NCT00935129

Brief Summary

Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes. The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 8, 2012

Status Verified

February 1, 2011

Enrollment Period

1.5 years

First QC Date

July 6, 2009

Last Update Submit

May 6, 2012

Conditions

Type 1 Diabetes

Keywords

Treatment satisfactionOmniPodInsulin pumpdiabetes

Outcome Measures

Primary Outcomes (1)

  • Treatment satisfaction

    Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks

Secondary Outcomes (6)

  • Comfort and function

    Comfort and function questionnaires will be completed at weeks 0,12 and 24.

  • HbA1C

    HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks

  • Fructosamine

    Fructosamine will be measured at baseline,12 and 24 weeks

  • 7 points glucose profile

    diary will be completed before every clinical visit

  • Pump related technical difficulties

    pump related technical difficulties will be analyzed every telephone visit

  • +1 more secondary outcomes

Study Arms (2)

OmniPod system

EXPERIMENTAL

At this arm patients will be treated with the OmniPod system for 12 weeks

Device: OmniPod system

patient's conventional pump

ACTIVE COMPARATOR

At this arm patients will be treated with their conventional pump for 12 weeks

Device: Patient's conventional pump

Interventions

OmniPod systemDEVICE

Patients will be treated with the OmniPod system for 12 weeks

OmniPod system
Patient's conventional pumpDEVICE

patients will be treated with their conventional pump for 12 weeks

patient's conventional pump

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 diabetes diagnosed at least 1 year prior to study entry
  • Use of continuous subcutaneous insulin infusion therapy for at least one year
  • Age: 18-35 years old
  • HbA1c \>8.0
  • At least 4 self blood glucose measurements per day
  • No more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month
  • Capable of reading pump screen in English
  • Able to understand and sign subject informed consent forms

You may not qualify if:

  • Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
  • Patients participating in other device or drug studies
  • Clinical diagnosis of hypoglycaemic unawareness
  • Known dermal hypersensitivity to products that contain medical adhesive
  • Taking prescription medications that could complicate the management of glycemic control.
  • Inability to understand/complete the Treatment satisfaction questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schnider children's medical center

Petah Tikva, 49202, Israel

Location

Related Publications (1)

  • Lebenthal Y, Lazar L, Benzaquen H, Shalitin S, Phillip M. Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. Diabetes Technol Ther. 2012 May;14(5):411-7. doi: 10.1089/dia.2011.0228. Epub 2012 Jan 27.

    PMID: 22283640DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Moshe Phillip

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 8, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 8, 2012

Record last verified: 2011-02

Locations

IL(1)