Clinical trial NCT01594801: Testing the Effect of the InsuPad Device in Daily Life Conditions
Official title: Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetics Mellitus Type 1
Diabetes Mellitus Type 2
Keywords: DM
insulin
injections
Lead sponsor: Insuline Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the test protocol for the InsuPad device. The aim of the study is to show economical benefit when using the InsuPad device, by testing the effect of the InsuPad device on reducing injected insulin dose while keeping the same overall glycaemic control.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 75 years (including 18 and 75 years old).
* Type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of \> 60 IU/day.
* HbA1c \>=6.0% and =\< 8%
* Use of short-acting prandial insulin analogues with multiple daily injections. The analog insulin brands to be used will be either insulin Lispro (Humalog, Liprolog) or insulin Aspart (NovoRapid) or insulin Glulisin (Apidra).
* Subject agrees to sign consent form before any study-specific tests or procedures are to be performed.
* Study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book.

Exclusion Criteria:

* Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
* Known gastro- or enteroparesis.
* Unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start.
* Severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
* Hypoglycaemia unawareness (Score \> 4 in the Hypoglycaemia Awareness Questionnaire)
* Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
* Any known life-threatening disease
* Pregnant women, lactating women or women who intend to become pregnant during the observation period
* Any other condition or compliance issues that might interfere with study participation or results
* Subjects with heat sensitivity
* Subjects involved in or planned to participate in other studies
* Subjects who are incapable of contracting or under guardianship

Primary outcomes:
measure: Efficacy
timeFrame: 3 months
measure: Safety
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau
city: Bad Mergentheim
country: Germany
facility: Diabeteszentrum Bad Mergentheim
city: Berlin
country: Germany
facility: ikfe GmbH, Berlin
city: Dresden
country: Germany
facility: GWT-TUD GmbH, Zentrum für Klinische Studien
city: Mainz
country: Germany
facility: ikfe GmbH Mainz
city: Neuwied
country: Germany
facility: Zentrum Für Klinische Studien Neuwied
city: Potsdam
country: Germany
facility: ikfe GmbH, Potsdam
city: Potsdam
country: Germany
facility: Dr. Notghi Clinical Trials
city: Waldfischbach-Burgalben
country: Germany
facility: Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben
Study officials:
References:
citation: Pfutzner A, Hermanns N, Funke K, Forst T, Behnke T, Bitton G, Nagar R, Raz I, Haak T. The Barmer study: impact of standardized warming of the injection site to enhance insulin absorption and reduce prandial insulin requirements and hypoglycemia in obese patients with diabetes mellitus. Curr Med Res Opin. 2014 May;30(5):753-60. doi: 10.1185/03007995.2014.880049. Epub 2014 Jan 17.