Overview
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Description
All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.
The 2 treatment arms are:
Existing t:slim X2 Users:
- t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
- t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)
Existing Mobi Users:
- Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
- Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
Eligibility
Inclusion Criteria:
- Age 18 to 80 years old inclusive
- Generally in good health, as determined by the investigator
- Living in the United States with no plans to move outside the United States during the study
- Diagnosis of T1D for at least 12 months
- Currently using a Tandem pump
- Current Dexcom CGM user
- HbA1c \<9.0% in the last 6 months.
- Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
- Willing to wear each investigational infusion set for up to 7 days during each of the wear periods in the study
- Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
- If using Tandem Mobi, has a compatible cellular phone that can run the Tandem Mobi Mobile App
- BMI in the range 18-35 kg/m2, both inclusive
- Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
- Humalog™ (or generic insulin lispro)
- NovoLog™ (or generic insulin aspart)
- Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
- Has the ability to understand and comply with protocol procedures and to provide informed consent
Exclusion Criteria:
- 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)
- Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
- Episodes of severe hypoglycemia in the last 6 months resulting in:
- Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
- Loss of consciousness
- Seizures
- One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
- 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
- Known history of any of the following conditions:
- Cushing's Disease
- Adrenal insufficiency
- Pancreatic islet cell tumor
- Insulinoma
- Lipodystrophy
- Extensive lipohypertrophy, as assessed by the investigator
- Undergoing treatment with systemic oral or intravenous corticosteroids, at or within the last 8 weeks from screening. Inhaled glucocorticoids are allowed.
- Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
- Alcoholism
- Drug abuse
- Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
- Current participation in another clinical drug or device study
- 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 Tandem Diabetes Care
