Phase
Condition
Diabetes Mellitus, Type 1
Treatment
t:slim X2 insulin pump with Tandem Freedom Algorithm
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years old
Diagnosis of type 1 diabetes for at least 1 year
Current Control-IQ user, having been prescribed Control-IQ for at least 3 months
HbA1c ≤10%, recorded in the last 3 months
Investigator has confidence that the participant can successfully operate all studydevices and is capable of adhering to the protocol, including performing the weekendhotel observed setting portion of the study.
Willing to use only aspart (novorapid) or lispro (humalog) insulin with the studypump, with no use of long-acting basal insulin injections, or inhaled insulin withthe study pump.
Have current glucagon product to treat severe hypoglycemia (injectable or nasal) athome (site will provide prescription if they do not have one)
Exclusion
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 periodof study participation
A negative pregnancy test will be required for all females of child-bearingpotential
Counseling on appropriate birth control options will be provided to all femalesof child-bearing potential
Concurrent use of any non-insulin glucose-lowering agent, other than metformin (forexample, 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 tointerfere with the study
History of allergic reaction to Humalog or Novorapid
Use of any medications determined by investigator to interfere with study
Significant chronic kidney disease (which could impact CGM accuracy ininvestigator's judgment) or hemodialysis
Concurrent use of any medication that could interfere with the study CGM, such ashydroxyurea
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that isnot appropriately treated
History of gastroparesis
A condition, which in the opinion of the investigator or designee, would put theparticipant or study at risk
Participation in another pharmaceutical or device trial at the time of enrollment oranticipated 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 directlyinvolved in conducting the clinical trial (as a study investigator, coordinator,etc.); or having a first-degree relative who is directly involved in conducting theclinical trial
Study Design
Study Description
Connect with a study center
University of Otago
Christchurch, 8140
New ZealandSite Not Available
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