Clinical trial NCT06273124: Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes
Official title: Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2024-02-22
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).

Participants will be asked to:

1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour

Detailed description: This is a multi-center, single-arm, prospective study of an extended wear infusion set in adults with Type 1 diabetes using a Tandem t:slim X2 insulin pump with Control-IQ technology with continuous Glucose Monitoring (CGM). Up to 300 participants across the United States age 18-80 will be enrolled in up to 20 investigational centers. Participants will change insulin cartridge every 48 to 72 hours as recommended by their health care provider. Participants will be expected to participate in the study for approximately 12-16 weeks.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  1. Age 18 to 80 years old inclusive
  2. Generally in good health, as determined by the investigator
  3. Living in the United States with no plans to move outside the United States during the study
  4. Diagnosis of T1D for at least 12 months
  5. Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
  6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
  7. Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active
  8. HbA1c \<9.0% in the last 6 months.
  9. Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
  10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study
  11. Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
  12. Access to internet for required periodic uploads of study device data
  13. BMI in the range 18-35 kg/m2, both inclusive
  14. Currently using one of the following insulins with no expectation of a need to change insulin type during the study:

      1. Humalog™\* (insulin lispro)
      2. NovoLog™\* (insulin aspart)
  15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment
  16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
  17. Has routine access to a smart phone e.g., ability to receive text messages
  18. Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., English proficient in both verbal and written communication)

Exclusion Criteria:

1. 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)
2. Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
3. Episodes of severe hypoglycemia in the last 6 months resulting in:

   1. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
   2. Loss of consciousness
   3. Seizures
4. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
5. Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period
6. Known cardiovascular disease considered to be clinically relevant by the investigator
7. Known history of any of the following conditions:

   1. Cushing's Disease
   2. Pancreatic islet cell tumor
   3. Insulinoma
   4. Lipodystrophy
   5. Extensive lipohypertrophy, as assessed by the investigator
8. Currently undergoing treatment with:

   1. Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
   2. Thyroid hormones, unless use has been stable during the past 3 months
9. Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:

   1. Alcoholism
   2. Drug abuse
10. Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
11. Current participation in another clinical drug or device study
12. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Capillary Biomedical

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 168 hours
measure: Primary Outcome
timeFrame: 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center - HealthPartners Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Capillary Biomedical
name: Alayne Lehman, RN, MS
role: STUDY_DIRECTOR
References: