A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery

NCT01492062 | Withdrawn DMC

• 3 other identifiers: SU-09222010-6910SPO: 47012eProtocol: 8566
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor and uses that information to tell an insulin infusion pump how much insulin to deliver. The primary purpose of this study is to gain experience with insulin delivery algorithms or programs program (algorithm) provides the best regulation of glucose levels so that there are no severe low blood glucose reactions and blood glucose levels are generally between 70 to 180 mg/dl.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus; artificial pancreas; closed-loop

Outcome Measures

Primary Outcomes (1)

• Test the feasibility of using MMPPC controller for closed loop insulin delivery in a monitored inpatient clinical research environment.

  Safety: 1) No reference glucose values \<50 mg/dl, and no more than 30 minutes with reference glucose values between 50-60 mg/dl per day based on linear interpolation between values 3) No reference glucose value \>250 mg/dl outside of the 3 hours following a meal.

  36 Hour Admission

Secondary Outcomes (1)

• Efficacy

  30 hour admission

Study Arms (1)

closed-loop control

EXPERIMENTAL

Multiple Model Predictive Controller

Device: Multiple Model Predictive Controller

Interventions

Multiple Model Predictive Controller DEVICE

Use of closed loop algorithm in an inpatient environment while closely monitoring blood glucose levels.

Also known as: artificial pancreas

closed-loop control

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Eligibility
• To be eligible for the study, all subjects must meet the following criteria:
• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; Cpeptide level and antibody determinations are not needed.
• Age 21 years to less than 45.0 years
• Subject has used a downloadable insulin pump for at least 3 months
• Subject understands the study protocol and agrees to comply with it
• Informed Consent Form signed
• A Personal Home computer with internet access (must have access to a PC for uploading, not a Mac).

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible for the study:
• The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
• The presence of any of the following diseases:
• Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
• Cystic fibrosis
• Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• Inpatient psychiatric treatment in the past 6 months
• Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
• Pregnancy, breast feeding, or intention of becoming pregnant in the next 2 months.
• Weight less than 26 kg
• Renal failure or peritoneal dialysis
• History of heart disease
• The use of beta-blockers
• History of cerebrovascular disease, or non-hypoglycemic seizures, or intolerance of glucagon treatment.
• History of a hypoglycemic seizure within 6 months of enrollment.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

CTRU located in Blake Wilbur

Stanford, California, 94305, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• Bruce A. Buckingham

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Endocrinology

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: December 14, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 2, 2015

Record last verified: 2015-03

Locations

US (2)