Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-03 @ 7:29 AM
Study NCT ID:
NCT02536950
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2015-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2015-07-18', 'studyFirstSubmitQcDate': '2015-08-29', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean glucose', 'timeFrame': 'change over 5 days', 'description': 'Dexcom G4P AP mean glucose'}], 'secondaryOutcomes': [{'measure': '% time <50 mg/dl', 'timeFrame': 'change over 5 days', 'description': 'Fraction of Dexcom G4P AP readings \\<60 mg/dl'}, {'measure': '% time <70 mg/dl', 'timeFrame': 'change over 5 days', 'description': 'Fraction of Dexcom G4P AP readings \\<70 mg/dl'}, {'measure': '% time 70-120 mg/dl', 'timeFrame': 'change over 5 days', 'description': 'Fraction of Dexcom G4P AP readings 70-120 mg/dl'}, {'measure': '% time 70-180 mg/dl', 'timeFrame': 'change over 5 days', 'description': 'Fraction of Dexcom G4P AP readings 70-180 mg/dl'}, {'measure': '% time >180 mg/dl', 'timeFrame': 'change over 5 days', 'description': 'Fraction of Dexcom G4P AP readings \\>180 mg/dl'}, {'measure': '% time >250 mg/dl', 'timeFrame': 'change over 5 days', 'description': 'Fraction of Dexcom G4P AP readings \\>250 mg/dl'}, {'measure': '% time < 60 mg/dl', 'timeFrame': 'Change over 5 days', 'description': 'Fraction of Dexcom G4AP readings \\< 60 mg/dl'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bionic pancreas', 'closed-loop control', 'artificial pancreas'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 diabetes for at least 1 year\n* insulin pump for ≥ 6 months\n* Prescription medication regimen stable for \\> 1 month\n* Subject comprehends written English\n* Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD (Intrauterine Device)\n* Female patients must have a negative urine pregnancy test\n* Informed Consent Form signed by the subject\n* Lives and works within a 60 minute drive-time radius of Stanford University\n* Willing to remain within a 60 minute drive-time radius of Stanford University during all 3 of the 7-day study arms (21 days)\n* Have someone over 18 years of age who lives with them,\n\nExclusion Criteria:\n\n* 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)\n* Subject has a history of diagnosed medical eating disorder\n* Subject has a history of visual impairment which would not allow subject to participate\n* Subject has an active skin condition that would affect sensor placement\n* Subject has adhesive allergies\n* Subjects requiring an intermediate or long-acting insulin (such as NPH, Neutral Protamine Hagedorn, detemir or glargine)\n* Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)\n* 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\n* 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\n* Subject has active Graves' disease\n* Subjects with inadequately treated thyroid disease or celiac disease\n* History of liver disease Renal failure on dialysis\n* Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes\n* Any known history of coronary artery disease\n* Abnormal EKG (electrocardiogram) consistent with coronary artery disease or increased risk of malignant arrhythmia\n* Congestive heart failure (established history of congestive heart failure , lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)\n* History of transient ischemic attack (TIA) or stroke\n* Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants\n* History of hypoglycemic seizures (grand-mal) or coma in the last year\n* History of pheochromocytoma:\n* episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension\n* paroxysms of tachycardia, pallor, or headache\n* personal or family history of MEN 2A (multiple endocrine neoplasia), MEN 2B, neurofibromatosis, or von Hippel-Lindau disease\n* History of adrenal disease or tumor\n* Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 despite treatment\n* Untreated or inadequately treated mental illness\n* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference\n* Unable to completely avoid acetaminophen for duration of study\n* Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n* History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight\n* History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n* Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)\n* Any factors that, in the opinion of the site principal investigator or overall principal investigator, would interfere with the safe completion of the study"}, 'identificationModule': {'nctId': 'NCT02536950', 'briefTitle': 'An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas', 'orgStudyIdInfo': {'id': 'IRB34914'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Blinded Sensor', 'description': 'Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week'}, {'type': 'EXPERIMENTAL', 'label': 'Fixed set point', 'description': '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', 'interventionNames': ['Device: Fixed set point']}, {'type': 'EXPERIMENTAL', 'label': 'Variable Set Point', 'description': 'Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day', 'interventionNames': ['Device: Variable set point']}], 'interventions': [{'name': 'Fixed set point', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Fixed set point']}, {'name': 'Variable set point', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Variable Set Point']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Bruce A Buckingham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford School of Medicine, Pediatric Endocrinology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bruce A. Buckingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics (Endocrinology), MD', 'investigatorFullName': 'Bruce A. Buckingham', 'investigatorAffiliation': 'Stanford University'}}}}