Clinical trials: Closed-Loop Glucose Control
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
Diabetes Mellitus, Type 1
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.
- Trial name
- NCT02679287
- Testing
- CLC
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- University of Virginia
Diabetes Mellitus, Type 1
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8…
- Trial name
- NCT02750267
- Testing
- Diabetes Assistant (DiAs) with Closed-Loop
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
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
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
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
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
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.
Diabetes Mellitus, Hyperglycemia
Inpatient Closed-loop Glucose Control
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may…
- Trial name
- NCT01819844
- Testing
- Closed-loop blood glucose control
- Where
- United States
- Volunteers
- 12 people
- 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 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
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
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
Type 1 Diabetes Mellitus
Glycemic Control and the Brain in Children With Type 1 Diabetes
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care.
- Trial name
- NCT03428932
- Testing
- Closed Loop (Medtronic 670G), Standard Care
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- Nemours Children's Clinic
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
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
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
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 Mellitus
FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with…
- Trial name
- NCT03977727
- Testing
- Fiasp®, Novolog®, 670G hybrid closed loop continuous subcutaneous insulin infusion system
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Texas Diabetes & Endocrinology, P.A.
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