NCT06834568

Tandem Freedom - Feasibility Trial 2

Completed NA Results posted Last updated 6 February 2026

What this trial tests

NA trial testing t:slim X2 insulin pump with Tandem Freedom Algorithm in Diabetes Mellitus, Type 1 in 10 participants. Completed in 7 April 2025.

Timeline

24 March 2025

Primary endpoint
7 April 2025

7 April 2025

Quick facts

Lead sponsor	Tandem Diabetes Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	24 March 2025
Primary completion	7 April 2025
Estimated completion	7 April 2025
Sites	1 location across New Zealand

Drugs / interventions tested

• t:slim X2 insulin pump with Tandem Freedom Algorithm

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Tandem Diabetes Care, Inc.

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With One or More Severe Hypoglycemia Events Primary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

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

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	0

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	0

Number of Participants With One or More Diabetic Ketoacidosis Events Primary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

Number of Participants with One or More Diabetic Ketoacidosis events

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	0

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	0

Percent Time <54 mg/dL Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured percent time \<54 mg/dL

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	0.4	0.2 – 1.1

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	0.0	0.0 – 0.0

Percent Time <70 mg/dL Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured percent time \<70 mg/dL

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	1.8	0.8 – 3.0

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	0.4	0.0 – 0.8

Percent Time in Range 70 - 180 mg/dL Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

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

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	56.3	50.9 – 64.0

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	61.0	58.9 – 73.0

Percent Time in Range > 180 mg/dL Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured percent time in range \> 180 mg/dL

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	41.8	34.0 – 47.5

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	38.2	27.0 – 40.6

Percent Time in Range > 250 mg/dL Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured percent time in range \> 250 mg/dL

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	15.0	12.1 – 18.6

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	5.6	4.9 – 12.6

Percent Time in Range 70 - 140 mg/dL Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

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

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	33.8	30.0 – 46.1

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	42.5	37.9 – 48.6

Mean Glucose (mg/dL) Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured mean glucose (mg/dL)

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	178.3	164.6 – 184.7

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	166.9	153.3 – 168.0

Glucose Coefficient of Variation (%) Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured Coefficient of Variation (%)

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	0.4	0.3 – 0.4

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	0.3	0.3 – 0.4

Glucose Standard Deviation (mg/dL) Secondary · Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)

CGM measured Standard Deviation (mg/dL)

Control-IQ Run-in Period (7 days)

Group	Value	95% CI
Tandem Freedom	67.8	61.0 – 70.2

Tandem Freedom (3 days)

Group	Value	95% CI
Tandem Freedom	51.3	45.5 – 64.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Run-in Period

Serious: 0/10 (0%)

Deaths: 0/10

Tandem Freedom

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (2 terms — click to expand)

Reaction	System	Run-in Period	Tandem Freedom
Superficial burn	Skin and subcutaneous tissue disorders	—	—
Headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT06834568 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fully Closed-Loop Insulin Delivery with High-Carbohydrate and High-Fat Meals Using the Tandem Freedom System.
   Wilkinson TM, de Bock MI, Meier R, Hurd S, et al · · 2025 · cited 1× · PMID 41236930 · DOI 10.1177/19322968251389966