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.
Device: Solo MicroPump
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01055951
Ages eligible for Study
16 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age range of:
18 to 60 years in Israel
16 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.
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
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
All locations for NCT01055951
Medical University Graz
Gratz, Austria, A - 8036
Rambam Healthcare Campus
Haifa, Israel, 31096
Sourasky Medical Center
View full eligibility
Tris trial is registered with FDA with number: NCT01055951. The sponsor of the trial is Medingo Ltd and it is looking for 90 volunteers for the current phase.
Official trial title: Feasibility Study of the Solo™ Insulin Pump
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