NCT01594801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

May 6, 2012

Last Update Submit

March 12, 2013

Conditions

Diabetics Mellitus Type 1Diabetes Mellitus Type 2

Keywords

DMinsulininjections

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    The primary endpoint of the study is to demonstrate the non-inferiority (margin of 0.4%) for overall glycaemic control defined as HbA1c of a treatment regimen applying InsuPad combined with an insulin dose reduction of \>10% in the test group compared to the control group not using InsuPad.

    3 months

  • Safety

    compare the Frequency of mild hypoglycaemia events (Blood Glucose \< 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.

    3 months

Study Arms (2)

Control

NO INTERVENTION

Subject continue their routine therapy

Test

EXPERIMENTAL

Subjects using the InsuPad device

Device: InsuPad

Interventions

InsuPadDEVICE

Use of the InsuPad for at least 3 times a day.

Test

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau

Aschaffenburg, 63739, Germany

Location

Diabeteszentrum Bad Mergentheim

Bad Mergentheim, Germany

Location

ikfe GmbH, Berlin

Berlin, 10115, Germany

Location

GWT-TUD GmbH, Zentrum für Klinische Studien

Dresden, 01307, Germany

Location

ikfe GmbH Mainz

Mainz, 55116, Germany

Location

Zentrum Für Klinische Studien Neuwied

Neuwied, 56564, Germany

Location

ikfe GmbH, Potsdam

Potsdam, 14469, Germany

Location

Dr. Notghi Clinical Trials

Potsdam, 14471, Germany

Location

Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben

Waldfischbach-Burgalben, 67714, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24392996DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Design

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

Study Record Dates

First Submitted

May 6, 2012

First Posted

May 9, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

DE(9)