Clinical trial NCT06834568: Tandem Freedom - Feasibility Trial 2
Official title: Tandem Freedom - Feasibility Trial 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes
T1D
Tandem
t:slim X2
automated insulin delivery
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a one week run-in, then will use Tandem Freedom in a supervised hotel setting.

Detailed description: After a one week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 4 nights: 1 day with boluses, and 3 days without boluses, in a supervised hotel setting. Participants will perform exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Severe Hypoglycemia events
timeFrame: 4 days
measure: Diabetic Ketoacidosis events
timeFrame: 4 days
Secondary outcomes:
measure: All device-related adverse events
timeFrame: 4 days
measure: Percent Time <54 mg/dL
timeFrame: 4 days
measure: Percent Time <70 mg/dL
timeFrame: 4 days
measure: Percent Time in Range 70 - 180 mg/dL
timeFrame: 4 days
measure: Percent Time in Range > 180 mg/dL
timeFrame: 4 days
measure: Percent Time in Range > 250 mg/dL
timeFrame: 4 days
measure: Percent Time in Range 70 - 140 mg/dL
timeFrame: 4 days
measure: Mean glucose (mg/dL)
timeFrame: 4 days
measure: Glycemic Variability as assessed by Coefficient of Variation (%)
timeFrame: 4 days
measure: Glycemic Variability as assessed by Standard Deviation (mg/dL)
timeFrame: 4 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: University of Otago
Study officials:
affiliation: Tandem Diabetes Care, Inc.
name: Jordan Pinsker, MD
role: STUDY_DIRECTOR
References: