Description
Inclusion Criteria:
- * Diagnosis of type 1 diabetes mellitus for at least 1 year.
- * Participants 18 to 70 years of age.
- * Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks.
- * Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
- * HbA1c ≤ 10.5% at screening.
- * Total daily insulin requirement is less than 139 units/day.
- * Willingness to follow all study procedures, including attending all clinic visits.
- * Willingness to sign informed consent and HIPAA documents.
Exclusion Criteria:
- * Individual 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 reported by the OHSU laboratory).
- * Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- * History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
- * History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
- * Adrenal insufficiency.
- * Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
- * Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- * Seizure disorder.
- * Active foot ulceration.
- * 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 pramlintide.
- * 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).
- * Current use of any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin).
- * Gastroparesis
- * Diets consisting of less than 50 grams of carbohydrates per day.
- * Dietary restrictions or allergies to the study meals
- * Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.
Ages Eligible for Study:
18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No