Outpatient Pramlintide Study

Korábbi kezelés

• History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
• History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• 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).
• Current administration of oral or parenteral corticosteroids.

Más betegség

• 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.
• Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• Adrenal insufficiency.
• Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
• Seizure disorder.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Allergy to Aspart insulin.
• Allergy or intolerance of pramlintide.
• 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).
• Gastroparesis or history of chronic nausea and/or frequent emesis.
• Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol

Laborértékek

• Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the site laboratory).
• Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
• Current use of beta blockers or non-dihydropyridine calcium channel blockers.
• Current use of any medication that may lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin, empaglifozin etc) including the use of GLP1RA medications for weight loss (ex. Wegovy or Zepbound).

Egyéb

• 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.
• Participants will complete a hypoglycemia awareness questionnaire included in Appendix A. Participants will be excluded for four or more R responses.
• Active foot ulceration.
• Low carbohydrate diet at the time of screening defined as less than 50 grams of carbohydrate per day.

• 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.
• Uses a carbohydrate ratio, at least occasionally, to dose meal-time insulin
• HbA1c ≤ 10.5% at screening.
• Total daily insulin requirement is less than 139 units/day.
• Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system.
• Current use of a smartphone so can be contacted by study staff off-campus
• Willingness to follow all study procedures, including attending all clinic visits.
• Willingness to sign informed consent and HIPAA documents.