Clinical trial NCT04284033: Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Official title: Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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. 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

Primary outcomes:
measure: Number of infusion set failures due to "unexplained hyperglycemia"
timeFrame: 14 days for each type of infusion set, with each type of infusion set worn twice
Secondary outcomes:
measure: Duration of infusion set wear
timeFrame: 14 days for each type of infusion set, with each type of infusion set worn twice
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References: