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Diabetes Mellitus, Type 1NCT06834568

Tandem Freedom - Feasibility Trial 2

A study testing t:slim X2 insulin pump with Tandem Freedom Algorithm in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
t:slim X2 insulin pump with Tandem Freedom Algorithm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNew Zealand
Study dates
24 Mar 2025to 7 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
  • A negative pregnancy test will be required for all females of child-bearing potential
  • Counseling on appropriate birth control options will be provided to all females of child-bearing potential
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • University of Otago

    Christchurch, 8140

Other trials in New Zealand

About this study

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.

Read the 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.

Being tested
t:slim X2 insulin pump with Tandem Freedom Algorithm
Keywords
type 1 diabetes, T1D, Tandem, t:slim X2, automated insulin delivery
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • t:slim X2 insulin pump with Tandem Freedom AlgorithmDevice

    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.

Study groups in NCT06834568
Study groupRoleWhat they receive
Tandem FreedomExperimentalAfter 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.
Receives: Device: t:slim X2 insulin pump with Tandem Freedom Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With One or More Severe Hypoglycemia Events

    Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment)

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  2. Number of Participants With One or More Diabetic Ketoacidosis Events

    Number of Participants with One or More Diabetic Ketoacidosis events

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

Secondary outcomes (9)

  1. Percent Time <54 mg/dL

    CGM measured percent time <54 mg/dL

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  2. Percent Time <70 mg/dL

    CGM measured percent time <70 mg/dL

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  3. Percent Time in Range 70 - 180 mg/dL

    CGM measured percent time in range 70 - 180 mg/dL

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  4. Percent Time in Range > 180 mg/dL

    CGM measured percent time in range > 180 mg/dL

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  5. Percent Time in Range > 250 mg/dL

    CGM measured percent time in range > 250 mg/dL

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  6. Percent Time in Range 70 - 140 mg/dL

    CGM measured percent time in range 70 - 140 mg/dL

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  7. Median of Mean Glucose (mg/dL)

    Median of each participant's mean glucose values (mg/dL)

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  8. Glucose Coefficient of Variation (%)

    CGM measured Coefficient of Variation (%)

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

  9. Glucose Standard Deviation (mg/dL)

    CGM measured Standard Deviation (mg/dL)

    Measured: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start24 Mar 2025
  3. Primary completion7 Apr 2025
  4. Study completion7 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06834568
Sponsor's protocol ID
TP-0020402
Status last verified
Apr 2026
First submitted
13 Feb 2025
Last updated
5 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Wilkinson TM, de Bock MI, Meier R, Hurd S, Sasson-Katchalski R, Trahan A, Rueda JR, Sherer N, Stephens M, Meyer B, Gantulga D, Rackow S, D'Souza EW, Briggs P, Corbett JP, Ulrich TR, Pinsker JE. Fully Closed-Loop Insulin Delivery with High-Carbohydrate and High-Fat Meals Using the Tandem Freedom System. J Diabetes Sci Technol. 2025 Nov 14:19322968251389966. doi: 10.1177/19322968251389966. Online ahead of print.

    PubMed 41236930

Questions about this trial

What is this clinical trial studying?

A study testing t:slim X2 insulin pump with Tandem Freedom Algorithm in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Severe Hypoglycemia Events (time frame: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834568, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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