Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Exclusion Criteria

• •More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
• •More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
• •Inpatient psychiatric treatment in the past 6 months
• •For Female: Currently pregnant or planning to become pregnant during the time period of study participation
• •1. A negative pregnancy test will be required for all females of child-bearing potential
• •2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential
• •Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• •Hemophilia or any other bleeding disorder
• •Hemoglobinopathy
• •History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
• •History of allergic reaction to Humalog or Novolog
• •Use of any medications determined by investigator to interfere with study
• •Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
• •Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
• •History of adrenal insufficiency
• •History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
• •History of gastroparesis
• •A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• •Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
• •Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial