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

NCT ID: NCT02536950

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-07-31

Brief Summary

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

Detailed Description

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Blinded Sensor

Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fixed set point

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

Group Type: EXPERIMENTAL

Fixed set point

Intervention Type: DEVICE

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.

Variable Set Point

Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day

Group Type: EXPERIMENTAL

Variable set point

Intervention Type: DEVICE

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.

Interventions

Fixed set point

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.

Intervention Type: DEVICE

Variable set point

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Bruce A. Buckingham

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Buckingham

Professor of Pediatrics (Endocrinology), MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bruce A Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford School of Medicine, Pediatric Endocrinology

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

IRB34914

Identifier Type: -

Identifier Source: org_study_id