Diabetics Mellitus Type 1NCT01594801
Testing the Effect of the InsuPad Device in Daily Life Conditions
A study testing InsuPad in people with Diabetics Mellitus Type 1 and Diabetes Mellitus Type 2, run by Insuline Medical Ltd. at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetics Mellitus Type 1, Diabetes Mellitus Type 2
- What is being tested?
- InsuPad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 9 sitesGermany
- Study dates
- May 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau
Aschaffenburg, 63739
Diabeteszentrum Bad Mergentheim
Bad Mergentheim
ikfe GmbH, Berlin
Berlin, 10115
GWT-TUD GmbH, Zentrum für Klinische Studien
Dresden, 01307
ikfe GmbH Mainz
Mainz, 55116
Zentrum Für Klinische Studien Neuwied
Neuwied, 56564
ikfe GmbH, Potsdam
Potsdam, 14469
Dr. Notghi Clinical Trials
Potsdam, 14471
Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben
Waldfischbach-Burgalben, 67714
About this study
Official title: Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
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.
- Being tested
- InsuPad
- Keywords
- DM, insulin, injections
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsuPadDevice
Use of the InsuPad for at least 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subject continue their routine therapy |
| Test | Experimental | Subjects using the InsuPad device Receives: Device: InsuPad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetics Mellitus Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insuline Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594801
- Sponsor's protocol ID
- CP-PP-003
- Status last verified
- Mar 2013
- First submitted
- 6 May 2012
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24392996
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
- ClinicalTrials.gov ID
- NCT01594801
- Acronym / sponsor ID
- CP-PP-003
- Keywords
- DM, insulin, injections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Insuline Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subject continue their routine therapy |
| Test | Experimental | Device: InsuPadSubjects using the InsuPad device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsuPadUse of the InsuPad for at least 3 times a day. | Device | Test |
Primary outcome
Efficacy
Time frame: 3 months
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.
Safety
Time frame: 3 months
compare the Frequency of mild hypoglycaemia events (Blood Glucose < 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 24392996Pfutzner 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.
- Related InfoLink provided by the sponsor.
Related trials for Diabetics Mellitus Type 1
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InsuPad in people with Diabetics Mellitus Type 1 and Diabetes Mellitus Type 2, run by Insuline Medical Ltd. at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.