Comparing 3 approaches for type 1 diabetes mellitus

Exclusion

• −Diagnosis or history indicative of monogenic, Type 2 or post-pancreatectomy diabetes
• −History of \>1 episode of severe (level 3) hypoglycemia in the prior 6 months
• −Significant cardiovascular history defined as:
• −History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
• −Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
• −Uncontrolled hypertension defined as SBP \> 160 mmHg and/or DBP \> 100 mmHg
• −Symptomatic postural hypotension
• −Use of systemic corticosteroids (except physiologic replacement doses for adrenal insufficiency) or other medications that would influence insulin sensitivity
• −Use of non-insulin antihyperglycemic agents within prior 30 days.
• −History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder including previous solid organ or cell transplant that would impact patient safety or data interpretation.
• −History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (any history of treated cervical intraepithelial neoplasia is allowed)
• −Known recreational substance use or psychiatric illness that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may impact the safety of the subject or objectives with scheduled visits
• −A history of alcohol or drug abuse or drug addiction in the previous 12 months
• −A positive pregnancy blood test for women of childbearing age or breast-feeding women 12 Are unwilling to use an "effective" method of contraception during the course of the study. Sexually active male patients, who could have children, are required to use a condom or abstained from intercourse, and refrain from sperm donation for the purposes of conception. Females have to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using a medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence).