- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01500928
Performance Study of the SOLO 2.0 Insulin Pump
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTR-135; VTR-075
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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