Clinical trials: Type 1 Diabetes Mellitus With Artificial Pancreas Device
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
An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Glycemic Control Using Hybrid-closed Loop vs. Advanced Hybrid Closed-loop in Young Subjects With Type 1 Diabetes
Closed-loop systems are becoming an integral part of diabetes management. These systems were uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while modestly reducing HbA1c levels and improving…
- Trial name
- NCT04269668
- Testing
- Medtronic Minimed 670G 3.0 HCL, Medtronic Minimed 670G 4.0 AHCL
- Where
- 2 sites in Germany, Israel
- Volunteers
- 28 people
- Sponsor
- Rabin Medical Center
Type 1 Diabetes
The Performance of an Artificial Pancreas at Home in People With Type 1 Diabetes
The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available technology represented by Sensor Augmented Pump…
- Trial name
- NCT02040571
- Testing
- Closed Loop, Open Loop
- Where
- Australia
- Volunteers
- 28 people
- Sponsor
- St Vincent's Hospital Melbourne
Diabetes Mellitus, Type 1
Controlled Insulin Delivery: Combining Technology With Treatment
Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose…
- Trial name
- NCT01484457
- Testing
- Closed-loop session
- Where
- 2 sites in United States, Israel
- Volunteers
- 19 people
- Sponsor
- Sansum Diabetes Research Institute
Type 1 Diabetes
Fault Detection, Zone MPC and DiAs System in T1D
This is a randomized crossover study testing the efficacy of the Fault Detection algorithms using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with type 1 diabetes.
- Trial name
- ZoneMPC (NCT02773875)
- Testing
- Artificial pancreas system (Algorithm + CGM + pump)
- Volunteers
- 20 people
- Sponsor
- Rensselaer Polytechnic Institute
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
Diabetes Mellitus, Type 1
Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy.
- Trial name
- GluST1 (NCT02232971)
- Testing
- Glucagon, Isotonic saline solution
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- Hvidovre University Hospital
Type 1 Diabetes
A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes
The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.
- Trial name
- FCL (NCT05199714)
- Testing
- Fiasp, Artificial Pancreas, Pramlintide
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Type 1 Diabetes
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults and Adolescents With Type 1 Diabetes
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's…
- Trial name
- NCT01754337
- Testing
- Closed-loop system
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Institut de Recherches Cliniques de Montreal
Type 1 Diabetes
Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation
In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose…
- Trial name
- NCT02626936
- Testing
- Dual-hormone closed-loop, Insulin, Glucagon
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Institut de Recherches Cliniques de Montreal
Type 1 Diabetes
Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas
To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas
- Trial name
- HEAT1 (NCT06214780)
- Testing
- advanced hybrid closed-loop
- Where
- 9 sites in Spain
- Volunteers
- 193 people
- Sponsor
- Castilla-La Mancha Health Service
Type 1 Diabetes, Type 2 Diabetes
Closed Loop Glucose Control in a Simulated ICU Setting
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Stress Induced Hyperglycemia
- Trial name
- NCT07646067
- Testing
- FUSION closed loop glucose control system
- Volunteers
- 6 people
- Sponsor
- Ideal Medical Technologies
Type 1 Diabetes, Type 1 Diabetes Mellitus
Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is…
- Conditions
- Type 1 Diabetes, Type 1 Diabetes Mellitus, Hyperglycemia, Postprandial
- Trial name
- NCT04163874
- Testing
- Fiasp, Pramlintide Acetate, Artificial Pancreas
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- McGill University
Type 1 Diabetes, Insulin-requiring Type 2 Diabetes Mellitus
Use of Closed Loop Insulin Delivery for Glucose Control in Patients With Insulin Dependent Diabetes Mellitus After Kidney Transplantation
This study will be a prospective, single center, randomized controlled parallel group open-label trial. Participants with insulin requiring diabetes mellitus who have been offered an organ for living or deceased donor kidney…
- Conditions
- Type 1 Diabetes, Insulin-requiring Type 2 Diabetes Mellitus, End Stage Renal Disease (ESRD)
- Trial name
- NCT04189510
- Testing
- Artificial Pancreas, Multiple Daily Injections
- Sponsor
- University of Virginia
Diabetes
Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes
The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy…
- Trial name
- APATDIAGNOSIS (NCT06283797)
- Testing
- OmniPod 5, Dexcom G6, PAID questionnaires
- Where
- 4 sites in France
- Volunteers
- 112 people
- Sponsor
- University Hospital, Montpellier
Type 1 Diabetes, Pregnancy
Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home
This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into…
- Trial name
- NCT04492566
- Testing
- Automated Insulin Delivery
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sansum Diabetes Research Institute
Type 1 Diabetes Mellitus, Pregnancy in Diabetics
Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy
The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period.
- Trial name
- LOIS-P (NCT03761615)
- Testing
- Dexcom G6 CGM
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Sansum Diabetes Research Institute
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 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
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