Assessment of a Decision Support Tool in Participants With Type 1 Diabetes

This is an interventional treatment trial for Type 1 Diabetes Read More

Inclusion Criteria:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female subjects 18 to 60 years of age.
• Physically willing and able to perform 30 min of exercise (as determined by the investigator after reviewing the subject's activity level).
• Use of multiple daily insulin injections (MDI) for at least 4 weeks at time of screening visit.
• A1C 7.0-10.0% at the time of screening.
• 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 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 6 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Seizure disorder.
• Active foot ulceration.
• Peripheral arterial disease.
• 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).
• Allergy to aspart insulin.
• 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 (ex. use of liraglutide).
• Vision impairment which in the opinion of the investigator would preclude the use of the smart phone application.
• A positive response to any of the questions from the Physical Activity Readiness Questionnaire with one exception: subject will not be excluded if he/she takes a single blood pressure medication that doesn't impact heart rate and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).