New insulin system tested in hotel study – no severe events reported
NCT ID NCT06428591
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small study tested a new insulin delivery system called Tandem Freedom in 10 adults with type 1 diabetes. Participants first used their usual system at home for a week, then switched to Tandem Freedom in a supervised hotel setting. The main goals were to check for severe low blood sugar or diabetic ketoacidosis events. The study was completed and focused on safety and glucose control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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May 2024
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study. * 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. * Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one) 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 Novorapid * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Otago
Christchurch, 8140, New Zealand
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