Clinical trial NCT02306343: Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device
Official title: Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: rapid acting insulin
insulin injection
insulin delivery
local heating
experimental device
pre and post meal glucose level
Lead sponsor: Insuline Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
measure: Blood glucose level during 120 minutes after meal start
timeFrame: 0-120 minutes
measure: Count of mild hypoglycemic events (blood glucose<75)
timeFrame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
measure: assessment of skin inflammation
timeFrame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
measure: Count of hyperglycemia events (blood glucose>300)
timeFrame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
measure: assessment of skin irritation
timeFrame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
Secondary outcomes:
measure: post meal maximal glucose level
timeFrame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
measure: area under the curve
timeFrame: 5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: InsuLine Medical
Study officials:
References: