Feasibility Study of PID Versus MPC and HMS

Type 1 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987206
• Other study ID #: 2013-11 C2T
• Status: Completed
• Phase: Phase 0
• First received: November 12, 2013
• Last updated: July 20, 2016
• Start date: July 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: William Sansum Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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

• 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:

1. Hematocrit < 30% or >55%

2. A1C > 10%

3. Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine> 1.5 mg/dL)

4. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• MPC control algorithm

• PID control algorithm

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (3)

Lead Sponsor	Collaborator
William Sansum Diabetes Center	Juvenile Diabetes Research Foundation, University of California, Santa Barbara

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):113 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24-hour closed loop	Yes
Secondary	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.	24-hour closed loop	Yes