Performance Study of the SOLO 2.0 Insulin Pump

December 25, 2011 updated by: Medingo Ltd
The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a multi center, one arm, open label and prospective study to assess the safety and quality of the SOLO 2.0 MicroPump Insulin Delivery System, following changes that were done to the SOLO previous version which was validated in 54 subjects.

SOLO 2.0 has the same intended use and core technology as previous SOLO with addition of safety measures, GUI changes and design changes for manufacturability.

The study will include a 30 days treatment period with the Solo MicroPump with no special care required for maintaining glycemic control and with an optional extension period of up to three month in Israel and up to six month in Austria.

The study includes 3 scheduled treatment and one follow up phone call one week after termination of the study. In case of participating the extension period, additional visits will consist once a month.

The study includes 3 scheduled treatment visits and one scheduled telephone call

Visit 1 includes eligibility, baseline evaluation and training in handling of the SOLO System. If no additional practice is required patients will be enrolled. Visit 2 will commence and Solo pump will be filled with insulin. If additional practice is required subject will be sent home for an additional training period of a few days practice using saline and then return for visit 2.

Treatment visits will take place at 3, 10 and 30 days after the enrolment. Additional visits will take place at 60, 90, 120 and 150 days depending on the extension period.

Medical assessment includes DTSQ information, Subject Diary, urine & blood sampling, physical examination, the SOLO Performance Questionnaire, R&D Questionnaire and Complaint Report Forms.Subjects will be asked to record blood glucose measurements, daily activities and carbohydrate consumptions between visits.

Seven days after termination of study treatment a telephone contact with the study subject will take place for the purpose of adverse event reporting and the completion of DTSQ questionnaire.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrea Berghofer
  • Phone Number: + 43 316 385 80769

Study Locations

      • Petach Tikva, Israel
        • Recruiting
        • Schneider Medical Center
        • Contact:
          • Alona Hamou
        • Principal Investigator:
          • Shlomit Shalitin, MD
      • Tel Aviv, Israel
        • Recruiting
        • Sourasky Medical Center,
        • Contact:
          • Miri MArgaliot
          • Phone Number: +972-3-697-3732
        • Principal Investigator:
          • Naftali Stern, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range:
  • 16 to 65 years (Graz)
  • 18 to 65 years (Israel)
  • Diabetic insulin pump user with diagnosis duration of more than 6 months.
  • Subjects who are using Humalog®, NovoRapid®/NovoLog or Apidra® 100U/ml in- - Measures glucose at least four times per day.
  • No more than one severe hypoglycemic or ketoacidosis episode within one year
  • Willing to sign an informed consent.
  • Cooperative, willing to attend all study visits

Exclusion Criteria:

  • A1c >= 10.0%
  • Two or more documented events of severe hypoglycemia within the previous 12 months
  • Diabetes related hospitalization over the past 12 months
  • Current significant diabetes-related complications
  • Pregnant, lactating or planning to become pregnant during the course of the study
  • Substance or alcohol abuse
  • Uncontrolled hypertension
  • Known dermal hypersensitivity to medical adhesive
  • Recurrent episodes of skin infections or dermatological allergies
  • Serious or unstable medical or psychological conditions
  • Current participation in other clinical studies.
  • Working for a competitor company

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device related safety issues
Time Frame: with in the first month of use
Subject complaints documented in the R&D questionnaire and Complaint Report Forms which were assessed and found to be device related safety issues.
with in the first month of use
SOLO use errors
Time Frame: within the first month of use
Use errors or potential use errors reported in Subject Diary which may be related to SOLO safety.
within the first month of use
Device-related adverse outcome
Time Frame: within the first month of use
Device-related adverse outcome, such as significant skin irritation or infection at the attachment site
within the first month of use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes-related adverse outcome
Time Frame: with in first month of use
Diabetes-related adverse outcome. i.e. hypoglycemia, hyperglycemia and diabetic ketoacidosis (DKA) events.
with in first month of use
Satisfaction iwth SOLO
Time Frame: within the first month of use

Subject satisfaction with SOLO as reported in:

  1. SOLO performance questionnaire
  2. DTSQ analysis
within the first month of use
Product quality (MTBF)
Time Frame: within the first month of use

Product quality will be assessed by Mean Time Between Failures (MTBF) calculation that include three types of failure modes:

Type 1: Non-functional device Type 2: Dysfunction that can be recovered by the subject Type 3: Minor issues reported by the user

within the first month of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

December 11, 2011

First Submitted That Met QC Criteria

December 25, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 25, 2011

Last Verified

December 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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