An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

Study Overview
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Brief Summary
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This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.

Detailed Description
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A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.

Official Title
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An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Fixed set point
* Device: Variable set point


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes for at least 1 year insulin pump for ≥ 6 months Prescription medication regimen stable for > 1 month Subject comprehends written English Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD (Intrauterine Device) Female patients must have a negative urine pregnancy test Informed Consent Form signed by the subject Lives and works within a 60 minute drive-time radius of Stanford University Willing to remain within a 60 minute drive-time radius of Stanford University during all 3 of the 7-day study arms (21 days) Have someone over 18 years of age who lives with them, Exclusion Criteria: Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription) Subject has a history of diagnosed medical eating disorder Subject has a history of visual impairment which would not allow subject to participate Subject has an active skin condition that would affect sensor placement Subject has adhesive allergies Subjects requiring an intermediate or long-acting insulin (such as NPH, Neutral Protamine Hagedorn, detemir or glargine) Subjects requiring other anti-diabetic medications other than insulin (oral or injectable) Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial Subject has active Graves' disease Subjects with inadequately treated thyroid disease or celiac disease History of liver disease Renal failure on dialysis Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes Any known history of coronary artery disease Abnormal EKG (electrocardiogram) consistent with coronary artery disease or increased risk of malignant arrhythmia Congestive heart failure (established history of congestive heart failure , lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea) History of transient ischemic attack (TIA) or stroke Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants History of hypoglycemic seizures (grand-mal) or coma in the last year History of pheochromocytoma: episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension paroxysms of tachycardia, pallor, or headache personal or family history of MEN 2A (multiple endocrine neoplasia), MEN 2B, neurofibromatosis, or von Hippel-Lindau disease History of adrenal disease or tumor Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 despite treatment Untreated or inadequately treated mental illness Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference Unable to completely avoid acetaminophen for duration of study Established history of allergy or severe reaction to adhesive or tape that must be used in the study History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring) Any factors that, in the opinion of the site principal investigator or overall principal investigator, would interfere with the safe completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 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: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Blinded Sensor<br>Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week | |
| Experimental: Fixed set point<br>Subjects will be in a hotel and use a fixed set point for glucose control for two days initialized at 130 mg/dl. The setpoint will be adjusted, if necessary, over the two days in the hotel before they are sent home for 5 days | Device: Fixed set point<br>* Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.<br>|
| Experimental: Variable Set Point<br>Subjects will begin using a variable setpoint which will make adjustments based on their past glucose control over the previous day | Device: Variable set point<br>* Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean glucose | Dexcom G4P AP mean glucose | change over 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % time <50 mg/dl | Fraction of Dexcom G4P AP readings <60 mg/dl | change over 5 days | 
| % time <70 mg/dl | Fraction of Dexcom G4P AP readings <70 mg/dl | change over 5 days | 
| % time 70-120 mg/dl | Fraction of Dexcom G4P AP readings 70-120 mg/dl | change over 5 days | 
| % time 70-180 mg/dl | Fraction of Dexcom G4P AP readings 70-180 mg/dl | change over 5 days | 
| % time >180 mg/dl | Fraction of Dexcom G4P AP readings >180 mg/dl | change over 5 days | 
| % time >250 mg/dl | Fraction of Dexcom G4P AP readings >250 mg/dl | change over 5 days | 
| % time < 60 mg/dl | Fraction of Dexcom G4AP readings < 60 mg/dl | Change over 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bionic pancreas, closed-loop control, artificial pancreas