Exercise Detection Study
Exercise Detection Study
The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during
 exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance
 to pursue physical activity, in order to avoid the discomforting symptoms associated with
 hypoglycemia. The bi-hormonal artificial pancreas, a device used for automatic delivery of
 insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to
 revolutionize the management of this disease. The investigator's group has recently completed
 a study of the bi-hormonal artificial pancreas system during exercise, suggesting reduced
 hypoglycemia around the exercise period. In order to prepare for a future home study, the
 ability to detect, grade, and classify physical activity so as to appropriately adjust system
 parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting.

 This study is designed to collect 3-axis accelerometry data and heart rate data during a
 variety of different home activities, as well as during formal exercise in both healthy
 subjects and subjects with type 1 diabetes. Additionally, the investigators will observe the
 change in glucose levels before and after exercise in subjects with type 1 diabetes.
The artificial pancreas, a device used for automatic delivery of insulin and glucagon
 subcutaneously to subjects with type 1 diabetes, is paving the way to revolutionize the
 management of this disease. Already, the benefit of improved glycemic control compared to
 current open-loop pump therapy has been demonstrated in several trials. The investigator's
 group has shown that artificial pancreas algorithm dual hormone system effectively manages
 blood glucose in a clinic setting and the investigators have specifically shown great
 progress using glucagon to reduce hypoglycemic episodes outside of exercise. The
 investigators most recent inpatient study, as yet unpublished, shows that adjusting insulin
 and glucagon delivery during closed loop treatment, after announcing exercise, effectively
 reduces mean time below a glucose level of 70 mg/dl when compared to closed loop control
 without adjustments. The investigators utilized initial open-loop data from this study to
 help devise dosing changes for the artificial pancreas algorithm.

 In order to prepare for a future home study, the ability to detect, grade, and classify
 physical activity so as to appropriately adjust system parameters is vital in helping to
 prevent exercise induced hypoglycemia in the home setting. Currently, our closed-loop system
 transmits heart rate and accelerometry outputs from a Zephyrlife BioPatch monitoring device
 to a Nexus 5 smart phone master controller via Bluetooth. The algorithm then converts the
 heart rate and accelerometry data into modified estimated energy expenditure - accounting for
 age, weight, height, sex, resting and sitting heart rates - to determine if exercise is
 present. However, further data collection is needed to hone the specificity and sensitivity
 of the detection algorithm to account for a wide variety of subject characteristics and
 activities.

 This study is designed to collect 3-axis accelerometry data and heart rate data during a
 variety of different home activities, as well as during formal exercise, which included
 aerobic exercise (on a calibrated treadmill) and resistance exercise (straight-leg raises or
 equivalent) in healthy subjects as well as subjects with type 1 diabetes. Optionally VO2 data
 from a portable VO2 mask will be obtained. The data collected will be used to further enhance
 our algorithm that, in future closed-loop studies, will detect exercise and automatically
 trigger algorithmic adjustments to reduce exercise-related hypoglycemia during and after
 exercise in individuals with type 1 diabetes.
TYPE 1 DIABETIC SUBJECT CRITERIA

 Inclusion criteria:

 1. Male or female subjects 21 to 45 years of age with a diagnosis of T1D for at least 6
 months on an insulin pump.

 2. Physically active on a regular basis, i.e. at least 3 days of scheduled physical
 activity per week and willing to perform approximately 60 minutes of exercise (as
 determined by the investigator after reviewing the subjects activity level).

 3. Willingness to follow all study procedures.

 4. Willingness to sign informed consent and HIPAA documents.

 Exclusion criteria:

 a. Pregnancy or Lactation: i. For women of childbearing potential, there is a requirement
 for a negative urine pregnancy test. b. Any cardiovascular disease, defined as a clinically
 significant EKG abnormality at the time of screening or any history of: stroke, heart
 failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or
 angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia
 judged by the investigator to be exclusionary. c. Renal insufficiency (GFR < 60 ml/min,
 using the MDRD equation as report by the OHSU laboratory). d. Hematocrit of less than or
 equal to 34%. e. History of severe hypoglycemia during the past 12 months prior to
 screening visit or hypoglycemia unawareness as judged by the investigator. f. Adrenal
 insufficiency. g. Any active infection. h. Known or suspected abuse of alcohol, narcotics,
 or illicit drugs (except marijuana use).

 i. Seizure disorder. j. Active foot ulceration. k. Severe peripheral arterial disease
 characterized by ischemic rest pain or severe claudication. l. Major surgical operation
 within 30 days prior to screening. m. Use of an investigational drug within 30 days prior
 to screening. n. Chronic usage of any immunosuppressive medication (such as cyclosporine,
 azathioprine, sirolimus, or tacrolimus). o. Bleeding disorder, treatment with warfarin, or
 platelet count below 50,000. p. Current administration of oral or parenteral
 corticosteroids. q. Any life threatening disease, including malignant neoplasms and medical
 history of malignant neoplasms within the past 5 years prior to screening (except basal and
 squamous cell skin cancer). r. Any concurrent illness, other than diabetes, that is not
 controlled by a stable therapeutic regimen. s. Beta blockers or non-dihydropyridine calcium
 channel blockers. t. A positive response to any of the questions from the Physical Activity
 Readiness Questionnaire, see Appendix A. u. Any chest discomfort with physical activity,
 including pain or pressure, or other types of discomfort. v. Any clinically significant
 disease or disorder which in the opinion of the Investigator may jeopardize the subject's
 safety or compliance with the protocol.

 HEALTHY SUBJECT CRITERIA

 Inclusion Criteria:

 1. Male or female subjects 21 to 45 years of age.

 2. Physically active on a regular basis, i.e. at least 3 days of scheduled physical
 activity per week and willing to perform approximately 60 minutes of exercise (as
 determined by the investigator after reviewing the subjects activity level).

 3. Willingness to follow all study procedures.

 4. Willingness to sign informed consent and HIPAA documents.

 Exclusion criteria:

 1. Pregnancy or Lactation: For women of childbearing potential, there is a requirement
 for a negative urine pregnancy test.

 2. Any history or evidence of renal insufficiency, adrenal insufficiency, liver disease
 or anemia.

 3. A history of cerebrovascular disease or coronary artery disease (or angina) regardless
 of the time since occurrence.

 4. Congestive heart failure, New York Heart Association (NYHA) any class.

 5. Diagnosis of 1st, 2nd or 3rd degree heart block or any arrhythmia judged by the
 investigator to be exclusionary.

 6. Any condition which, in the opinion of the investigator, makes it difficult to engage
 in vigorous physical activity.

 7. Any active infection.

 8. Severe peripheral arterial disease characterized by ischemic rest pain or severe
 claudication.

 9. Active alcohol abuse, substance abuse, or severe mental illness (as judged by the
 principal investigator).

 10. Active malignancy, except basal cell or squamous cell skin cancers.

 11. Major surgical operation within 30 days prior to screening.

 12. Seizure disorder.

 13. Bleeding disorder, or treatment with warfarin.

 14. Use of any chronic medications.

 15. Use of an investigational drug within 30 days prior to screening.

 16. Any reason the principal investigator deems exclusionary.