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

NCT ID: NCT04284033

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2018-04-20

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard then Extended Infusion Set

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

Group Type: EXPERIMENTAL

Extended Wear Infusion Set

Intervention Type: DEVICE

For two of the 4 weeks, the Extended Wear insulin infusion set will be used

Standard Infusion Set

Intervention Type: DEVICE

For two of the 4 weeks, the standard insulin infusion set will be used

Extended then Standard Infusion Set

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

Group Type: EXPERIMENTAL

Extended Wear Infusion Set

Intervention Type: DEVICE

For two of the 4 weeks, the Extended Wear insulin infusion set will be used

Standard Infusion Set

Intervention Type: DEVICE

For two of the 4 weeks, the standard insulin infusion set will be used

Interventions

Extended Wear Infusion Set

For two of the 4 weeks, the Extended Wear insulin infusion set will be used

Intervention Type: DEVICE

Standard Infusion Set

For two of the 4 weeks, the standard insulin infusion set will be used

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce Buckingham

Professor Emeritus, Pediatrics - Endocrinology and Diabetes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

52526

Identifier Type: -

Identifier Source: org_study_id