Feasibility Study of the Solo™ Insulin Pump
1 other identifier
interventional
90
2 countries
3
Brief Summary
The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2009
Typical duration for phase_1
3 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
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 24, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 2, 2011
June 1, 2011
2.1 years
January 24, 2010
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Device-related adverse outcome
During treatment period
Secondary Outcomes (1)
Mechanical dysfunction and diabetes-related adverse outcome
During treatment period
Study Arms (1)
Solo MicroPump
EXPERIMENTALInterventions
30 days treatment days with an optional extension period of up to 6 month of treatment.
Eligibility Criteria
You may qualify if:
- Age range of:
- to 60 years in Israel
- to 60 years in Austria
- Type I diabetes and pump treatment duration of more than 6 months.
- Subjects who are using Humalog®, NovoRapid®, and Apidra® 100U/ml insulin
- 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 (3)
Medical University Graz
Gratz, A - 8036, Austria
Rambam Healthcare Campus
Haifa, 31096, Israel
Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2010
First Posted
January 26, 2010
Study Start
May 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 2, 2011
Record last verified: 2011-06