Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the InsuPatch Device During Daily Life

NCT01114061 | Suspended

• 1 other identifier: HT4813
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes

Keywords

diabetes; postprandial glucose level; insulin pharmacodynamics; Insulin Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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

  three month with the device and three months without the device

Study Arms (1)

InsuPatch

EXPERIMENTAL

The arm with the treatment: using the insupatch device to heat the insulin infusion site.

Device: Insupatch

Interventions

Insupatch DEVICE

Applying heat to the infusion site using the insupatch device

InsuPatch

Eligibility Criteria

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

You may qualify if:

• 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.
• % ≤ HbA1c ≤ 9.5%
• 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

You may not qualify if:

• 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) .
• 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).
• Hypoglycaemia unawareness
• 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

Sponsors & Collaborators

• Insuline Medical Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: April 30, 2010
• Last Updated: September 13, 2012

Record last verified: 2011-06