hybrid Closed Loop
- Where
- 6 sites in United States
- Volunteers
- 78 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes
Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin…
- Trial name
- NCT05403502
- Testing
- t:slim X2 insulin pump with Control-IQ technology 1.5
- Where
- 13 sites in United States
- Volunteers
- 183 people
- Sponsor
- Tandem Diabetes Care, Inc.
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
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting.
- Trial name
- NCT02748018
- Testing
- 670G and 770G Insulin Pump, Subject's Current Diabetes Therapy
- Where
- 36 sites in United States, Canada and 7 more
- Volunteers
- 959 people
- Sponsor
- Medtronic MiniMed, Inc.
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
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