The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device

A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases

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".

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus With Diabetic Neuralgia
• Intervention / Treatment: Device: InsuPad

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Bad Mergentheim, Germany
    • Bad Mergentheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InsuPad Device; Use of the InsuPad which heats the injection site.	Device: InsuPad; Heating pad
No Intervention: CONTROL; no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy	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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Mean change in post prandial glucose level at 90 minutes during the outpatient phase.	8 weeks
Efficacy	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.	8 weeks
Safety	• Number and severity of hypoglycaemias and hyperglycaemias and assessment of relationship to the use of the InsuPad device during the whole study.	14 weeks
Satisfaction	• Patient satisfaction (subjective clinical performance) at the end of the study	14 weeks

Collaborators and Investigators

• Sponsor: Insuline Medical Ltd.
• Collaborators: Forschungsinstitut der Diabetes Akademie Mergentheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: insulin injection
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus, Type 1; Neuralgia; Diabetic Neuropathies
• Other Study ID Numbers: CP-PP-002