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Type 1 DiabetesNCT01500928

Performance Study of the SOLO 2.0 Insulin Pump

A study testing SOLO insulin pump in people with Type 1 Diabetes, run by Medingo Ltd at 2 sites in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
SOLO insulin pump
Type of treatment
Medical device
How many people
40 participants
Where
2 sitesIsrael
Study dates
Jul 2011to Jul 2012
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age range:
  • 16 to 65 years (Graz)
  • 18 to 65 years (Israel)
  • Diabetic insulin pump user with diagnosis duration of more than 6 months.
  • Subjects who are using Humalog®, NovoRapid®/NovoLog or Apidra® 100U/ml in- - 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

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
Show all 12Show fewer
  • 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

2 sites in 1 country.

Andrea Berghofer contact

+ 43 316 385 80769

Israel2 sites, 2 recruiting

  • Schneider Medical Center

    Petah Tikva

    Alona Hamou

    Shlomit Shalitin, MD

    Recruiting

  • Sourasky Medical Center,

    Tel Aviv

    Miri MArgaliot, +972-3-697-3732

    Naftali Stern, PhD

    Recruiting

Other trials in Israel

About this study

The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment.

Read the detailed description

This is a multi center, one arm, open label and prospective study to assess the safety and quality of the SOLO 2.0 MicroPump Insulin Delivery System, following changes that were done to the SOLO previous version which was validated in 54 subjects.

SOLO 2.0 has the same intended use and core technology as previous SOLO with addition of safety measures, GUI changes and design changes for manufacturability.

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 three month in Israel and up to six month in Austria.

The study includes 3 scheduled treatment 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.

The study includes 3 scheduled treatment visits and one scheduled telephone call

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, 10 and 30 days after the enrolment. Additional visits will take place at 60, 90, 120 and 150 days depending on the extension period.

Medical assessment includes DTSQ information, Subject Diary, urine \& blood sampling, physical examination, the SOLO Performance Questionnaire, R\&D Questionnaire and Complaint Report Forms.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.

Conditions
Type 1 Diabetes
Being tested
SOLO insulin pump
Keywords
Insulin Pump, Glycemic Control, Type 1 Diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOLO insulin pumpDevice

    Use of the SOLO insulin pump for treatment of type 1 diabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device related safety issues

    Subject complaints documented in the R\&D questionnaire and Complaint Report Forms which were assessed and found to be device related safety issues.

    Measured: with in the first month of use

  2. SOLO use errors

    Use errors or potential use errors reported in Subject Diary which may be related to SOLO safety.

    Measured: within the first month of use

  3. Device-related adverse outcome

    Device-related adverse outcome, such as significant skin irritation or infection at the attachment site

    Measured: within the first month of use

Secondary outcomes (3)

  1. Diabetes-related adverse outcome

    Diabetes-related adverse outcome. i.e. hypoglycemia, hyperglycemia and diabetic ketoacidosis (DKA) events.

    Measured: with in first month of use

  2. Satisfaction iwth SOLO

    Subject satisfaction with SOLO as reported in:

    1. SOLO performance questionnaire
    2. DTSQ analysis

    Measured: within the first month of use

  3. Product quality (MTBF)

    Product quality will be assessed by Mean Time Between Failures (MTBF) calculation that include three types of failure modes:

    Type 1: Non-functional device Type 2: Dysfunction that can be recovered by the subject Type 3: Minor issues reported by the user

    Measured: within the first month of use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2012 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500928
Sponsor's protocol ID
VTR-135; VTR-075
Status last verified
Dec 2011
First submitted
11 Dec 2011
Last updated
29 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing SOLO insulin pump in people with Type 1 Diabetes, run by Medingo Ltd at 2 sites in Israel.

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 8 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: status not confirmed, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Berghofer (+ 43 316 385 80769), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device related safety issues (time frame: with in the first month of use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500928.

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 29 Dec 2011.

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