Tandem Freedom - Feasibility Trial 1

Tandem Diabetes Care

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT06428591

TP-0017517

U1111-1307-6267 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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)

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 period of study participation
1. A negative pregnancy test will be required for all females of child-bearing potential
2. 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
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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Tandem Freedom

Experimental group

Description:

After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system for 3 days/nights.

Treatment:

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