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

NCT01352767 | Completed Phase 4

• 1 other identifier: CP-PP-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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".

Conditions

Type 1 Diabetes Mellitus With Diabetic Neuralgia

Keywords

insulin injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Efficacy

  8 weeks

• Efficacy

  8 weeks

• Safety

  14 weeks

• Satisfaction

  14 weeks

Study Arms (2)

InsuPad Device

EXPERIMENTAL

Use of the InsuPad which heats the injection site.

Device: InsuPad

CONTROL

NO INTERVENTION

no treatment

Interventions

InsuPad DEVICE

Heating pad

InsuPad Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insuline Medical Ltd.: lead
• Forschungsinstitut der Diabetes Akademie Mergentheim: collaborator

Study Sites (1)

Bad Mergentheim

Bad Mergentheim, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 5, 2014

Record last verified: 2012-05

Locations

DE (1)