Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes

Detailed Description
-----------------
This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim to see whether there is a benefit to using an extended wear infusion set.

Official Title
-----------------
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: Extended Wear Infusion Set
* Device: Standard Infusion Set


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670G pump for at least 3 months Age ≥18 years Using Novolog or Humalog insulin at time of enrollment For females, not currently known to be pregnant An understanding of and willingness to follow the protocol and sign the informed consent Willing to have photographs taken of their infusion sites Willing to download their 670G pump every week to a research Carelink account Willing to submit a brief online questionnaire at the time of any infusion set failure Able to understand spoken or written English Hemoglobin A1c <8.5% at the time of enrollment Willing to perform three or more fingerstick glucose measurements each day Willing to sign a consent for release of medical information at the time of enrollment Willing to change their infusion pump insulin reservoirs at least every 6 days Exclusion Criteria: Hypoglycemic seizure or loss of consciousness in the past 6 months Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure A known cardiovascular disease Active proliferative diabetic retinopathy Known tape allergy Current treatment for a seizure disorder Cystic fibrosis Active infection A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol Inpatient psychiatric treatment in the past 6 months Presence of a known adrenal disorder If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the last 2 months prior to enrollment in the study Abuse of alcohol History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2 Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard then Extended Infusion Set<br>Participants will start with wearing the standard infusion set for up to 7 days, then switch to the Extended Wear infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks | Device: Extended Wear Infusion Set<br>* For two of the 4 weeks, the Extended Wear insulin infusion set will be used<br>Device: Standard Infusion Set<br>* For two of the 4 weeks, the standard insulin infusion set will be used<br>|
| Experimental: Extended then Standard Infusion Set<br>Participants will start with wearing the Extended Wear infusion set for up to 7 days, then switch to the standard infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks | Device: Extended Wear Infusion Set<br>* For two of the 4 weeks, the Extended Wear insulin infusion set will be used<br>Device: Standard Infusion Set<br>* For two of the 4 weeks, the standard insulin infusion set will be used<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infusion set failures due to unexplained hyperglycemia | Defined as: Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL Ketones ≥0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness) Evidence of infection at the infusion site (erythema or induration >1cm in diameter) Pump occlusion alarm | 14 days for each type of infusion set, with each type of infusion set worn twice | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of infusion set wear | The maximum number of days that 75% of the infusion sets are still working, excluding those that kinked on insertion or were accidentally pulled out. | 14 days for each type of infusion set, with each type of infusion set worn twice |