DiabetesNCT01114061
Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the InsuPatch Device During Daily Life
A study testing Insupatch in people with Diabetes, run by Insuline Medical Ltd..
Trial summary
The aim of this study is to test the performance of the InsuPatch device in daily life. The primary target of the study is to evaluate safety aspect of daily device use. Additional aspects to be evaluated in the study are: the effect of the device on post prandial glucose level. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant age between 18- 65 years old (including = 18 years and =65 years)
- BMI: 18-35 kg/m2
- Insulin dependent diabetes under insulin pumps.
- Use of short-acting insulin analogues
- Subjects agreeing to use the InsuPatch device.
- 6% ≤ HbA1c ≤ 9.5%
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- Agree to sign consent form.
- Subject is willing to do at least 4 blood glucose recordings per day
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- Willing to comply with all specified follow-up evaluations
Who cannot join
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- Had CABG (Coronary Artery Bypass Graft), Post MI (Myocardial Infarction) or had active Ischemic heart disease in the last 3 months prior to the study date
- Had CVA (cardiovascular accident) or TIA (transient ischemic accident) in the last 12 months prior to the study
- Suffer from Hypertension (blood pressure > 140/90) .
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- Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.
- Known gastro- or enteroparesis
- Abnormal kidney and/ or liver function tests. (Creatinine >1.5 mg/dL, liver test> 2 times the upper limit of the normal range).
- Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last six months prior to study inclusion
- Hypoglycaemia 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, that seems to be relevant to the principle investigator to disqualify the participant.
- Not willing to sign the inform consent form.
- Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites
- Subjects with heat sensitivity
- Subjects involved in or planed to participate in other studies.
- Any subject whom the primary researcher consider not suited to the study.
About this study
The aim of this study is to test the performance of the InsuPatch device in daily life. The primary target of the study is to evaluate safety aspect of daily device use. Additional aspects to be evaluated in the study are: the effect of the device on post prandial glucose level.
Read the detailed description
Despite the recent years advance in rapid acting insulin analogues early postprandial hyperglycemia and late post prandial hypoglycemia are still common in insulin treated diabetic patients. It appears that even with these rapid acting insulins there is still a significant delay time and variability in the delay time between the changes in blood glucose levels following the meals and the absorption kinetics of insulin injected subcutaneously. Past studies using regular human insulin have demonstrated that using local stimulation at the injection site can dramatically improve regular insulin kinetics. The assumption was that local stimulation induces local increase in blood perfusion which improves insulin absorption from the injection site.
Following the above Insulin has developed the InsuPatch device. The intended use of the InsuPatch device 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.
The InsuPatch device consists of two components:
- InsuPatch single-use, flat, heating pad with electrical wire which is attached by adhesive to the bottom of the Medtronic MiniMed Quick-set® infusion set. The user attaches the device to the infusion set prior to insertion of the infusion set catheter.
II) The InsuPatch case is used as a case for the Medtronic MiniMed Paradigm insulin infusion pump. The InsuPatch case contains an electronic unit and batteries.
The effect of the device on the pharmacokinetics (PK) and pharmacodynamics (PD) of the injected insulin were tested in Euglycemic clamp and meal tolerance test (MTT) studies. The effect of the device on insulin PK was evaluated by comparing insulin concentration in the meal MTT study with and without operation of the device. The effect of the device on insulin PD was evaluated using Euglycemic clamp protocol with and without operation of the device. The effect of the device on postprandial glucose excursions was tested by comparing the post meal glucose levels with and without operation of the device.
The main results of the study were:
- An increase of 49% in the available insulin in the blood during the first 30 minutes post injection and 37% in during the first hour post injection (PK).
- A reduction of 25% in the average glucose level during post-meal first two hours (PD).
- A reduction of 43% in the time to peak action of insulin (PD).
The aim of this study is to test the performance of the InsuPatch device in daily life. The primary target of the study is to evaluate safety aspect of daily device use. Additional aspects to be evaluated in the study are: the effect of the device on post prandial glucose level.
- Conditions
- Diabetes
- Being tested
- Insupatch
- Keywords
- diabetes, postprandial glucose level, insulin pharmacodynamics, Insulin Pharmacokinetics
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsupatchDevice
Applying heat to the infusion site using the insupatch device
| Study group | Role | What they receive |
|---|---|---|
| InsuPatch | Experimental | The arm with the treatment: using the insupatch device to heat the insulin infusion site. Receives: Device: Insupatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
show no increase in hypoglycemia events when the InsuPatch device is used compared to the number of hypoglycemia events when the InsuPatch device is not used.
Show that the hypoglycemia rate is not increased when the InsuPatch device is used
Measured: three month with the device and three months without the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insuline Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114061
- Sponsor's protocol ID
- HT4813
- Status last verified
- Jun 2011
- First submitted
- 29 Apr 2010
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the InsuPatch Device During Daily Life
- ClinicalTrials.gov ID
- NCT01114061
- Acronym / sponsor ID
- HT4813
- Conditions
- Diabetes
- Keywords
- diabetes, postprandial glucose level, insulin pharmacodynamics, Insulin Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insuline Medical Ltd.Industry (pharma, biotech, devices)
- First posted
- 30 Apr 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 aim of this study is to test the performance of the InsuPatch device in daily life. The primary target of the study is to evaluate safety aspect of daily device use. Additional aspects to be evaluated in the study are: the effect of the device on post prandial glucose level.
Detailed description
Despite the recent years advance in rapid acting insulin analogues early postprandial hyperglycemia and late post prandial hypoglycemia are still common in insulin treated diabetic patients. It appears that even with these rapid acting insulins there is still a significant delay time and variability in the delay time between the changes in blood glucose levels following the meals and the absorption kinetics of insulin injected subcutaneously. Past studies using regular human insulin have demonstrated that using local stimulation at the injection site can dramatically improve regular insulin kinetics. The assumption was that local stimulation induces local increase in blood perfusion which improves insulin absorption from the injection site.
Following the above Insulin has developed the InsuPatch device. The intended use of the InsuPatch device 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.
The InsuPatch device consists of two components:
- InsuPatch single-use, flat, heating pad with electrical wire which is attached by adhesive to the bottom of the Medtronic MiniMed Quick-set® infusion set. The user attaches the device to the infusion set prior to insertion of the infusion set catheter.
II) The InsuPatch case is used as a case for the Medtronic MiniMed Paradigm insulin infusion pump. The InsuPatch case contains an electronic unit and batteries.
The effect of the device on the pharmacokinetics (PK) and pharmacodynamics (PD) of the injected insulin were tested in Euglycemic clamp and meal tolerance test (MTT) studies. The effect of the device on insulin PK was evaluated by comparing insulin concentration in the meal MTT study with and without operation of the device. The effect of the device on insulin PD was evaluated using Euglycemic clamp protocol with and without operation of the device. The effect of the device on postprandial glucose excursions was tested by comparing the post meal glucose levels with and without operation of the device.
The main results of the study were:
- An increase of 49% in the available insulin in the blood during the first 30 minutes post injection and 37% in during the first hour post injection (PK).
- A reduction of 25% in the average glucose level during post-meal first two hours (PD).
- A reduction of 43% in the time to peak action of insulin (PD).
The aim of this study is to test the performance of the InsuPatch device in daily life. The primary target of the study is to evaluate safety aspect of daily device use. Additional aspects to be evaluated in the study are: the effect of the device on post prandial glucose level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InsuPatch | Experimental | Device: InsupatchThe arm with the treatment: using the insupatch device to heat the insulin infusion site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant age between 18- 65 years old (including = 18 years and =65 years)
- BMI: 18-35 kg/m2
- Insulin dependent diabetes under insulin pumps.
- Use of short-acting insulin analogues
- Subjects agreeing to use the InsuPatch device.
Key exclusion criteria (20 listed)
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- Had CABG (Coronary Artery Bypass Graft), Post MI (Myocardial Infarction) or had active Ischemic heart disease in the last 3 months prior to the study date
- Had CVA (cardiovascular accident) or TIA (transient ischemic accident) in the last 12 months 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 |
|---|---|---|
| InsupatchApplying heat to the infusion site using the insupatch device | Device | InsuPatch |
Primary outcome
show no increase in hypoglycemia events when the InsuPatch device is used compared to the number of hypoglycemia events when the InsuPatch device is not used.
Time frame: three month with the device and three months without the device
Show that the hypoglycemia rate is not increased when the InsuPatch device is used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Insupatch in people with Diabetes, run by Insuline Medical Ltd..
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 10 inclusion and 20 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: paused, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
show no increase in hypoglycemia events when the InsuPatch device is used compared to the number of hypoglycemia events when the InsuPatch device is not used. (time frame: three month with the device and three months without the device). 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 13 Sep 2012.