Other Clinical Trial - Controlled Insulin Delivery: Combining Technology

Status Completed

Clinical Trial Summary

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 concentrations. This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.

Clinical Trial Description

The goal of the JDRF Artificial Pancreas Project is to produce an autonomous artificial pancreas that can safely and effectively regulate glycemia in people with type 1 diabetes mellitus. In our work, this fully automated closed-loop system combines a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin infusion (CSII) pump with a sophisticated control algorithm. This is a proof-of-concept study to demonstrate that the controller could bring the patient back to a relatively normal glucose concentration after an unannounced meal and from mild hyperglycemia. Once the system is initiated, all insulin delivery is calculated automatically. There was no outside intervention either by the subject or medical personnel. An artificial pancreas system that aims at replicating normal beta-cell function by using the subcutaneous-subcutaneous (sc-sc) route needs to address inherent delays in both glucose sensing and insulin delivery. Our strategic approach is that a closed-loop system should operate safely without any knowledge of meals or other disturbances. We have developed the Artificial Pancreas System (APS©) and used it to clinically evaluate a control strategy that allows efficient glycemic control without any a priori meal information. The Artificial Pancreas device uses the Artificial Pancreas System (APS©) platform with the OmniPod insulin pump, the DexCom SEVEN PLUS CGM and a multi-parametric model predictive control algorithm (mpMPC) with an insulin-on-board (IOB) safety constraint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01484457
Study type	Interventional
Source	Sansum Diabetes Research Institute
Contact
Status	Completed
Phase	Early Phase 1
Start date	July 2008
Completion date	January 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
Terminated	`NCT03605329` - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS	N/A
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting	`NCT06050642` - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.	N/A
Completed	`NCT05107544` - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes	N/A
Active, not recruiting	`NCT04443153` - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes	N/A
Completed	`NCT04521634` - Glycaemic Variability in Acute Stroke
Completed	`NCT04569994` - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes	Phase 1
Completed	`NCT04089462` - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study	N/A
Completed	`NCT03143816` - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study	Phase 4
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A
Completed	`NCT04042207` - Diabeloop for Highly Unstable Type 1 Diabetes	N/A
Not yet recruiting	`NCT06068205` - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting	`NCT05909800` - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.	Phase 2
Active, not recruiting	`NCT04974528` - Afrezza® INHALE-1 Study in Pediatrics	Phase 3
Completed	`NCT04530292` - Home Intervention and Social Precariousness in Childhood Diabetes	N/A
Completed	`NCT05428943` - OPT101 in Type 1 Diabetes Patients	Phase 1
Recruiting	`NCT03988764` - Monogenic Diabetes Misdiagnosed as Type 1
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Controlled Insulin Delivery: Combining Technology With Treatment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms