Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device

NCT02306343 | Unknown

• 1 other identifier: 08-148
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

rapid acting insulin; insulin injection; insulin delivery; local heating; experimental device; pre and post meal glucose level

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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).

  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.

  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

  5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol

• area under the curve

  5 hours in the Meal Tolerance Test (MTT) protocol and up to 24 months during the daily life setting protocol

Study Arms (2)

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.

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.

Interventions

InsuPad DEVICE

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.

Test (with the InsuPad device)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insuline Medical Ltd.: lead

Study Sites (1)

InsuLine Medical

Petah Tikva, 4900202, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Gabriel Bitton, Ph.D.

CONTACT

+972-52-4800249; gabby@insuline-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: December 3, 2014
• Study Start: November 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 3, 2014

Record last verified: 2014-11

Locations

IL (1)