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Type I Diabetes MellitusPhase 2NCT01552603

Artificial Pancreas Control System in an Inpatient Setting

A Phase 2 study of Type I Diabetes Mellitus, run by Legacy Health System at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Type I Diabetes Mellitus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesUnited States
Study dates
Mar 2012to Sep 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Legacy Good Samaritan Hospital

    Portland, Oregon, 97210

  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in a Supervised Inpatient Setting

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.

Read the detailed description

The objective of the current human study is to verify the components of the Artificial Pancreas Control system during an inpatient study. This master controller software is designed to be used in conjunction with two subcutaneous continuous glucose monitoring systems to regulate blood glucose levels as well as two Omnipod pumps, one for administering insulin and one for administering glucagon. The sensors communicate wirelessly with two sensor receivers which will be interfaced with the APC by wireless USB connection. The insulin and glucagon pumps will be controlled by the APC through a wireless USB connection. The algorithm included in the APC is an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm, which was previously studied as an investigational device. The APD has been studied in vivo (in 28 experiments, each 33 hr in length, with manual adjustment of pumps) and no serious adverse effects were noted. Manual input of the glucose sensor data and insulin/glucagon infusion rates will no longer be necessary. The APC will be tested in vivo during 28 hour experiments in an inpatient setting in preparation for outpatient testing.

Being tested
Artificial Pancreas Control Software
Keywords
glucose sensors, artificial pancreas, Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Pancreas Control SoftwareDevice

    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.

Study groups in NCT01552603
Study groupRoleWhat they receive
Artificial Pancreas ControlExperimentalType 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.
Receives: Device: Artificial Pancreas Control Software

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent of Time in Target Blood Glucose Range

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

    Measured: all 28 hour studies

Secondary outcomes (1)

  1. Mean Deviation From Target Blood Glucose

    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.

    Measured: all 28 hour studies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01552603
Sponsor's protocol ID
2011.11
Status last verified
Apr 2016
First submitted
22 Feb 2012
Last updated
3 Jun 2016
Data monitoring committee
Yes

Publications

  • El Youssef J, Castle JR, Branigan DL, Massoud RG, Breen ME, Jacobs PG, Bequette BW, Ward WK. A controlled study of the effectiveness of an adaptive closed-loop algorithm to minimize corticosteroid-induced stress hyperglycemia in type 1 diabetes. J Diabetes Sci Technol. 2011 Nov 1;5(6):1312-26. doi: 10.1177/193229681100500602.

    PubMed 22226248

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Type I Diabetes Mellitus, run by Legacy Health System at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent of Time in Target Blood Glucose Range (time frame: all 28 hour studies). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01552603, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.

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