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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02536950
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Boston University
Massachusetts General Hospital
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Fixed set point Device: Variable set point Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Study Start Date : August 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
No Intervention: Blinded Sensor
Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week
Experimental: 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
Device: 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.

Experimental: Variable Set Point
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
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.




Primary Outcome Measures :
  1. Mean glucose [ Time Frame: change over 5 days ]
    Dexcom G4P AP mean glucose


Secondary Outcome Measures :
  1. % time <50 mg/dl [ Time Frame: change over 5 days ]
    Fraction of Dexcom G4P AP readings <60 mg/dl

  2. % time <70 mg/dl [ Time Frame: change over 5 days ]
    Fraction of Dexcom G4P AP readings <70 mg/dl

  3. % time 70-120 mg/dl [ Time Frame: change over 5 days ]
    Fraction of Dexcom G4P AP readings 70-120 mg/dl

  4. % time 70-180 mg/dl [ Time Frame: change over 5 days ]
    Fraction of Dexcom G4P AP readings 70-180 mg/dl

  5. % time >180 mg/dl [ Time Frame: change over 5 days ]
    Fraction of Dexcom G4P AP readings >180 mg/dl

  6. % time >250 mg/dl [ Time Frame: change over 5 days ]
    Fraction of Dexcom G4P AP readings >250 mg/dl

  7. % time < 60 mg/dl [ Time Frame: Change over 5 days ]
    Fraction of Dexcom G4AP readings < 60 mg/dl



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536950


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Bruce A. Buckingham
Boston University
Massachusetts General Hospital
Investigators
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Principal Investigator: Bruce A Buckingham, MD Stanford School of Medicine, Pediatric Endocrinology

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Responsible Party: Bruce A. Buckingham, Professor of Pediatrics (Endocrinology), MD, Stanford University
ClinicalTrials.gov Identifier: NCT02536950     History of Changes
Other Study ID Numbers: IRB34914
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bruce A. Buckingham, Stanford University:
bionic pancreas
closed-loop control
artificial pancreas

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents