Tandem Freedom Feasibility Trial: evaluating the Tandem Freedom system compared to a Control-IQ technology run-in phase in adults with type 1 diabetes
- Conditions
- Type 1 diabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12624000559516
- Lead Sponsor
- niversity of Otago, Christchurch.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
1. Age >=18 years old.
2. Diagnosis of type 1 diabetes for at least 1 year.
3. Current Control-IQ user for at least 3 months.
4. HbA1c<=10%, recorded in the last 3 months
5. Can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
6. Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
1. More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months.
2. More than 1 episode of severe hypoglycaemia (needing assistance) in the past 6 months.
3. Inpatient psychiatric treatment in the past 6 months.
4. For female: Currently pregnant or planning to become pregnant during the time period of study participation.
5. 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).
6. Hemophilia or any other bleeding disorder.
7. Hemoglobinopathy.
8.History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
9.History of allergic reaction to Humalog or Novorapid
10.Use of any medications determined by investigator to interfere with study
11.Significant chronic kidney disease (which could impact continuous glucose monitoring (CGM) accuracy in investigator’s judgment) or hemodialysis
12.Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
13.History of adrenal insufficiency
14.History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
15.History of gastroparesis
16.A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
17.Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
18.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method