Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device
NCT ID: NCT02306343
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2011-11-30
2015-09-30
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Test (with the InsuPad device)
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.
InsuPad
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.
Control (without the InsuPad device)
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.
No interventions assigned to this group
Interventions
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InsuPad
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Insuline Medical Ltd.
INDUSTRY
Responsible Party
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Locations
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InsuLine Medical
Petah Tikva, , Israel
Countries
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Central Contacts
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Other Identifiers
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08-148
Identifier Type: -
Identifier Source: org_study_id