Tandem Freedom - Feasibility Trial 2

NCT06834568 | Completed Results FDA Device

• 1 other identifier: TP-0020402
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 one week run-in, then will use Tandem Freedom in a supervised hotel setting.

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes; T1D; Tandem; t:slim X2; automated insulin delivery

Outcome Measures

Primary Outcomes (2)

• 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)

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

• Number of Participants With One or More Diabetic Ketoacidosis Events

  Number of Participants with One or More Diabetic Ketoacidosis events

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

Secondary Outcomes (9)

• Percent Time <54 mg/dL

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

• Percent Time <70 mg/dL

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

• Percent Time in Range 70 - 180 mg/dL

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

• Percent Time in Range > 180 mg/dL

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

• Percent Time in Range > 250 mg/dL

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

Study Arms (1)

Tandem Freedom

EXPERIMENTAL

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.

Device: t:slim X2 insulin pump with Tandem Freedom Algorithm

Interventions

t:slim X2 insulin pump with Tandem Freedom Algorithm DEVICE

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.

Tandem Freedom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead

Study Sites (1)

University of Otago

Christchurch, 8140, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 41236930 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sr. Clinical Research Associate I
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

(877) 801-6901

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: March 24, 2025
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: May 5, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)