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

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

Study Overview

• Status: Withdrawn
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Extended Wear Infusion Set; Device: Standard Infusion Set

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Extended Wear Infusion Set; For two of the 4 weeks, the Extended Wear insulin infusion set will be used; Device: Standard Infusion Set; For two of the 4 weeks, the standard insulin infusion set will be used
Experimental: 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	Device: Extended Wear Infusion Set; For two of the 4 weeks, the Extended Wear insulin infusion set will be used; Device: Standard Infusion Set; For two of the 4 weeks, the standard insulin infusion set will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infusion set failures due to "unexplained hyperglycemia"	Defined as: Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL; Ketones ≥0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness); Evidence of infection at the infusion site (erythema or induration >1cm in diameter); Pump occlusion alarm	14 days for each type of infusion set, with each type of infusion set worn twice

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of infusion set wear	The maximum number of days that 75% of the infusion sets are still working, excluding those that kinked on insertion or were accidentally pulled out.	14 days for each type of infusion set, with each type of infusion set worn twice

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): November 10, 2017
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 22, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 52526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes