Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes

Type1diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273124
• Other study ID #: 150-1261-00
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: January 15, 2025

Study information

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

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Device:
• SteadiSet Extended Wear Infusion Set
Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Henry Ford Health System	Detroit	Michigan
United States	Northwestern University	Evanston	Illinois
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	International Diabetes Center - HealthPartners Institute	Minneapolis	Minnesota
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Mayo Clinic	Rochester	Minnesota
United States	Endocrine Research Solutions	Roswell	Georgia
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.	Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	Rate of infusion set failure at the end of 7 days in participants taking Novolog	168 hours
Primary	Primary Outcome	Rate of infusion set failure at the end of 7 days in participants taking Humalog	168 hours