Feasibility Study of the Solo™ Insulin Pump
Primary Purpose
Type 1 Diabetes, Insulin Pump Users
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Solo MicroPump
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin pumps, Diabetes
Eligibility Criteria
Inclusion Criteria:
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.
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
Sites / Locations
- Medical University Graz
- Rambam Healthcare Campus
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solo MicroPump
Arm Description
Outcomes
Primary Outcome Measures
Device-related adverse outcome
Secondary Outcome Measures
Mechanical dysfunction and diabetes-related adverse outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01055951
Brief Title
Feasibility Study of the Solo™ Insulin Pump
Official Title
Feasibility Study of the Solo™ Insulin Pump
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medingo Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a multi center, one arm, open label and prospective study to assess the safety and usability of the Solo™ MicroPump Insulin Delivery System .
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 six month.
The study will consist of up to 5 visits 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.
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, 14 and 30 days after the enrolment. Additional visits will take place at 60, 90 and 180 days depending on the extension period.
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.
Measurements that will be used for assessing the safety of the device are glucose levels and any occurrence of AE's.
Subjects will complete DTSQ and Performance questionnaires before and at the end of the treatment period for usability evaluation.
Blood and urine tests will be taken at visit 1 and 5, vital signs and physical examination will be evaluated at all study visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Insulin Pump Users
Keywords
Insulin pumps, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Solo MicroPump
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Solo MicroPump
Other Intervention Name(s)
Solo System
Intervention Description
30 days treatment days with an optional extension period of up to 6 month of treatment.
Primary Outcome Measure Information:
Title
Device-related adverse outcome
Time Frame
During treatment period
Secondary Outcome Measure Information:
Title
Mechanical dysfunction and diabetes-related adverse outcome
Time Frame
During treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Facility Information:
Facility Name
Medical University Graz
City
Gratz
ZIP/Postal Code
A - 8036
Country
Austria
Facility Name
Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of the Solo™ Insulin Pump
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