The InsuPad in Daily Life Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forschungsinstitut der Diabetes Akademie Mergentheim
Information provided by (Responsible Party):
Insuline Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01352767
First received: May 11, 2011
Last updated: March 12, 2013
Last verified: May 2012
  Purpose

A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test".


Condition Intervention Phase
Type 1 Diabetes Mellitus With Diabetic Neuralgia
Device: InsuPad
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases

Resource links provided by NLM:


Further study details as provided by Insuline Medical Ltd.:

Primary Outcome Measures:
  • efficacy [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    AUC120 BG (area under the curve of postprandial glucose change 2 hours after meal) after breakfast and dinner under standardized conditions during the inpatient phase.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Mean change in post prandial glucose level at 90 minutes during the outpatient phase.

  • Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    AUC60 Ins (area under the curve of insulin concentration change 1 hour after meal) after breakfast and dinner under standardized conditions during the inpatient phase.

  • Safety [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    • Number and severity of hypoglycaemias and hyperglycaemias and assessment of relationship to the use of the InsuPad device during the whole study.

  • Satisfaction [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    • Patient satisfaction (subjective clinical performance) at the end of the study


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: InsuPad Device
Use of the InsuPad which heats the injection site.
Device: InsuPad
Heating pad
No Intervention: CONTROL
no treatment

Detailed Description:

A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test". Each subject will be randomly selected into one of two groups, group "A" and group "B". Forty (40) type I subjects who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

During the inpatient phase subjects will have standardized breakfast and dinner and venous blood samples will be taken for insulin and blood glucose measurements. Comparison of the two days ("control" and "test") will enable us to evaluate the effect of the device on post prandial glucose levels and insulin levels.

During the outpatient (daily life) phase subjects will be required to perform at least 5 self blood glucose measurements (SMBG), three before each meal and two at 90 minutes post breakfast and dinner. Comparing the SMBG measurement from the two periods will enable us to evaluate the effect of the device on post prandial glucose levels. The subjects will be contacted over the phone by the study staff to verify compliance with the protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged 18 to 70 years (values included)
  • Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ≥ 0.7 units per kg bodyweight.
  • 6% ≤ HbA1c ≤ 9.5%
  • Use of short-acting prandial insulin analogues with injections
  • Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book.
  • Willing to sign informed consent

Exclusion Criteria:

  • Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
  • Known gastro- or enteroparesis.
  • Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start.
  • Severe hypoglycemic 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, see appendix)
  • 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 planed to participate in other studies
  • Subjects who are incapable of contracting or under guardianship
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352767

Locations
Germany
Bad Mergentheim
Bad Mergentheim, Germany
Sponsors and Collaborators
Insuline Medical Ltd.
Forschungsinstitut der Diabetes Akademie Mergentheim
  More Information

Additional Information:
No publications provided

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT01352767     History of Changes
Other Study ID Numbers: CP-PP-02
Study First Received: May 11, 2011
Last Updated: March 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Insuline Medical Ltd.:
insulin injection

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Neuralgia
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications

ClinicalTrials.gov processed this record on April 15, 2014