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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Artificial Pancreas Control System in an Inpatient Setting

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 2
Enrollment
14 participants (actual)
Sponsor
Legacy Health System · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2012
Primary completion
Aug 2013
Completion
Sept 2013
First posted
13 Mar 2012 (estimated)
Last update posted
3 Jun 2016 (estimated)
Conditions
Type I Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2

    Artificial Pancreas Control System in an Inpatient Setting

    NCT01552603

    Mar 2012 to Sept 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to verify an automated system of blood glucose control in Type I Diabetics. The automated system consists of the investigational Artificial Pancreas Control software (APC), two blood glucose sensors, and two hormone pumps, one for delivering insulin to lower blood sugar, and the second for delivering glucagon to raise blood sugar. The blood glucose sensors relays information to the Artificial Pancreas software, which uses the Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon infusion by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm has been verified, but required manual input into the computer and hormone pumps. This study differs in that it uses a fully automated system under the control of the Artificial Pancreas Control software. The importance of this change is that it is the next step to enable outpatient use of automated, closed loop blood glucose control.

Interventions

  • Artificial Pancreas Control SoftwareDevice

Arms1

  • Experimental

    Artificial Pancreas Control

    Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Percent of Time in Target Blood Glucose Range

    Time frame · all 28 hour studies

    Registry description

    Mean percent of time venous blood glucose was sampled between 70-180 mg/dl

Secondary outcomes(1)
  1. Mean Deviation From Target Blood Glucose

    Time frame · all 28 hour studies

    Registry description

    Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· all 28 hour studies

Mean Percent of Time in Target Blood Glucose Range

GroupValue (percentage of time)Spread
Artificial Pancreas Control62.47.0
Secondary and other outcome results(1)
Secondary outcomeMean· all 28 hour studies

Mean Deviation From Target Blood Glucose

GroupValue (mg/dl)Spread
Artificial Pancreas Control59.951.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Artificial Pancreas ControlType 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose. Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm.–0 / 141 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus for at least 1 year. * Male or female subjects 21 to 65 years of age. * Current use of an insulin pump. * Willingness to follow all study procedures, including attending all clinic visits. * Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: * Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. * Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). * Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2. * Adrenal insufficiency * Hematocrit of less than or equal to 34%. * A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence. * Congestive heart failure, NYHA class III or IV. * Diagnosis of 2nd or 3rd degree heart block or any arrhythmia judged by the investigator to be exclusionary. * Any active infection. * Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device. * Physical impairment impeding the ability to use a glucose meter or glucose monitoring device. * Active foot ulceration. * Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication. * Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator). * Active malignancy, except basal cell or squamous cell skin cancers. * Major surgical operation within 30 days prior to screening. * Seizure disorder. * Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). * Current administration of oral or parenteral corticosteroids. * Use of an investigational drug within 30 days prior to screening. * Bleeding disorder, treatment with warfarin, or platelet count below 50,000. * Allergy to aspart insulin. * Allergy to glucagon. * Past history of pheochromocytoma or a family history of MEN 2, neurofibromatosis, or von Hippel-Lindau disease. * Insulin resistance requiring more than 200 units per day. * Need for uninterrupted treatment of acetaminophen. * Intolerance of mild hypoglycemia (glucose 60-70 mg/dl). * History of hypoglycemic unawareness. * Insulin antibody level of ≥ 100 µUnits/ml. * C peptide level of ≥0.5 ng/ml. * Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. * Any reason the principal investigator deems exclusionary

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