Diabetes Mellitus, Insulin-DependentPhase 3NCT01216618
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
A Phase 3 study testing InsuPatch in people with Diabetes Mellitus, Insulin-Dependent, run by Insuline Medical Ltd. at 3 sites in 2 countries.
Trial summary
The study is a prospective, multi-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- InsuPatch
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2010to Jun 2011
- Phase
- Phase 3
- 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
- Age between 18- 65 years old (including = 18 years and =65 years)
- Gender: men and women
- BMI: 18-35 kg/m2
- Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
- Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
- Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
- Subject is willing to comply with all specified follow-up evaluations -
Who cannot join
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
- Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
- Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic)
Show all 15Show fewer
- Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.
- Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
- Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L
- Psychological incompetence
- Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
- Subjects with diminished skin integrity
- Subjects with heat sensitivity
- Subjects involved in or planed to participate in other studies
- Subjects using other drugs therapies to control blood glucose level other than insulin.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Israel2 sites
Wolfson Medical Center
Holon
Haddasah Medical Organization
Jerusalem
United States1 site
Mills-Peninsula Health Services
San Mateo, California, 94401
About this study
The study is a prospective, multi-center, open label, randomized; two-arms cross over study.
This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.
Read the detailed description
Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
The study will be done with subjects randomized into one of two procedure sequences. Each subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be randomized into one sequence or the other. The order of the procedures will be selected randomly and will be performed both within one month.
There will be six Device visits starting with a screening and randomization visit, 3 clamps and a completion visit.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- InsuPatch
- Keywords
- MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.
- 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
the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Subject starts with two clamps including device use follows by a clamp without device use Receives: Device: InsuPatch |
| Control | No intervention | Subject starts with clamps without device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.
Measured: Up to 5 hours
Safety
frequency and severity of all treatment-related adverse events until the completion of the study.
Measured: Up to one month
Secondary outcomes (2)
pharmacokinetics
Cmax PK which is the highest concentration of insulin reached derived from blood samples collected at pre-specified time points during the glucose clamp test
Measured: Up to 5 hours
Pharmacodynamic
Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test
Measured: Up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- 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 Diabetes Mellitus, Insulin-DependentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insuline Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216618
- Sponsor's protocol ID
- G080106/A
- Status last verified
- Jun 2011
- First submitted
- 5 Oct 2010
- 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
- Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
- ClinicalTrials.gov ID
- NCT01216618
- Acronym / sponsor ID
- G080106/A
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Insuline Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Oct 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 study is a prospective, multi-center, open label, randomized; two-arms cross over study.
This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.
Detailed description
Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
The study will be done with subjects randomized into one of two procedure sequences. Each subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be randomized into one sequence or the other. The order of the procedures will be selected randomly and will be performed both within one month.
There will be six Device visits starting with a screening and randomization visit, 3 clamps and a completion visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: InsuPatchSubject starts with two clamps including device use follows by a clamp without device use |
| Control | No intervention | –Subject starts with clamps without device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18- 65 years old (including = 18 years and =65 years)
- Gender: men and women
- BMI: 18-35 kg/m2
- Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
- Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
Key exclusion criteria (15 listed)
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
- Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to 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 |
|---|---|---|
| InsuPatchthe InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure. | Device | Device |
Primary outcome
Efficacy
Time frame: Up to 5 hours
Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.
Safety
Time frame: Up to one month
frequency and severity of all treatment-related adverse events until the completion of the study.
2 secondary outcomes
pharmacokinetics
Time frame: Up to 5 hours
Pharmacodynamic
Time frame: Up to 5 hours
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.
- Sponsor's Official web siteLink 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.
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 3 study testing InsuPatch in people with Diabetes Mellitus, Insulin-Dependent, run by Insuline Medical 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 7 inclusion and 15 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 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy (time frame: Up to 5 hours). The study lists 2 primary outcomes in all. 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.