Three-way, Cross-over Closed-loop Exercise Study
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes, closed-loop, bi-hormonal, exercise
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 45 years of age.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Willingness to follow all study procedures, including attending all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
Exclusion Criteria:
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- 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.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
- Hematocrit of less than or equal to 34%.
- History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
- Adrenal insufficiency.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Seizure disorder.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Major surgical operation within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Allergy to aspart insulin.
- Allergy to glucagon.
- Insulin resistance requiring more than 200 units per day.
- Need for uninterrupted treatment of acetaminophen.
- Current administration of oral or parenteral corticosteroids.
- 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).
- C peptide level of ≥0.5 ng/ml
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- Beta blockers or non-dihydropyridine calcium channel blockers.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Standard Insulin Pump Therapy
Closed-loop without adjustment
Closed-loop with adjustment
Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.
Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.