Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.

The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.

Study Overview

• Status: Completed
• Conditions: Type1diabetes
• Intervention / Treatment: Device: 7 day infusion set

Detailed Description

This is a 1-center, prospective, open label randomized, crossover controlled study.

40 patients will be using 4 infusion sets (a total of 160 sets) that will serve as an exploratory pilot study to assess the SD of 7 day use for future study design.

Eligible patients meeting the enrollment and randomization criteria will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for4 sets (up to 28 days). The order will be determined by the randomization process:

• Arm 1: Quick-EWIS. First phase Quickset, second phase EWIS.
• Arm 2: EWIS-Quick. First phase EWIS, second phase Quickset.

Following screening and informed consenting to the trial, a randomized procedure will define the subject trial arm:

• Trial Arm A: Subjects will be randomized to a group who will be using the Quickset infusion system for the Phase 1. All patients will be retrained on the use of the Quickset infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the X infusion set, entering Phase 2. All patients will be trained at this visit on the use of the X EW infusion set by site staff and demonstrate proficiency in the use of the EW infusion set. After 28 days or after using 4 sets, the patients will return all the extracted catheters sets .
• Trial Arm B: Subjects will be randomized to a group who will be using the EWIS set infusion system for the initial Phase. All patients will be trained on the use of the EWIS infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion set, entering Phase 2. All patients will then be retrained on the use of the Quickset infusion set by site staff and demonstrate proficiency. After 28 days or after using 4 sets, the patients will all the extracted catheters sets .

An extension phase for additional one month (4 sets) will be conducted as a single arm to assess the seven day durability of sets.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year
2. Using a MiniMed™ VEO pump or 640G Insulin pump with or without using an Enlite™ Sensor .
3. Age 18 to 80 years
4. Hemoglobin A1c level less than or equal to 10%
5. Not currently known to be pregnant, nor planning pregnancy during the study.
6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.

2. Pregnant or lactating females

   -

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: Trial Arm A; Quickset infusion system for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the 7 day set infusion set, entering Phase 2.	Device: 7 day infusion set; 7 days survival of the sets
Active Comparator: Trial Arm B; 7 day set infusion set for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion systems , entering Phase 2.	Device: 7 day infusion set; 7 days survival of the sets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary	• Percent of catheters reaching 4, 5, 6, 7 days use without set failure.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcomes	Exploratory investigation of correlation between glycemia as measured by CGM records and pressure measurements, as recorded by the insulin pump.; Descriptive of site reactions. Pain at the infusion site device related issues (leakage, occlusion in fluid path, etc.).; Descriptive of set failure cases: accidental pull out, adhesive tape issues, infection, erythema and/or induration.; Descriptive of catheter explants:Gross examination for cannula kinking and crimping.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Diabetic ketoacidosis (DKA); Severe hypoglycemia; Severe hyperglycemia; Serious adverse events (SAEs); Unanticipated adverse device effects (UADEs)	8 weeks

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 3, 2020
• Last Verified: May 1, 2020

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: 1.0

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: No