Diabetes MellitusNCT02306343
Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device
A study testing InsuPad in people with Diabetes Mellitus, run by Insuline Medical Ltd. at 1 site in Israel.
Trial summary
The study is an open-label, randomized, two-period, one-way crossover study using the Meal Tolerance Test (MTT) protocol or the daily life setting protocol. The study consists of two parts. Subject may participate in both parts or just in one part. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- InsuPad
- 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
- 1 siteIsrael
- Study dates
- Nov 2011to Sep 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant age above 18 (including = 18 years)
- BMI above 18kg/m2
- Insulin dependent diabetes using insulin injections
- Diabetic patients with HbA1c values below 12%
- Participant understands the study requirements and the treatment procedures ,willing to comply with all specified follow-up evaluations and provides written Informed Consent before any study-specific tests or procedures are performed
Who cannot join
- Pregnancy
- Breast feeding women
- Alcohol addiction
- Had Coronary Artery Bypass Graft, are Post Myocardial Infarction or had active Ischemic heart failure in the last 3 months prior to the study date
- Had cardiovascular accident or transient ischemic accident in the last 12 months prior to the study
- Suffer from uncontrolled Hypertension (blood pressure > 165/90)
Show all 12Show fewer
- Low blood hemoglobin concentration <9 g/dL for female and <12g/dL for male)
- Low Hematocrit concentration <36%; Abnormal kidney and/ or liver function tests. (Creatinine >2 , liver test> 3 times the upper limit of the normal range)
- 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 planned to participate in other studies that may interfere in data collection.
Trial locations and contacts
1 site in 1 country.
About this study
The study is an open-label, randomized, two-period, one-way crossover study using the Meal Tolerance Test (MTT) protocol or the daily life setting protocol.
The study consists of two parts. Subject may participate in both parts or just in one part.
Read more
The first part tests the effect of local heating on the post prandial glucose levels following a bolus at in-patient settings.Type I and type II diabetic patients on basal bolus insulin therapy admitted after overnight fast for a meal tolerance test. Subjects injected 0.2 units/kg and consumed standardized liquid meal. Blood samples for glucose and insulin measurements was taken from a venous line. The study was conducted twice with (test) and without (control) the use of the InsuPad device.
The second part evaluate the safety and efficacy of the device use at daily life settings. Type I and type II diabetic patients enrolled to the study. They will be required to perform at least 3 self monitored blood glucose (SMBG) measurements. Study length is up to 25 months. Up to one month run in period, up to 12 months with the device (test) and up to 12 months without the device (control).The subjects will be asked to record events of hypoglycemia, hyperglycemia and any adverse events related to diabetes or the study.
Read the detailed description
The effect of the InsuPad device was studied using the Meal Tolerance Test protocol or the daily life setting protocol. In the Meal Tolerance Test protocol subjects consumed a standardized liquid meal taken immediately after injection of insulin bolus (0.2 units/kg body weight). Each subject went through the same Meal Tolerance Test protocol twice, once with the InsuPad device (test conditions) and again without the InsuPad device (control conditions) in randomized order. The study started after an overnight fast and stabilization period in which the subject glucose level was stabilized between 100-150 mg/dl, using I.V glucose solution/oral glucose or intravenous insulin administration if needed. The patient remained stable (change of glucose level <20mg/dl) without any intervention or infusion 30 min prior to the study. Blood glucose measurements were taken from a peripheral venous at pre-specified time points. Total follow up time was 5 hours post meal. Safety limits of the study were 75 mg/dl as the low limit and 300 mg/dl as the high limit. If the subject's blood glucose level was below 75 mg/dl glucose solution was given orally to increase his blood glucose level. If subjects blood glucose was above 300 mg/dl iv insulin was given to reduce blood glucose level.
In the daily life setting protocol subjects meeting the inclusion exclusion criteria enrolled to the study. Study length was up to 25 months. Up to one month run in period, up to 12 months with the device (test) and up to 12 months without the device (control). Subjects were asked to perform at least 3 blood glucose measurements a day. Subjects were asked to fill logbooks with measured blood glucose levels and insulin doses given during the whole study. Subjects were asked to report any adverse event during the study. The subjects received a tutorial about the device usage and the study procedures. The order of the test and control phases was randomly selected.
- Conditions
- Diabetes Mellitus
- Being tested
- InsuPad
- Keywords
- rapid acting insulin, insulin injection, insulin delivery, local heating, experimental device, pre and post meal glucose level
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsuPadDevice
The InsuPad device is composed of a disposable heating pad and a reusable control unit. The heating pad is intended for one day use. The user would attach the InsuPad device to a site where insulin can be injected. When there is a need for insulin bolus injection the user would inject the insulin to a location designate for that. The device would start heating the area around the injection site without over heating the insulin. At the end of the day the subject would remove the device, dispose of the disposable unit and put the reusable unit for recharging.
| Study group | Role | What they receive |
|---|---|---|
| Test (with the InsuPad device) | Experimental | In the Meal Tolerance Test protocol - After overnight fast followed by a pre-study stabilization period, the InsuPad device was placed on the abdomen of the subject. The InsuPad device was activated and insulin bolus (0.2 units/kg body weight) was injected right before study start. The injection was given to the subject's abdomen through the injection window of the InsuPad device. Immediately afterwards the subject was asked to drink a standardized liquid meal within 10 minutes. Blood glucose measurements were taken from a peripheral venous line at a pre-determined time points. Total follow up time was 5 hours post meal.
In the daily life setting - Up to 12 months with the device (test). Subjects were asked to perform at least 3 blood glucose measurements during the day. Receives: Device: InsuPad |
| Control (without the InsuPad device) | No intervention | In the Meal Tolerance Test protocol - After overnight fast followed by a pre-study stabilization period, insulin bolus (0.2 units/kg body weight) was injected to the abdomen right before study start. Immediately afterwards the subject was asked to drink a standardized liquid meal within 10 minutes. Blood glucose measurements were taken from a peripheral venous line at a pre-determined time points. Total follow up time was 5 hours post meal. In the daily life setting - Up to 12 months without the device (control). Subjects were asked to perform at least 3 blood glucose measurements during the day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level during 120 minutes after meal start
The primary efficacy endpoint of the Meal Tolerance Test (MTT) protocol and of the daily life setting protocol was blood glucose excursion during the first 120 minutes after meal.
Measured: 0-120 minutes
Count of mild hypoglycemic events (blood glucose<75)
The primary safety endpoint was assessment of the safety of using the InsuPad device including mild hypoglycemia (blood glucose<75).
Measured: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
assessment of skin inflammation
The primary safety endpoint was assessment of the safety of using the InsuPad device including skin inflammation.
Measured: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
Count of hyperglycemia events (blood glucose>300)
The primary safety endpoint was assessment of the safety of using the InsuPad device including hyperglycemia (blood glucose>300).
Measured: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
assessment of skin irritation
The primary safety endpoint was assessment of the safety of using the InsuPad device including skin irritation.
Measured: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
Secondary outcomes (2)
post meal maximal glucose level
Secondary endpoint included: post meal maximal glucose level during 5 hours post meal.
Measured: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
area under the curve
Secondary endpoint included: area under the curve of the postprandial glucose excursion during 5 hours post meal.
Measured: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startNov 2011
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306343
- Sponsor's protocol ID
- 08-148
- Status last verified
- Nov 2014
- First submitted
- 3 Sep 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. 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 Experimental Device
- ClinicalTrials.gov ID
- NCT02306343
- Acronym / sponsor ID
- 08-148
- Conditions
- Diabetes Mellitus
- Keywords
- rapid acting insulin, insulin injection, insulin delivery, local heating, experimental device, pre and post meal glucose level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insuline Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 3 Dec 2014 (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, one-way crossover study using the Meal Tolerance Test (MTT) protocol or the daily life setting protocol.
The study consists of two parts. Subject may participate in both parts or just in one part.
The first part tests the effect of local heating on the post prandial glucose levels following a bolus at in-patient settings.Type I and type II diabetic patients on basal bolus insulin therapy admitted after overnight fast for a meal tolerance test. Subjects injected 0.2 units/kg and consumed standardized liquid meal. Blood samples for glucose and insulin measurements was taken from a venous line. The study was conducted twice with (test) and without (control) the use of the InsuPad device.
The second part evaluate the safety and efficacy of the device use at daily life settings. Type I and type II diabetic patients enrolled to the study. They will be required to perform at least 3 self monitored blood glucose (SMBG) measurements. Study length is up to 25 months. Up to one month run in period, up to 12 months with the device (test) and up to 12 months without the device (control).The subjects will be asked to record events of hypoglycemia, hyperglycemia and any adverse events related to diabetes or the study.
Detailed description
The effect of the InsuPad device was studied using the Meal Tolerance Test protocol or the daily life setting protocol. In the Meal Tolerance Test protocol subjects consumed a standardized liquid meal taken immediately after injection of insulin bolus (0.2 units/kg body weight). Each subject went through the same Meal Tolerance Test protocol twice, once with the InsuPad device (test conditions) and again without the InsuPad device (control conditions) in randomized order. The study started after an overnight fast and stabilization period in which the subject glucose level was stabilized between 100-150 mg/dl, using I.V glucose solution/oral glucose or intravenous insulin administration if needed. The patient remained stable (change of glucose level <20mg/dl) without any intervention or infusion 30 min prior to the study. Blood glucose measurements were taken from a peripheral venous at pre-specified time points. Total follow up time was 5 hours post meal. Safety limits of the study were 75 mg/dl as the low limit and 300 mg/dl as the high limit. If the subject's blood glucose level was below 75 mg/dl glucose solution was given orally to increase his blood glucose level. If subjects blood glucose was above 300 mg/dl iv insulin was given to reduce blood glucose level.
In the daily life setting protocol subjects meeting the inclusion exclusion criteria enrolled to the study. Study length was up to 25 months. Up to one month run in period, up to 12 months with the device (test) and up to 12 months without the device (control). Subjects were asked to perform at least 3 blood glucose measurements a day. Subjects were asked to fill logbooks with measured blood glucose levels and insulin doses given during the whole study. Subjects were asked to report any adverse event during the study. The subjects received a tutorial about the device usage and the study procedures. The order of the test and control phases was randomly selected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (with the InsuPad device) | Experimental | Device: InsuPadIn the Meal Tolerance Test protocol - After overnight fast followed by a pre-study stabilization period, the InsuPad device was placed on the abdomen of the subject. The InsuPad device was activated and insulin bolus (0.2 units/kg body weight) was injected right before study start. The injection was given to the subject's abdomen through the injection window of the InsuPad device. Immediately afterwards the subject was asked to drink a standardized liquid meal within 10 minutes. Blood glucose measurements were taken from a peripheral venous line at a pre-determined time points. Total follow up time was 5 hours post meal. In the daily life setting - Up to 12 months with the device (test). Subjects were asked to perform at least 3 blood glucose measurements during the day. |
| Control (without the InsuPad device) | No intervention | –In the Meal Tolerance Test protocol - After overnight fast followed by a pre-study stabilization period, insulin bolus (0.2 units/kg body weight) was injected to the abdomen right before study start. Immediately afterwards the subject was asked to drink a standardized liquid meal within 10 minutes. Blood glucose measurements were taken from a peripheral venous line at a pre-determined time points. Total follow up time was 5 hours post meal. In the daily life setting - Up to 12 months without the device (control). Subjects were asked to perform at least 3 blood glucose measurements during the day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant age above 18 (including = 18 years)
- BMI above 18kg/m2
- Insulin dependent diabetes using insulin injections
- Diabetic patients with HbA1c values below 12%
- Participant understands the study requirements and the treatment procedures ,willing to comply with all specified follow-up evaluations and provides written Informed Consent before any study-specific tests or procedures are performed
Key exclusion criteria (12 listed)
- Pregnancy
- Breast feeding women
- Alcohol addiction
- Had Coronary Artery Bypass Graft, are Post Myocardial Infarction or had active Ischemic heart failure in the last 3 months prior to the study date
- Had cardiovascular accident or 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 |
|---|---|---|
| InsuPadThe InsuPad device is composed of a disposable heating pad and a reusable control unit. The heating pad is intended for one day use. The user would attach the InsuPad device to a site where insulin can be injected. When there is a need for insulin bolus injection the user would inject the insulin to a location designate for that. The device would start heating the area around the injection site without over heating the insulin. At the end of the day the subject would remove the device, dispose of the disposable unit and put the reusable unit for recharging. | Device | Test (with the InsuPad device) |
Primary outcome
Blood glucose level during 120 minutes after meal start
Time frame: 0-120 minutes
The primary efficacy endpoint of the Meal Tolerance Test (MTT) protocol and of the daily life setting protocol was blood glucose excursion during the first 120 minutes after meal.
Count of mild hypoglycemic events (blood glucose<75)
Time frame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
The primary safety endpoint was assessment of the safety of using the InsuPad device including mild hypoglycemia (blood glucose<75).
assessment of skin inflammation
Time frame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
The primary safety endpoint was assessment of the safety of using the InsuPad device including skin inflammation.
Count of hyperglycemia events (blood glucose>300)
Time frame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
The primary safety endpoint was assessment of the safety of using the InsuPad device including hyperglycemia (blood glucose>300).
assessment of skin irritation
Time frame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
The primary safety endpoint was assessment of the safety of using the InsuPad device including skin irritation.
2 secondary outcomes
post meal maximal glucose level
Time frame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
area under the curve
Time frame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InsuPad in people with Diabetes Mellitus, run by Insuline Medical Ltd. at 1 site 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 5 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Gabriel Bitton, Ph.D. (+972-52-4800249, gabby@insuline-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose level during 120 minutes after meal start (time frame: 0-120 minutes). The study lists 5 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 3 Dec 2014.