Tandem Freedom Feasibility Study 1

NCT06428591 | Completed Results FDA Device

• 2 other identifiers: TP-0017517U1111-1307-6267
• 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 1 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)

• Severe Hypoglycemia Events

  Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

• Diabetic Ketoacidosis Events

  Number of diabetic ketoacidosis events

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

Secondary Outcomes (9)

• Percent Time <54 mg/dL

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

• Percent Time <70 mg/dL

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

• Percent Time in Range 70 - 180 mg/dL

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

• Percent Time in Range 70 - 140 mg/dL

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

• Percent Time >180 mg/dL

  Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus

Study Arms (1)

Tandem Freedom

EXPERIMENTAL

After a one week run-in period with Control-IQ technology, participants used the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses. Participants performed meal and exercise challenges in a supervised hotel setting.

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

Interventions

t:slim X2 insulin pump with Tandem Freedom Algorithm DEVICE

Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.

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.
• Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)

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

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: Manager, Clinical Affairs
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

8583666900

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care

  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: May 20, 2024
• First Posted: May 24, 2024
• Study Start: May 29, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)