Tandem Freedom - Feasibility Trial 1

Last updated: June 13, 2024
Sponsor: Tandem Diabetes Care, Inc.
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Treatment

t:slim X2 insulin pump with Tandem Freedom Algorithm

Clinical Study ID

NCT06428591
TP-0017517
U1111-1307-6267
  • Ages > 18
  • All Genders

Study 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 for 3 days/nights.

Eligibility Criteria

Inclusion

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 studydevices and is capable of adhering to the protocol, including performing the weekendhotel observed setting portion of the study.

  • Willing to use only aspart (novorapid) or lispro (humalog) insulin with the studypump, with no use of long-acting basal insulin injections, or inhaled insulin withthe study pump.

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

Exclusion

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 periodof study participation

  1. A negative pregnancy test will be required for all females of child-bearingpotential

  2. Counseling on appropriate birth control options will be provided to all femalesof child-bearing potential

  • Concurrent use of any non-insulin glucose-lowering agent, other than metformin (forexample, 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 tointerfere 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 ininvestigator's judgment) or hemodialysis

  • Concurrent use of any medication that could interfere with the study CGM, such ashydroxyurea

  • History of adrenal insufficiency

  • History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that isnot appropriately treated

  • History of gastroparesis

  • A condition, which in the opinion of the investigator or designee, would put theparticipant or study at risk

  • Participation in another pharmaceutical or device trial at the time of enrollment oranticipated 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 directlyinvolved in conducting the clinical trial (as a study investigator, coordinator,etc.); or having a first-degree relative who is directly involved in conducting theclinical trial

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: t:slim X2 insulin pump with Tandem Freedom Algorithm
Phase:
Study Start date:
May 29, 2024
Estimated Completion Date:
June 10, 2024

Study Description

After a 1 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 3 days/nights in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.

Connect with a study center

  • University of Otago

    Christchurch, 8140
    New Zealand

    Site Not Available

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