Diabetes Mellitus, Type 1
Conditions
Keywords
type 1 diabetes, T1D, Tandem, t:slim X2, Tandem Mobi, automated insulin delivery, SteadiSet
Brief summary
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Detailed 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)
Interventions
DEVICESteadiSet Infusion Set
Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.
Sponsors
Tandem Diabetes Care, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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: 1. Humalog™ (or generic insulin lispro) 2. 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: 1. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization) 2. Loss of consciousness 3. 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: 1. Cushing's Disease 2. Adrenal insufficiency 3. Pancreatic islet cell tumor 4. Insulinoma 5. Lipodystrophy 6. 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: 1. Alcoholism 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Survival of Infusion Set for Primary Outcome Measure | 6 weeks | 7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised) |
Countries
United States
Contacts
STUDY_DIRECTORJordan Pinsker, MD
Tandem Diabetes Care
Outcome results
None listed