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Type 1 Diabetes MellitusEarly Phase 1NCT01987206

Feasibility Study of PID Versus MPC and HMS

A Early Phase 1 study of Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site 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 goal of this proposed study is to explore the feasibility of using a PID (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control) controller algorithm in an artificial pancreas system, all other components and study design being equal. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jul 2014to Aug 2015
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • 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 acting 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 to 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.
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  • 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 the close loop study visit: acetaminophen, prednisone, and pseudoephedrine.
  • An understanding of and willingness to follow the protocol and sign the informed consent.

Who cannot join

  • Exhibit hypoglycemia unawareness.
  • Indications of cardiac arrhythmia.
  • 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.
  • Females who are sexually active and able to conceive that do not use contraception.
  • 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
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  • 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
  • Active infection
  • 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.
  • 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 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
  • 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.
  • Currently on long-term treatment using prednisone. If subject had been on short term treatment of prednisone, defer enrollment until underlying condition and prednisone treatment have resolved.
  • Allergy to study drug, food or other study material.
  • Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality.
  • Exposure to any investigational drug within 30 days.
  • History of malignancy within the 5 years before screening (other than basal cell carcinoma).
  • Currently smoking or discontinued smoking (including cigarettes, cigars, pipes) over the past 6 months.
  • Current participation in another investigational trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

Other trials in United States

About this study

Official title: Feasibility Study of Using a PID (Proportional-Integral-Derivative) Controller Versus an MPC (Model Predictive Control) Controller Algorithm and Health Monitoring System (HMS)

The goal of this proposed study is to explore the feasibility of using a PID (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control) controller algorithm in an artificial pancreas system, all other components and study design being equal.

The study consists of an evaluation of either type of control algorithm as a part of the Artificial Pancreas (AP) device during two periods of 27.5-hour closed-loop control in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA) separated by a minimum of 5 days and a maximum of 2 weeks. The 27.5-hour period includes: 2 announced meals (dinner and breakfast of 65g and 50g CHO respectively) preceded with a dose of rapid-acting insulin equivalent to 100% bolus based on each subject's Insulin to Carbohydrate (I:C) ratio and 1 unannounced meal (lunch of 65g carbohydrates, same meal content as dinner); complete night from 12:00 am to 7:00 am. The goal is to demonstrate that the AP device is able to maintain the subject blood glucose within a safe range at all times.

Being tested
MPC control algorithm, PID control algorithm
Keywords
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.

  • MPC control algorithmDevice

  • PID control algorithmDevice

Study groups in NCT01987206
Study groupRoleWhat they receive
PID algorithm with HMSActive comparatorThe control algorithm, at its core, is a Proportional-Integral-Derivative (PID)controller that incorporates an Internal Model Control (IMC) based tuning rule using an explicit model of human T1DM glucose-insulin dynamics. Parameters of the model are personalized based on a priori easily available subject parameters. This controller divides the control action into three components - the proportional distance between the current measurement and the target setpoint, the accumulated integral error as expressed by the area between the current state curve and the target set point over time, and the derivative rate of change of the current measurement. The Health Monitoring System algorithm uses the same glucose monitoring (CGM) data as the PID control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device.
Receives: Device: PID control algorithm
MPC algorithm with HMSExperimentalThe first control strategy is a flavor of Model Predictive Control (MPC) algorithm. MPC employs an explicit model of the process to be controlled when optimizing the input. Specifically, MPC controllers for glycemia control use a model of a human's T1DM insulin-glucose dynamics to predict the evolution of the blood glucose values over a so-called prediction horizon of controller steps, and optimize a predicted insulin input trajectory in order to optimize a specified cost objective that penalizes unsafe glycemic values, and also insulin usage. The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device.
Receives: Device: MPC control algorithm

What is being measured

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

  1. time spent in safe blood glucose range

    The percentage of time spent in safe blood glucose range of [80-140] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are [70-180] mg/dl in the 5 hours after meals.

    Measured: 24-hour closed loop

Secondary outcomes (1)

  1. glucose level extremes and need for outside intervention

    The secondary endpoint measures glucose extremes and the need for outside intervention to prevent hypoglycemia or hyperglycemia. Interventions would be insulin injections or oral carbohydrates given to the subject by the physician. No need for physician intervention will be considered a successful outcome.

    Measured: 24-hour closed loop

Timeline

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

  1. First posted19 Nov 2013 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

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
Early Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987206
Sponsor's protocol ID
2013-11 C2T
Status last verified
Jul 2016
First submitted
12 Nov 2013
Last updated
22 Jul 2016
Results posted
No

Publications

  • Pinsker JE, Lee JB, Dassau E, Seborg DE, Bradley PK, Gondhalekar R, Bevier WC, Huyett L, Zisser HC, Doyle FJ 3rd. Randomized Crossover Comparison of Personalized MPC and PID Control Algorithms for the Artificial Pancreas. Diabetes Care. 2016 Jul;39(7):1135-42. doi: 10.2337/dc15-2344. Epub 2016 Jun 11.

    PubMed 27289127

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study of 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 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 22 Jul 2016. 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?

time spent in safe blood glucose range (time frame: 24-hour closed loop). 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 NCT01987206, 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 22 Jul 2016.

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