Tandem Freedom Feasibility Study 1

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06428591

Enrollment

Registered

2024-05-24

Start date

2024-05-29

Completion date

2024-06-10

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

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

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.

Detailed 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 1 day with boluses, and 1 day without boluses, 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.

Interventions

DEVICEt:slim X2 insulin pump with Tandem Freedom Algorithm

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Severe Hypoglycemia Events	Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
Diabetic Ketoacidosis Events	Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus	Number of diabetic ketoacidosis events

Secondary

Measure	Time frame	Description
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	CGM measured percent time in range 70 - 180 mg/dL
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	CGM measured percent time in range 70 - 140 mg/dL
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	CGM measured percent time \>180 mg/dL
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	CGM measured percent time \<54 mg/dL
Mean Glucose (mg/dL)	Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus	CGM measured mean glucose (mg/dL)
Glucose Coefficient of Variation (%)	Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus	CGM measured Coefficient of Variation (%)
Glucose Standard Deviation (mg/dL)	Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus	CGM measured Standard Deviation (mg/dL)
Percent Time >250 mg/dL	Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus	CGM measured percent time \>250mg/dL
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	CGM measured percent time \<70 mg/dL

Countries

New Zealand

Participant flow

Recruitment details

Ten adults with type 1 diabetes (all existing Control-IQ users) were recruited for this study.

Participants by arm

Arm	Count
t:Slim X2 Insulin Pump With Tandem Freedom Algorithm After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.	10
Total	10

Baseline characteristics

Characteristic	t:Slim X2 Insulin Pump With Tandem Freedom Algorithm
Age, Continuous	37.3 years STANDARD_DEVIATION 19.6
BMI at Enrollment	27.3 kg/m^2 STANDARD_DEVIATION 5.8
Duration of Diabetes	18.1 years STANDARD_DEVIATION 12.5
HbA1c at Enrollment	6.8 percentage of glycated hemoglobin STANDARD_DEVIATION 0.7
Number of DKA events in the last 6 months	0 DKA events
Number of severe hypoglycemic events (required assistance) in the last 6 months	0 Severe Hypoglycemic Events
Race/Ethnicity, Customized Maori	1 Participants
Race/Ethnicity, Customized New Zealand European	9 Participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	7 Participants
Total Daily Insulin Dose at Enrollment	62.3 units/day STANDARD_DEVIATION 22.7

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	1 / 10
serious Total, serious adverse events	0 / 10