Type 1 DiabetesPhase 1NCT01055951
Feasibility Study of the Solo™ Insulin Pump
A Phase 1 study testing Solo MicroPump in people with Type 1 Diabetes and Insulin Pump Users, run by Medingo Ltd at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Type 1 Diabetes, Insulin Pump Users
- What is being tested?
- Solo MicroPump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2009to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Israel2 sites
Rambam Healthcare Campus
Haifa, 31096
Sourasky Medical Center
Tel Aviv
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Insulin Pump Users
- Being tested
- Solo MicroPump
- Keywords
- Insulin pumps, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solo MicroPumpDevice
Also called Solo System
30 days treatment days with an optional extension period of up to 6 month of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Solo MicroPump | Experimental | Not described Receives: Device: Solo MicroPump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related adverse outcome
Measured: During treatment period
Secondary outcomes (1)
Mechanical dysfunction and diabetes-related adverse outcome
Measured: During treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medingo Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055951
- Sponsor's protocol ID
- VTR-045, VTR-075
- Status last verified
- Jun 2011
- First submitted
- 24 Jan 2010
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Solo™ Insulin Pump
- ClinicalTrials.gov ID
- NCT01055951
- Acronym / sponsor ID
- VTR-045, VTR-075
- Conditions
- Type 1 Diabetes, Insulin Pump Users
- Keywords
- Insulin pumps, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medingo LtdIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solo MicroPump | Experimental | Device: Solo MicroPump |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age range of:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solo MicroPumpAlso: Solo System30 days treatment days with an optional extension period of up to 6 month of treatment. | Device | Solo MicroPump |
Primary outcome
Device-related adverse outcome
Time frame: During treatment period
1 secondary outcome
Mechanical dysfunction and diabetes-related adverse outcome
Time frame: During treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Solo MicroPump in people with Type 1 Diabetes and Insulin Pump Users, run by Medingo Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related adverse outcome (time frame: During treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.