Status:
WITHDRAWN
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Medtronic
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04284033
Start Date
February 14 2017
End Date
April 20 2018
Last Update
September 2 2021
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304