Feasibility Study of the Solo™ Insulin Pump

This study has been completed.
Sponsor:
Information provided by:
Medingo Ltd
ClinicalTrials.gov Identifier:
NCT01055951
First received: January 24, 2010
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Insulin Pump Users
Device: Solo MicroPump
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of the Solo™ Insulin Pump

Resource links provided by NLM:


Further study details as provided by Medingo Ltd:

Primary Outcome Measures:
  • Device-related adverse outcome [ Time Frame: During treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mechanical dysfunction and diabetes-related adverse outcome [ Time Frame: During treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: May 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solo MicroPump Device: Solo MicroPump
30 days treatment days with an optional extension period of up to 6 month of treatment.
Other Names:
  • Solo MicroPump
  • Solo System

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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055951

Locations
Austria
Medical University Graz
Gratz, Austria, A - 8036
Israel
Rambam Healthcare Campus
Haifa, Israel, 31096
Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Medingo Ltd
  More Information

No publications provided

Responsible Party: Keren Afek, Medingo
ClinicalTrials.gov Identifier: NCT01055951     History of Changes
Other Study ID Numbers: VTR-045, VTR-075
Study First Received: January 24, 2010
Last Updated: June 1, 2011
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by Medingo Ltd:
Insulin pumps
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014