Tandem Freedom - Feasibility Trial 1

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Tandem Freedom - Feasibility Trial 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06428591
• Other study ID #: TP-0017517
• Secondary ID: U1111-1307-6267
• Status: Completed
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: June 10, 2024

Study information

• Verified date: June 2024
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• t:slim X2 insulin pump with Tandem Freedom Algorithm
Participants will use the Tandem Freedom system for 3 day/nights in a supervised hotel setting, performing meal and exercise challenges.

Locations

Country	Name	City	State
New Zealand	University of Otago	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Hypoglycemia events	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)	3 days
Primary	Diabetic Ketoacidosis events	Number of diabetic ketoacidosis events	3 days
Primary	Unanticipated adverse device effects	Number of unanticipated adverse device effects	3 days
Primary	Other serious device-related adverse events	Number of other serious device-related adverse events	3 days
Secondary	Percent Time <70 mg/dL, overall	CGM measured percent time <70 mg/dL, overall	3 days
Secondary	Percent Time <70 mg/dL, daytime	CGM measured percent time <70 mg/dL, during the daytime	3 days
Secondary	Percent Time <70 mg/dL, nighttime	CGM measured percent time <70 mg/dL, during the nighttime	3 days
Secondary	Percent Time <54 mg/dL, overall	CGM measured percent time <54 mg/dL, overall	3 days
Secondary	Percent Time <54 mg/dL, daytime	CGM measured percent time <54 mg/dL, during the daytime	3 days
Secondary	Percent Time <54 mg/dL, nighttime	CGM measured percent time <54 mg/dL, during the nighttime	3 days
Secondary	Percent Time in Range 70 - 180 mg/dL, overall	CGM measured percent time in range 70 - 180 mg/dL, overall	3 days
Secondary	Percent Time in Range 70 - 180 mg/dL, daytime	CGM measured percent time in range 70 - 180 mg/dL, daytime	3 days
Secondary	Percent Time in Range 70 - 180 mg/dL, nighttime	CGM measured percent time in range 70 - 180 mg/dL, nighttime	3 days
Secondary	Percent Time in Range 70 - 140 mg/dL, overall	CGM measured percent time in range 70 - 140 mg/dL, overall	3 days
Secondary	Percent Time in Range 70 - 140 mg/dL, daytime	CGM measured percent time in range 70 - 140 mg/dL, daytime	3 days
Secondary	Nighttime Percent between 70-140 mg/dL, nighttime	CGM measured percent time in range 70 - 140 mg/dL, nighttime	3 days
Secondary	Percent Time >180 mg/dL, overall	CGM measured percent time >180 mg/dL, overall	3 days
Secondary	Percent Time >180 mg/dL, daytime	CGM measured percent time >180 mg/dL, daytime	3 days
Secondary	Percent Time >180 mg/dL, nighttime	CGM measured percent time >180 mg/dL, nighttime	3 days
Secondary	Percent Time >250 mg/dL, overall	CGM measured percent time >250mg/dL, overall	3 days
Secondary	Daytime Percent time >250 mg/dL, daytime	CGM measured percent time >250mg/dL, daytime	3 days
Secondary	Nighttime Percent time >250 mg/dL, nighttime	CGM measured percent time >250mg/dL, nighttime	3 days
Secondary	Mean glucose (mg/dL), overall	CGM measured mean glucose (mg/dL), overall	3 days
Secondary	Mean glucose (mg/dL), daytime	CGM measured mean glucose (mg/dL), daytime	3 days
Secondary	Mean glucose (mg/dL), nighttime	CGM measured mean glucose (mg/dL), nighttime	3 days
Secondary	Glycemic Variability as assessed by Coefficient of Variation (%), overall	CGM measured Coefficient of Variation (%), overall	3 days
Secondary	Glycemic Variability as assessed by Coefficient of Variation (%), daytime	CGM measured Coefficient of Variation (%), daytime	3 days
Secondary	Glycemic Variability as assessed by Coefficient of Variation (%), nighttime	CGM measured Coefficient of Variation (%), nighttime	3 days
Secondary	Glycemic Variability as assessed by Standard Deviation (mg/dL), overall	CGM measured Standard Deviation (mg/dL), overall	3 days
Secondary	Glycemic Variability as assessed by Standard Deviation (mg/dL), daytime	CGM measured Standard Deviation (mg/dL), daytime	3 days
Secondary	Glycemic Variability as assessed by Standard Deviation (mg/dL), nighttime	CGM measured Standard Deviation (mg/dL), nighttime	3 days