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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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. 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 months 2. Age ≥18 years 3. Using Novolog or Humalog insulin at time of enrollment 4. For females, not currently known to be pregnant 5. An understanding of and willingness to follow the protocol and sign the informed consent 6. Willing to have photographs taken of their infusion sites 7. Willing to download their 670G pump every week to a research Carelink account 8. Willing to submit a brief online questionnaire at the time of any infusion set failure 9. Able to understand spoken or written English 10. Hemoglobin A1c <8.5% at the time of enrollment 11. Willing to perform three or more fingerstick glucose measurements each day 12. Willing to sign a consent for release of medical information at the time of enrollment 13. Willing to change their infusion pump insulin reservoirs at least every 6 days
Exclusion Criteria:
  1. 1. Hypoglycemic seizure or loss of consciousness in the past 6 months 2. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure 3. A known cardiovascular disease 4. Active proliferative diabetic retinopathy 5. Known tape allergy 6. Current treatment for a seizure disorder 7. Cystic fibrosis 8. Active infection 9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 10. Inpatient psychiatric treatment in the past 6 months 11. Presence of a known adrenal disorder 12. 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 13. Abuse of alcohol 14. History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2 15. Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment


Rayhan A. Lal, MD
Rayhan A. Lal, MD
Assistant Professor of Medicine (Endocrinology) and of Pediatrics (Endocrinology)

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Liana Hsu, BS