MMPPC Outpatient Clinical Protocol 2016

Study Overview
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Brief Summary
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This study trials a prototype artificial pancreas system that consists of a Roche insulin pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model probabilistic predictive control) algorithm housed on an android cell phone. The system doses insulin based on CGM sensor glucose levels and the experimental algorithm. The aim of this clinical study is to determine the efficacy of the MMPPC controller in adolescents and adults with type 1 diabetes in a hotel setting.

Detailed Description
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This study trials a prototype artificial pancreas system that consists of a Roche insulin pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model probabilistic predictive control) algorithm housed on an android cell phone. The system doses insulin based on CGM sensor glucose levels and the experimental algorithm. The algorithm runs through a glucose control platform called the DiAs (Diabetes Assistant) The aim of this study is to determine the safety and feasibility of the MMPPC controller in adults and adolescents with type 1 diabetes testing the use of predefined tuning parameters to provide adaptability to patient. We will assess the safety of the system with both unannounced meals, and meals using a meal announcement with a premeal insulin bolus based on the subject's estimated carbohydrate content of the meal

Official Title
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Multiple Model Probabilistic Predictive Control (MMPPC) Outpatient Clinical Protocol

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: MMPPC algorithm artificial pancreas


Participation Criteria
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Eligibility Criteria
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3.1 Eligibility Criteria 1. Clinical diagnosis of type 1 diabetes for at least 12 months 2. Daily insulin therapy for at least 12 months 3. Age between 15.0 to 55.0 years of age 4. Use of an insulin pump for at least 3 months 5. Current use of continuous glucose monitoring with Dexcom sensor 6. Subject comprehends English 7. Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test 8. Total daily insulin requirement ≥ 0.3 units/kg/day 9. A1C between 7.0 and 10% 3.2 Exclusion Criteria Diabetic ketoacidosis in the past 6 months Hypoglycemic seizure or loss of consciousness in the past 6 months Hypoglycemia unawareness as defined by no recognition of hypoglycemia until the glucose is <60 mg/dL and no adrenergic symptoms at glucose of 60 mg/dL (shakiness, palpitations, diaphoresis). Subjects will also be administered the Clark questionnaire for hypoglycemia unawareness. If they have a score ≥ 4, they are excluded from the study Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine) Subjects using other anti-diabetic medications other than insulin (oral or injectable) at the time of enrollment. Any prior use of other anti-diabetic medications must be washed out for at least 8 weeks prior to enrollment. Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol Subject is currently participating in another investigational device or drug study within 30 days or 5-half lives of the drug. Subject has a history of any cardiac or vascular disorder including, but not limited to, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease An EKG will be obtained on subjects who are ≥ 45 years of age, or who have had a 20 year history of diabetes and are ≥ 30 years of age. Subjects will be excluded if they have an abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. Subject has a history of hepatic disease Subject has renal failure on dialysis Systolic blood pressure > 160 mmHg on screening visit Diastolic blood pressure > 90 mmHg on screening visit Subjects with inadequately treated thyroid disease or celiac disease Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol Subject has received inpatient psychiatric treatment in the past 6 months Subject consumes more than an average of 4 standard alcoholic drinks/day in the last 30 days Subject has an active skin condition that would affect sensor placement Subject is unable to avoid acetaminophen for the duration of the study Subject consuming less than 100g of carbohydrates daily

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Use the MMPPC system for 72 hours in a hotel setting
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMPPC arm<br>Subjects in this arm will wear the experimental MMPPC algorithm artificial pancreas for 72 hours in a hotel/house setting. The study period will involve unannounced meals and exercise | Device: MMPPC algorithm artificial pancreas<br>* An artificial pancreas system using the MMPPC algorithm, Roche insulin pump, and Dexcom CGM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean CGM glucose value | Average CGm glucose value during the experimental trial | 72 hours | 
| CGM percent time < 60 mg/dl | Percent of time the CGM was reading <60 mg/dl | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM percent time < 50 mg/dl | Percent of time the CGM was reading <50 mg/dl | 72 hours | 
| CGM percent time < 70 mg/dl | Percent of time the CGM was reading <70 mg/dl | 72 hours | 
| % 70-140 mg/dl | Percent of time CGM glucose levels were between 70-140 mg/dl | 72 hours | 
| % 70-180 mg/dl | Percent of time CGM glucose levels were between 70-180 mg/dl | 72 hours | 
| % CGM >180 mg/dl | Percent of time CGM glucose levels were >180 mg/dl | 72 hours | 
| % CGM >250 mg/dl | Percent of time CGM glucose levels were >250 mg/dl | 72 hours | 
| number of SMBG <70 mg/dl | Number of self monitored blood glucose levels less than 70 mg/dl | 72 hours | 
| number of SMBG <60 mg/dl | Number of self monitored blood glucose levels less than 60 mg/dl | 72 hours | 
| number of SMBG <50 mg/dl | Number of self monitored blood glucose levels less than 50 mg/dl | 72 hours | 
| Grams of carbs for hypoglycemia | Number of carbohydrates consumed for treatment of hypoglycemia | 72 hours | 
| Total daily dose of insulin | Total daily dose of insulin | 72 hours | 
| % time CGM used | Percent of time CGM was used | 72 hours | 
| % time in closed loop | Percent of time in closed loop | 72 hours | 
| % of subjects with mean CGM <169 (eHbA1C < 7.5%) | Percentage of subjects with mean CGM value < 169 for the 72 hour period. This corresponds to an estimated hemoglobin A1c of <7.5%. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial pancreas