Type 1 Diabetes MellitusEarly Phase 1NCT01472406
Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)
A Early Phase 1 study testing Sansum Closed-Loop Artificial Pancreas, Insulin infusion pump and Continuous Glucose Monitor in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Sansum Closed-Loop Artificial Pancreas, Insulin infusion pump and Continuous Glucose Monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid actin insulin
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 21 to 65 years
- For females, not currently known to be pregnant or nursing
- HbA1c between 5.0% and 10%, as measured with DCA2000 or equivalent device
- Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for insulin pump and CGM wear.
Show all 9Show fewer
- Willing to use the study CGM and study insulin pump during closed-loop.
- Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of CRC visit: acetaminophen, prednisone, and pseudoephedrine.
- An understanding of and willingness to follow the protocol and sign the informed consent
Who cannot join
- Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
- Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Current treatment for a seizure disorder; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
- Cystic fibrosis
- Active infection
Show all 25Show fewer
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
- Presence of a known adrenal disorder
- Active coronary artery disease or heart failure
- Active gastroparesis
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Uncontrolled thyroid disease. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- Abuse of alcohol
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
- Current use of a beta blocker medication
- Laboratory results:
- Hematocrit < 30% or >55%
- A1C > 10%
- Abnormal liver or renal function (Transaminase > 2 times the upper limit of normal, Creatinine> 1.5 mg/dL)
- Labs drawn at screening visit or within one month prior to screening (for other purposes) will suffice for enrollment purposes related to hematocrit
- Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
- Current participation in another investigational trial or has previously participated to this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Artificial Pancreas Device Feasibility Study for Type 1 Diabetes Patients Using Model-predictive Control and Health Monitoring System Algorithms With an Approved Subcutaneous Insulin Delivery Pump and Subcutaneous Continuous Glucose Monitor
This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20 adults subjects aged 21 to 65 years old.
Read the detailed description
The study consists of an evaluation of the Artificial Pancreas device during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA). The 24-hour period includes:
- 2 unannounced meals (evening dinner and breakfast);
- 1 period of 30 minutes of exercise at 50% of the predicted heart rate reserve (HRR) preceded with a snack and followed by a snack 3 hours later (on Day 2);
- complete night from 12:00 am to 7:00 am; The subject will arrive at approximately 4:00 pm to the CRC (clinical research center), the closed-loop will be initiated at approximately 4:30 pm that same day and continued until 4:30 pm the next day. A physician will be monitoring the patient with the artificial Pancreas (AP) device at all time.
The proposed study will evaluate the performance of the AP device in predicting the fall and rise of glucose values and in regulating insulin delivery to mitigate extreme blood glucose variations during the following challenges:
- following unannounced meals,
- during a nocturnal period, and
- during a period of active exercise.
The goal is to demonstrate that the AP device is able to maintain the subject blood glucose within a safe range at all times. One of the objectives of the study will be to measure the percent of time spent in the following zones:
- [80-140] mg/dL at all times unless described otherwise
- [80-140] mg/dL during the nocturnal period
- [70-180] mg/dL postprandial, for 5 hours following the unannounced meals
- [70-150] mg/dL during and for 3 hours following exercise It is anticipated that following the planned challenges, glucose value might increase temporarily beyond those ranges. These excursions will be reviewed and analyzed (value and duration) and the study will determine how the AP device mitigates those excursions and maintains glucose levels within a safe and acceptable range. The clinical study will also review any event that occur during the course of the 24-hour closed-loop: hypoglycemic events, hyperglycemic events, outside intervention, other Adverse Event, Serious Adverse Events, Unanticipated Adverse Device Effect, and device complaints for the commercial devices used. The safety of the patient will remain the primary goal. The goal of the AP device is to operate without outside intervention even when challenged by meals or exercise unless the outside intervention is requested by the Health Monitoring System (HMS).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Sansum Closed-Loop Artificial Pancreas, Insulin infusion pump, Continuous Glucose Monitor, zone-Model Predictive Control algorithm, Safety Health Monitoring System
- Keywords
- type 1 diabetes mellitus, closed-loop artificial pancreas
- 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.
Sansum Closed-Loop Artificial PancreasDevice
Also called Sansum AP
The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.
Insulin infusion pumpDevice
The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.
Continuous Glucose MonitorDevice
Also called CGM
The CGM, which is an approved device (P050012), measures interstitial glucose.
zone-Model Predictive Control algorithmDevice
Also called zone-MPC
The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.
Safety Health Monitoring SystemDevice
Also called HMS
The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop session | Experimental | The study consists of an evaluation of the Sansum Closed-loop Artificial Pancreas Device, insulin infusion pump, Continuous Glucose Monitor, zone-Model Predictive Control algorithm, and a Safety Health Monitoring System. during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA). Receives: Device: Sansum Closed-Loop Artificial Pancreas; Device: Insulin infusion pump; Device: Continuous Glucose Monitor; Device: zone-Model Predictive Control algorithm; Device: Safety Health Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of time within zone [80-140] mg/dL except 5 hours post-prandial and during exercise and 3 hours post-exercise
Measures ability of AP device to maintain glucose level within a safe zone and to return to save zone following unannounced meals and exercises.
Measured: 24 hours
Secondary outcomes (4)
% of time within zone [80-140] mg/dL during night between 12:00 am and 7:00 am
Measures ability of AP device to maintain glucose level with a safe zone during the night and prevent hypoglycemia
Measured: 24 hours
% of time within zone [70-180] mg/dL 5 hours after unannounced evening meal, and breakfast
Measures ability of AP device to react to small meal and to prevent glucose level from dangerous excursions.
Measured: 24 hours
% of time within zone [70-150] mg/dL during the 30 min exercise
Measures ability of AP device to maintain safe glucose level during 30 minutes of non-strenuous exercise
Measured: 24 hours
% of time within zone [70-150] mg/dL during the 3 hours following exercise
Measures ability of AP device to address exercise and to prevent glucose level from dangerous excursions
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Santa Barbara
- Responsible party
- Sponsor
- Investigators
- Howard Zisser, MD, Principal investigator, Sansum Diabetes Research InstituteFrancis J Doyle, PhD, Study director, University of California, Santa Barbara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472406
- Sponsor's protocol ID
- DK085628
- Status last verified
- Sep 2021
- First submitted
- 27 Oct 2011
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harvey RA, Dassau E, Bevier WC, Seborg DE, Jovanovic L, Doyle FJ 3rd, Zisser HC. Clinical evaluation of an automated artificial pancreas using zone-model predictive control and health monitoring system. Diabetes Technol Ther. 2014 Jun;16(6):348-57. doi: 10.1089/dia.2013.0231. Epub 2014 Jan 28.
PubMed 24471561
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Pancreas Device Feasibility Study for Type 1 Diabetes Patients Using Model-predictive Control and Health Monitoring System Algorithms With an Approved Subcutaneous Insulin Delivery Pump and Subcutaneous Continuous Glucose Monitor
- ClinicalTrials.gov ID
- NCT01472406
- Acronym / sponsor ID
- DK085628
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, closed-loop artificial pancreas
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- University of California, Santa Barbara
- Study start
- Nov 2011 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20 adults subjects aged 21 to 65 years old.
Detailed description
The study consists of an evaluation of the Artificial Pancreas device during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA). The 24-hour period includes:
- 2 unannounced meals (evening dinner and breakfast);
- 1 period of 30 minutes of exercise at 50% of the predicted heart rate reserve (HRR) preceded with a snack and followed by a snack 3 hours later (on Day 2);
- complete night from 12:00 am to 7:00 am; The subject will arrive at approximately 4:00 pm to the CRC (clinical research center), the closed-loop will be initiated at approximately 4:30 pm that same day and continued until 4:30 pm the next day. A physician will be monitoring the patient with the artificial Pancreas (AP) device at all time.
The proposed study will evaluate the performance of the AP device in predicting the fall and rise of glucose values and in regulating insulin delivery to mitigate extreme blood glucose variations during the following challenges:
- following unannounced meals,
- during a nocturnal period, and
- during a period of active exercise.
The goal is to demonstrate that the AP device is able to maintain the subject blood glucose within a safe range at all times. One of the objectives of the study will be to measure the percent of time spent in the following zones:
- [80-140] mg/dL at all times unless described otherwise
- [80-140] mg/dL during the nocturnal period
- [70-180] mg/dL postprandial, for 5 hours following the unannounced meals
- [70-150] mg/dL during and for 3 hours following exercise It is anticipated that following the planned challenges, glucose value might increase temporarily beyond those ranges. These excursions will be reviewed and analyzed (value and duration) and the study will determine how the AP device mitigates those excursions and maintains glucose levels within a safe and acceptable range. The clinical study will also review any event that occur during the course of the 24-hour closed-loop: hypoglycemic events, hyperglycemic events, outside intervention, other Adverse Event, Serious Adverse Events, Unanticipated Adverse Device Effect, and device complaints for the commercial devices used. The safety of the patient will remain the primary goal. The goal of the AP device is to operate without outside intervention even when challenged by meals or exercise unless the outside intervention is requested by the Health Monitoring System (HMS).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-loop session | Experimental | Device: Sansum Closed-Loop Artificial Pancreas, Device: Insulin infusion pump, Device: Continuous Glucose Monitor, Device: zone-Model Predictive Control algorithm, Device: Safety Health Monitoring SystemThe study consists of an evaluation of the Sansum Closed-loop Artificial Pancreas Device, insulin infusion pump, Continuous Glucose Monitor, zone-Model Predictive Control algorithm, and a Safety Health Monitoring System. during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid actin insulin
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 21 to 65 years
- For females, not currently known to be pregnant or nursing
- HbA1c between 5.0% and 10%, as measured with DCA2000 or equivalent device
Key exclusion criteria (25 listed)
- Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
- Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Current treatment for a seizure disorder; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
- Cystic fibrosis
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 |
|---|---|---|
| Sansum Closed-Loop Artificial PancreasAlso: Sansum APThe Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS. | Device | Closed-loop session |
| Insulin infusion pumpThe insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set. | Device | Closed-loop session |
| Continuous Glucose MonitorAlso: CGMThe CGM, which is an approved device (P050012), measures interstitial glucose. | Device | Closed-loop session |
| zone-Model Predictive Control algorithmAlso: zone-MPCThe zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump. | Device | Closed-loop session |
| Safety Health Monitoring SystemAlso: HMSThe HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL. | Device | Closed-loop session |
Primary outcome
% of time within zone [80-140] mg/dL except 5 hours post-prandial and during exercise and 3 hours post-exercise
Time frame: 24 hours
Measures ability of AP device to maintain glucose level within a safe zone and to return to save zone following unannounced meals and exercises.
4 secondary outcomes
% of time within zone [80-140] mg/dL during night between 12:00 am and 7:00 am
Time frame: 24 hours
% of time within zone [70-180] mg/dL 5 hours after unannounced evening meal, and breakfast
Time frame: 24 hours
% of time within zone [70-150] mg/dL during the 30 min exercise
Time frame: 24 hours
% of time within zone [70-150] mg/dL during the 3 hours following exercise
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 24471561Harvey RA, Dassau E, Bevier WC, Seborg DE, Jovanovic L, Doyle FJ 3rd, Zisser HC. Clinical evaluation of an automated artificial pancreas using zone-model predictive control and health monitoring system. Diabetes Technol Ther. 2014 Jun;16(6):348-57. doi: 10.1089/dia.2013.0231. Epub 2014 Jan 28.
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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.
Howard Zisser, MD principal investigator
Sansum Diabetes Research Institute
Francis J Doyle, PhD study director
University of California, Santa Barbara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sansum Closed-Loop Artificial Pancreas, Insulin infusion pump and Continuous Glucose Monitor in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute 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 9 inclusion and 25 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 14 Sep 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% of time within zone [80-140] mg/dL except 5 hours post-prandial and during exercise and 3 hours post-exercise (time frame: 24 hours). 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 NCT01472406, 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 14 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.