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

Stanford University

Status: Withdrawn

Conditions: Type 1 Diabetes

Treatments: Device: Extended Wear Infusion Set; Device: Standard Infusion Set

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04284033

52526

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard then Extended Infusion Set

Experimental group

Description:

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

Treatment:

Device: Standard Infusion Set

Device: Extended Wear Infusion Set

Extended then Standard Infusion Set

Experimental group

Description:

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

Treatment:

Device: Standard Infusion Set

Device: Extended Wear Infusion Set