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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06428591




Registration number
NCT06428591
Ethics application status
Date submitted
20/05/2024
Date registered
24/05/2024
Date last updated
14/06/2024

Titles & IDs
Public title
Tandem Freedom - Feasibility Trial 1
Scientific title
Tandem Freedom - Feasibility Trial 1
Secondary ID [1] 0 0
U1111-1307-6267
Secondary ID [2] 0 0
TP-0017517
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - t:slim X2 insulin pump with Tandem Freedom Algorithm

Experimental: Tandem Freedom - After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system for 3 days/nights.


Treatment: Devices: t:slim X2 insulin pump with Tandem Freedom Algorithm
Participants will use the Tandem Freedom system for 3 day/nights in a supervised hotel setting, performing meal and exercise challenges.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severe Hypoglycemia events
Timepoint [1] 0 0
3 days
Primary outcome [2] 0 0
Diabetic Ketoacidosis events
Timepoint [2] 0 0
3 days
Primary outcome [3] 0 0
Unanticipated adverse device effects
Timepoint [3] 0 0
3 days
Primary outcome [4] 0 0
Other serious device-related adverse events
Timepoint [4] 0 0
3 days
Secondary outcome [1] 0 0
Percent Time <70 mg/dL, overall
Timepoint [1] 0 0
3 days
Secondary outcome [2] 0 0
Percent Time <70 mg/dL, daytime
Timepoint [2] 0 0
3 days
Secondary outcome [3] 0 0
Percent Time <70 mg/dL, nighttime
Timepoint [3] 0 0
3 days
Secondary outcome [4] 0 0
Percent Time <54 mg/dL, overall
Timepoint [4] 0 0
3 days
Secondary outcome [5] 0 0
Percent Time <54 mg/dL, daytime
Timepoint [5] 0 0
3 days
Secondary outcome [6] 0 0
Percent Time <54 mg/dL, nighttime
Timepoint [6] 0 0
3 days
Secondary outcome [7] 0 0
Percent Time in Range 70 - 180 mg/dL, overall
Timepoint [7] 0 0
3 days
Secondary outcome [8] 0 0
Percent Time in Range 70 - 180 mg/dL, daytime
Timepoint [8] 0 0
3 days
Secondary outcome [9] 0 0
Percent Time in Range 70 - 180 mg/dL, nighttime
Timepoint [9] 0 0
3 days
Secondary outcome [10] 0 0
Percent Time in Range 70 - 140 mg/dL, overall
Timepoint [10] 0 0
3 days
Secondary outcome [11] 0 0
Percent Time in Range 70 - 140 mg/dL, daytime
Timepoint [11] 0 0
3 days
Secondary outcome [12] 0 0
Nighttime Percent between 70-140 mg/dL, nighttime
Timepoint [12] 0 0
3 days
Secondary outcome [13] 0 0
Percent Time >180 mg/dL, overall
Timepoint [13] 0 0
3 days
Secondary outcome [14] 0 0
Percent Time >180 mg/dL, daytime
Timepoint [14] 0 0
3 days
Secondary outcome [15] 0 0
Percent Time >180 mg/dL, nighttime
Timepoint [15] 0 0
3 days
Secondary outcome [16] 0 0
Percent Time >250 mg/dL, overall
Timepoint [16] 0 0
3 days
Secondary outcome [17] 0 0
Daytime Percent time >250 mg/dL, daytime
Timepoint [17] 0 0
3 days
Secondary outcome [18] 0 0
Nighttime Percent time >250 mg/dL, nighttime
Timepoint [18] 0 0
3 days
Secondary outcome [19] 0 0
Mean glucose (mg/dL), overall
Timepoint [19] 0 0
3 days
Secondary outcome [20] 0 0
Mean glucose (mg/dL), daytime
Timepoint [20] 0 0
3 days
Secondary outcome [21] 0 0
Mean glucose (mg/dL), nighttime
Timepoint [21] 0 0
3 days
Secondary outcome [22] 0 0
Glycemic Variability as assessed by Coefficient of Variation (%), overall
Timepoint [22] 0 0
3 days
Secondary outcome [23] 0 0
Glycemic Variability as assessed by Coefficient of Variation (%), daytime
Timepoint [23] 0 0
3 days
Secondary outcome [24] 0 0
Glycemic Variability as assessed by Coefficient of Variation (%), nighttime
Timepoint [24] 0 0
3 days
Secondary outcome [25] 0 0
Glycemic Variability as assessed by Standard Deviation (mg/dL), overall
Timepoint [25] 0 0
3 days
Secondary outcome [26] 0 0
Glycemic Variability as assessed by Standard Deviation (mg/dL), daytime
Timepoint [26] 0 0
3 days
Secondary outcome [27] 0 0
Glycemic Variability as assessed by Standard Deviation (mg/dL), nighttime
Timepoint [27] 0 0
3 days

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/06/2024
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tandem Diabetes Care, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06428591
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jordan Pinsker, MD
Address 0 0
Tandem Diabetes Care
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06428591