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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06834568




Registration number
NCT06834568
Ethics application status
Date submitted
13/02/2025
Date registered
19/02/2025

Titles & IDs
Public title
Tandem Freedom - Feasibility Trial 2
Scientific title
Tandem Freedom - Feasibility Trial 2
Secondary ID [1] 0 0
TP-0020402
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 one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.

Participants will also perform exercise challenges.


Treatment: Devices: t:slim X2 insulin pump with Tandem Freedom Algorithm
t:slim X2 insulin pump with Tandem Freedom System consists of the Tandem t:slim X2 insulin pump and the Freedom algorithm embedded in the pump. Participants will also use the Dexcom G6 continuous glucose monitoring system.
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
4 days
Primary outcome [2] 0 0
Diabetic Ketoacidosis events
Timepoint [2] 0 0
4 days
Secondary outcome [1] 0 0
All device-related adverse events
Timepoint [1] 0 0
4 days
Secondary outcome [2] 0 0
Percent Time <54 mg/dL
Timepoint [2] 0 0
4 days
Secondary outcome [3] 0 0
Percent Time <70 mg/dL
Timepoint [3] 0 0
4 days
Secondary outcome [4] 0 0
Percent Time in Range 70 - 180 mg/dL
Timepoint [4] 0 0
4 days
Secondary outcome [5] 0 0
Percent Time in Range > 180 mg/dL
Timepoint [5] 0 0
4 days
Secondary outcome [6] 0 0
Percent Time in Range > 250 mg/dL
Timepoint [6] 0 0
4 days
Secondary outcome [7] 0 0
Percent Time in Range 70 - 140 mg/dL
Timepoint [7] 0 0
4 days
Secondary outcome [8] 0 0
Mean glucose (mg/dL)
Timepoint [8] 0 0
4 days
Secondary outcome [9] 0 0
Glycemic Variability as assessed by Coefficient of Variation (%)
Timepoint [9] 0 0
4 days
Secondary outcome [10] 0 0
Glycemic Variability as assessed by Standard Deviation (mg/dL)
Timepoint [10] 0 0
4 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.
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
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
24/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/04/2025
Actual
Sample size
Target
10
Accrual to date
Final
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jordan Pinsker, MD
Address 0 0
Tandem Diabetes Care, Inc.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06834568