Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Trial ID or NCT#
NCT04284033
Status
NOT RECRUITING
Purpose
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
Official Title
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. 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 months2. Age ≥18 years3. Using Novolog or Humalog insulin at time of enrollment4. For females, not currently known to be pregnant5. An understanding of and willingness to follow the protocol and sign the informed consent6. Willing to have photographs taken of their infusion sites7. Willing to download their 670G pump every week to a research Carelink account8. Willing to submit a brief online questionnaire at the time of any infusion set failure9. Able to understand spoken or written English10. Hemoglobin A1c \<8.5% at the time of enrollment11. Willing to perform three or more fingerstick glucose measurements each day12. Willing to sign a consent for release of medical information at the time of enrollment13. Willing to change their infusion pump insulin reservoirs at least every 6 days
Exclusion Criteria:
- 1. Hypoglycemic seizure or loss of consciousness in the past 6 months2. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure3. A known cardiovascular disease4. Active proliferative diabetic retinopathy5. Known tape allergy6. Current treatment for a seizure disorder7. Cystic fibrosis8. Active infection9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol10. Inpatient psychiatric treatment in the past 6 months11. Presence of a known adrenal disorder12. 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 study13. Abuse of alcohol14. History of dialysis, renal failure or known eGFR \<60 ml/min/1.73m215. Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
Investigator(s)
Rayhan A. Lal, MD
Endocrinologist
Assistant Professor of Medicine (Endocrinology) and of Pediatrics (Endocrinology)
Contact us to find out if this trial is right for you.
Contact
Liana Hsu, BS
650-725-3939
View on ClinicalTrials.gov
