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Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes
Recruiting
I'm InterestedTrial ID: NCT06273124
Purpose
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
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
Stanford Investigator(s)
Rayhan A. Lal, MD
Assistant Professor of Medicine (Endocrinology) and of Pediatrics (Endocrinology)
Michael Samuel Hughes
Instructor, Medicine - Endocrinology, Gerontology, & Metabolism
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 serum 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 insulin lispro or aspart for a minimum of 3 months 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
Intervention(s):
device: SteadiSet Extended Wear Infusion Set
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rayhan Lal
925-727-1317