NCT01216618

Brief Summary

The study is a prospective, multi-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_3

Geographic Reach
2 countries

3 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

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 4, 2014

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

October 5, 2010

Last Update Submit

September 3, 2014

Conditions

Diabetes Mellitus, Insulin-Dependent

Keywords

MiniMed paradigm insulin pumpsinsulin LisproInsulin Asprt.

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.

    Up to 5 hours

  • Safety

    frequency and severity of all treatment-related adverse events until the completion of the study.

    Up to one month

Secondary Outcomes (2)

  • pharmacokinetics

    Up to 5 hours

  • Pharmacodynamic

    Up to 5 hours

Study Arms (2)

Device

EXPERIMENTAL

Subject starts with two clamps including device use follows by a clamp without device use

Device: InsuPatch

Control

NO INTERVENTION

Subject starts with clamps without device

Interventions

InsuPatchDEVICE

the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.

Device

Eligibility Criteria

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

You may qualify if:

  • Age between 18- 65 years old (including = 18 years and =65 years)
  • Gender: men and women
  • BMI: 18-35 kg/m2
  • Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
  • Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
  • Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
  • Subject is willing to comply with all specified follow-up evaluations -

You may not qualify if:

  • Pregnancy
  • Breast feeding women.
  • Alcohol addiction
  • Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
  • Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
  • Suffer from uncontrolled Hypertension (blood pressure in mm HG \>160 systolic or \> 95 diastolic)
  • Low blood hemoglobin concentration \<9 g/dL for female and \<11g/dL for male.
  • Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
  • Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH\>5.5 mIU/L or TSH\<0.4 mIU/L
  • Psychological incompetence
  • Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
  • Subjects with diminished skin integrity
  • Subjects with heat sensitivity
  • Subjects involved in or planed to participate in other studies
  • Subjects using other drugs therapies to control blood glucose level other than insulin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mills-Peninsula Health Services

San Mateo, California, 94401, United States

Location

Wolfson Medical Center

Holon, Israel

Location

Haddasah Medical Organization

Jerusalem, Israel

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 7, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 4, 2014

Record last verified: 2011-06

Locations

US(1)IL(2)