Type 1 Diabetes MellitusPhase 2NCT01871870
Artificial Pancreas Control System in an Outpatient Setting
A Phase 2 study of Type 1 Diabetes Mellitus, run by Legacy Health System at 1 site in United States.
Trial summary
The objectives of this outpatient research study are (1) to assess the ability of this automated system to be operated by a subject with limited professional oversight; (2) to assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump controller) will reduce the frequency of hardware… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 60 years of age.
- Current use of an insulin pump.
- Willingness to follow all study procedures and to stay with a companion during the outpatient test of the artificial pancreas.
- Willingness to sign informed consent and HIPAA documents.
- Willingness for the subject and companion to attend a training course on the system including emergency management of extremes of glucose.
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 31Show fewer
- Congestive heart failure, NYHA class III or IV.
- Diagnosis of 2nd or 3rd degree heart block or any non-physiological 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 continuous 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 even if controlled by stable therapeutic regimen.
- Current administration of any beta blocker medication, clonidine, reserpine, or guanethidine
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- 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.
- History of hypoglycemic unawareness.
- C peptide level of ≥0.5 ng/ml
- Any reason the principal investigator deems exclusionary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in an Outpatient (Hotel) Setting.
The objectives of this outpatient research study are (1) to assess the ability of this automated system to be operated by a subject with limited professional oversight; (2) to assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump controller) will reduce the frequency of hardware and data communication lapses seen in the previous system; and (3) to measure the degree of glucose control achievable with this automated system. The system will adjust blood glucose by administering insulin and glucagon. Insulin is a hormone that lowers blood glucose and will be given nearly continuously during this study. Glucagon raises blood glucose and will be automatically administered during hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring glucose. The two sensors will feed glucose data into Motorola smart phone master controller, which will calculate the correct amount of insulin or glucagon to deliver. The system will then send the command to the correct Omnipod through the iDex pod controller.
In this new system, the research subject will be able to monitor the progress of the study by use of the smart phone graphical user interface. The subject will have a companion with him/her during the entire study for safety purposes. Both the subject and companion will complete a training course on how to treat diabetic emergencies and how to operate the system. A study physician and technician will be in the hotel during each study and will be monitoring the study via a cloud-based data communication system. These studies will be carried out in a hotel setting.
Read the detailed description
The objective of the current human study is to verify the components of the Artificial Pancreas Control Software during an outpatient 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 Automated APD has been studied in vivo (in 13 experiments, each 28 hr in length, with automated adjustment of pumps) and no serious adverse effects were noted. The APC will be tested in vivo during 28 hour experiments in an outpatient setting in preparation for home testing.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Artificial Pancreas Control Software
- Medical subject headings
- Diabetes Mellitus, Type 1
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 outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Pancreas Control Software | Experimental | 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. Receives: Device: Artificial Pancreas Control Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of the Automation and Telemetry Components
This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.
Measured: 28 hours
Secondary outcomes (1)
Deviation From Target Blood Glucose
Assessment of how accurately the algorithm controls glycemia in the subjects will be carried out using the mean deviation from the target blood glucose (mg/dL). Deviation is measured as algorithm controlled glucose level minus target glucose level.
Measured: 28 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, W. Kenneth Ward, Legacy Health System
- Investigators
- William K Ward, MD, Principal investigator, Legacy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871870
- Sponsor's protocol ID
- 2013.001
- Status last verified
- May 2015
- First submitted
- 29 May 2013
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in an Outpatient (Hotel) Setting.
- ClinicalTrials.gov ID
- NCT01871870
- Acronym / sponsor ID
- 2013.001
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this outpatient research study are (1) to assess the ability of this automated system to be operated by a subject with limited professional oversight; (2) to assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump controller) will reduce the frequency of hardware and data communication lapses seen in the previous system; and (3) to measure the degree of glucose control achievable with this automated system. The system will adjust blood glucose by administering insulin and glucagon. Insulin is a hormone that lowers blood glucose and will be given nearly continuously during this study. Glucagon raises blood glucose and will be automatically administered during hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring glucose. The two sensors will feed glucose data into Motorola smart phone master controller, which will calculate the correct amount of insulin or glucagon to deliver. The system will then send the command to the correct Omnipod through the iDex pod controller.
In this new system, the research subject will be able to monitor the progress of the study by use of the smart phone graphical user interface. The subject will have a companion with him/her during the entire study for safety purposes. Both the subject and companion will complete a training course on how to treat diabetic emergencies and how to operate the system. A study physician and technician will be in the hotel during each study and will be monitoring the study via a cloud-based data communication system. These studies will be carried out in a hotel setting.
Detailed description
The objective of the current human study is to verify the components of the Artificial Pancreas Control Software during an outpatient 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 Automated APD has been studied in vivo (in 13 experiments, each 28 hr in length, with automated adjustment of pumps) and no serious adverse effects were noted. The APC will be tested in vivo during 28 hour experiments in an outpatient setting in preparation for home testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artificial Pancreas Control Software | Experimental | Device: Artificial Pancreas Control SoftwareType 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 60 years of age.
- Current use of an insulin pump.
- Willingness to follow all study procedures and to stay with a companion during the outpatient test of the artificial pancreas.
- Willingness to sign informed consent and HIPAA documents.
Key exclusion criteria (31 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Pancreas Control SoftwareThis 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 outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone. | Device | Artificial Pancreas Control Software |
Primary outcome
Verification of the Automation and Telemetry Components
Time frame: 28 hours
This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.
1 secondary outcome
Deviation From Target Blood Glucose
Time frame: 28 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Ward, MD principal investigator
Legacy Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type 1 Diabetes Mellitus, run by Legacy Health System at 1 site 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 6 inclusion and 31 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 15 May 2015). 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?
Verification of the Automation and Telemetry Components (time frame: 28 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2015.