Clinical trial NCT06428591: Tandem Freedom - Feasibility Trial 1
Official title: Tandem Freedom - Feasibility Trial 1
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: 2024-05-24
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 1 week run-in, then will use Tandem Freedom in a supervised hotel setting for 3 days/nights.

Detailed description: After a 1 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 3 days/nights in a supervised hotel setting. Participants will perform meal and 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.
* 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

Primary outcomes:
measure: Severe Hypoglycemia events
timeFrame: 3 days
measure: Diabetic Ketoacidosis events
timeFrame: 3 days
measure: Unanticipated adverse device effects
timeFrame: 3 days
measure: Other serious device-related adverse events
timeFrame: 3 days
Secondary outcomes:
measure: Percent Time <70 mg/dL, overall
timeFrame: 3 days
measure: Percent Time <70 mg/dL, daytime
timeFrame: 3 days
measure: Percent Time <70 mg/dL, nighttime
timeFrame: 3 days
measure: Percent Time <54 mg/dL, overall
timeFrame: 3 days
measure: Percent Time <54 mg/dL, daytime
timeFrame: 3 days
measure: Percent Time <54 mg/dL, nighttime
timeFrame: 3 days
measure: Percent Time in Range 70 - 180 mg/dL, overall
timeFrame: 3 days
measure: Percent Time in Range 70 - 180 mg/dL, daytime
timeFrame: 3 days
measure: Percent Time in Range 70 - 180 mg/dL, nighttime
timeFrame: 3 days
measure: Percent Time in Range 70 - 140 mg/dL, overall
timeFrame: 3 days
measure: Percent Time in Range 70 - 140 mg/dL, daytime
timeFrame: 3 days
measure: Nighttime Percent between 70-140 mg/dL, nighttime
timeFrame: 3 days
measure: Percent Time >180 mg/dL, overall
timeFrame: 3 days
measure: Percent Time >180 mg/dL, daytime
timeFrame: 3 days
measure: Percent Time >180 mg/dL, nighttime
timeFrame: 3 days
measure: Percent Time >250 mg/dL, overall
timeFrame: 3 days
measure: Daytime Percent time >250 mg/dL, daytime
timeFrame: 3 days
measure: Nighttime Percent time >250 mg/dL, nighttime
timeFrame: 3 days
measure: Mean glucose (mg/dL), overall
timeFrame: 3 days
measure: Mean glucose (mg/dL), daytime
timeFrame: 3 days
measure: Mean glucose (mg/dL), nighttime
timeFrame: 3 days
measure: Glycemic Variability as assessed by Coefficient of Variation (%), overall
timeFrame: 3 days
measure: Glycemic Variability as assessed by Coefficient of Variation (%), daytime
timeFrame: 3 days
measure: Glycemic Variability as assessed by Coefficient of Variation (%), nighttime
timeFrame: 3 days
measure: Glycemic Variability as assessed by Standard Deviation (mg/dL), overall
timeFrame: 3 days
measure: Glycemic Variability as assessed by Standard Deviation (mg/dL), daytime
timeFrame: 3 days
measure: Glycemic Variability as assessed by Standard Deviation (mg/dL), nighttime
timeFrame: 3 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: University of Otago
Study officials:
affiliation: Tandem Diabetes Care
name: Jordan Pinsker, MD
role: STUDY_DIRECTOR
References: