Performance Study of the SOLO 2.0 Insulin Pump
1 other identifier
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 11, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedDecember 29, 2011
December 1, 2011
1 year
December 11, 2011
December 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Device related safety issues
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
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
Device-related adverse outcome, such as significant skin irritation or infection at the attachment site
within the first month of use
Secondary Outcomes (3)
Diabetes-related adverse outcome
with in first month of use
Satisfaction iwth SOLO
within the first month of use
Product quality (MTBF)
within the first month of use
Interventions
Use of the SOLO insulin pump for treatment of type 1 diabetes.
Eligibility Criteria
You may qualify if:
- Age range:
- to 65 years (Graz)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medingo Ltdlead
Study Sites (2)
Schneider Medical Center
Petah Tikva, Israel
Sourasky Medical Center,
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Pieber, MD
Medical University of Graz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2011
First Posted
December 29, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Last Updated
December 29, 2011
Record last verified: 2011-12