Diabetes Mellitus, Type 1Phase 4Daily LifeNCT01283425
Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions
A Phase 4 study testing InsuPatch in people with Diabetes Mellitus, Type 1, run by Insuline Medical Ltd. at 8 sites in 2 countries.
Trial summary
The study is an open-label, randomized, two-period crossover study. Up to one hundred and twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed Consent will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- InsuPatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Feb 2011to Apr 2012
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's age range 18- 65 years old (including 18 and 65 years old)
- BMI: 18-35 kg/m2
- Type 1 diabetes patients using a MiniMed Paradigm insulin pump for at least six months, who are administering insulin Lispro or Insulin Aspart and are using the Quick-set infusion set.
- Patients with T1DM whose HbA1c values are at or below 9.5% (including 9.5%) and at or above 6% (including 6%).
- Agree to sign consent form before any study-specific tests or procedures are to be performed.
- Subject's completed at least 14 measurements during the Run-In Phase and readiness to continue the study with at least 5 blood glucose recordings per day and keep a logbook during the study period.
- Subject readiness to use the InsuPatch, his comprehension of the study requirements and treatment procedures.
- Willingness to comply with all specified follow-up evaluations.
Who cannot join
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date.
- CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date.
- Uncontrolled hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) .
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- Any history of gastroparesis or enteroparesis.
- Abnormal kidney and/ or liver function tests. (Defined as Creatinine >1.5 mg/dL, liver tests> 2 times the upper limit of normal).
- A severe hypoglycemic event requiring a glucagon injection or intravenous glucose infusion within the last six months prior to study inclusion.
- Hypoglycemia unawareness.
- Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion.
- Psychological incompetence.
- Signs of drug abuse.
- Any other clinical condition or history, which seems to be relevant for the Principle Investigator to disqualify a participant.
- Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites.
- Heat sensitive subjects.
- Subjects involved in or planning to participate in other studies.
- Subjects using any drug therapy, other than insulin, to control their blood glucose levels.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Israel7 sites
Soroka Medical Center
Beersheba
Hillel Yaffe
Hadera
Rambam Medical Center
Haifa
Wolfson Medical Center
Holon
Haddasah Medical Organization
Jerusalem
Schneider Children's hospital
Petah Tikva
Sheba Medical Center
Ramat Gan
United States1 site
Mills-Peninsula Health Services
San Mateo, California, 94401
About this study
Official title: An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.
The study is an open-label, randomized, two-period crossover study. Up to one hundred and twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed Consent will be enrolled in the study. The aim of the study is to examine the safety of the InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events will be compared between two phases of the study : 3 months with the use of the device and 3 months without the use of the device.
Read the detailed description
The primary objective of this study is to show that safety parameters are similar, when delivering insulin subcutaneously in subjects with type I diabetes using the InsuPatch device along with the Medtronic Minimed Paradigm insulin infusion pump and the Medtronic Minimed Quick-Set® infusion set compared to subcutaneous insulin delivered with the above mentioned equipment, without the InsuPatch device.
The participation of each subject in this study will be up to seven months and will include three phases: one week Run in phase , 3 months with device use and 3 months without device use. Study will include 4 clinic visits and bi weekly calls. During the entire study the subjects will be requested to preform at least 5 blood glucose self measurements and record results in a logbook.At each visit blood will be drawn for HBA1C test.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- InsuPatch
- Keywords
- MiniMed Paradigm insulin pump, insulin Lispro, Insulin Aspart, Quick-set infusion set
- 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.
InsuPatchDevice
Heaters for single use and a permanent control unit.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | InsuPatch use for 3 months. Receives: Device: InsuPatch |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without.
The confirmatory safety endpoint is, for each subject, frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without.
The number of events will be assessed from subject logbook and will be compared between two arms.
Measured: safety will be assesed after 6 months at the study completion
Secondary outcomes (2)
Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.
Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.The number of events will be assesed from subject logbook and will be compared between two arms.
Measured: safety will be assesed after 6 months at the study completion
Adverse events (AE's) count with InsuPatch and without.
Adverse events (AE's) whether or not deemed related to study device with InsuPatch and without.The number of events will be assesed dering the subject visits and bi-weekly calls and will be compared between two arms.
Measured: safety will be assesed after 6 months at the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insuline Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wainstein Julio, MD, Principal investigator, Wolfsom Medical Center, Holon, IsraelItamar Raz, MD, Principal investigator, Hadassah Medical OrganizationKlonoff David, MD, Principal investigator, Mills Peninsula Health ServicesNaim Shhada, MD, Principal investigator, Rambam Health Care CampusOrit Hamiel, MD, Principal investigator, Sheba Medical CenterMoshe Philips, MD, Principal investigator, Schnieder Children's Medical CenterAnat Yaffe, Md, Principal investigator, Hiullel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283425
- Sponsor's protocol ID
- G080106/B
- Acronym
- Daily Life
- Status last verified
- Apr 2012
- First submitted
- 19 Jan 2011
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.
- ClinicalTrials.gov ID
- NCT01283425
- Acronym / sponsor ID
- Daily Life / G080106/B
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- MiniMed Paradigm insulin pump, insulin Lispro, Insulin Aspart, Quick-set infusion set
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Insuline Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Jan 2011 (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 study is an open-label, randomized, two-period crossover study. Up to one hundred and twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed Consent will be enrolled in the study. The aim of the study is to examine the safety of the InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events will be compared between two phases of the study : 3 months with the use of the device and 3 months without the use of the device.
Detailed description
The primary objective of this study is to show that safety parameters are similar, when delivering insulin subcutaneously in subjects with type I diabetes using the InsuPatch device along with the Medtronic Minimed Paradigm insulin infusion pump and the Medtronic Minimed Quick-Set® infusion set compared to subcutaneous insulin delivered with the above mentioned equipment, without the InsuPatch device.
The participation of each subject in this study will be up to seven months and will include three phases: one week Run in phase , 3 months with device use and 3 months without device use. Study will include 4 clinic visits and bi weekly calls. During the entire study the subjects will be requested to preform at least 5 blood glucose self measurements and record results in a logbook.At each visit blood will be drawn for HBA1C test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: InsuPatchInsuPatch use for 3 months. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject's age range 18- 65 years old (including 18 and 65 years old)
- BMI: 18-35 kg/m2
- Type 1 diabetes patients using a MiniMed Paradigm insulin pump for at least six months, who are administering insulin Lispro or Insulin Aspart and are using the Quick-set infusion set.
- Patients with T1DM whose HbA1c values are at or below 9.5% (including 9.5%) and at or above 6% (including 6%).
- Agree to sign consent form before any study-specific tests or procedures are to be performed.
Key exclusion criteria (18 listed)
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date.
- CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date.
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 |
|---|---|---|
| InsuPatchHeaters for single use and a permanent control unit. | Device | Test |
Primary outcome
frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without.
Time frame: safety will be assesed after 6 months at the study completion
The confirmatory safety endpoint is, for each subject, frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without. The number of events will be assessed from subject logbook and will be compared between two arms.
2 secondary outcomes
Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.
Time frame: safety will be assesed after 6 months at the study completion
Adverse events (AE's) count with InsuPatch and without.
Time frame: safety will be assesed after 6 months at the study completion
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 4 Sep 2014.
- Related InfoLink provided by the sponsor.
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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.
Wainstein Julio, MD principal investigator
Wolfsom Medical Center, Holon, Israel
Itamar Raz, MD principal investigator
Hadassah Medical Organization
Klonoff David, MD principal investigator
Mills Peninsula Health Services
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing InsuPatch in people with Diabetes Mellitus, Type 1, run by Insuline Medical Ltd. at 8 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 8 inclusion and 18 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without. (time frame: safety will be assesed after 6 months at the study completion). 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 4 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.