Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes

May 6, 2012 updated by: Rabin Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Randomized, two arms, open, crossover 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.

Study will consist of 4 clinic visits taking place at -2,0,12 and 24 weeks and additional 4 telephone visits taking place at 4,8,16 and 20 weeks. In addition, patients will be invited one week prior to visit 5 and visit 8 in order to insert a continuous glucose sensor. Patients will complete DTSQ and Comfort & Function questionnaires at weeks 0, 12 and 24, before and at the end of each study arm.

On each clinical visits the following parameters will be evaluated: vital signs, HbA1c, 4 and 7 points glucose profile, hypoglycemia events, hyperglycemia events and pump related technical problems.

The telephone visits will include pump related technical problems solving and AE/SAE reporting.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel, 49202
        • Schnider Children's medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Patients participating in other device or drug studies
  3. Clinical diagnosis of hypoglycaemic unawareness
  4. Known dermal hypersensitivity to products that contain medical adhesive
  5. Taking prescription medications that could complicate the management of glycemic control.
  6. Inability to understand/complete the Treatment satisfaction questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OmniPod system
At this arm patients will be treated with the OmniPod system for 12 weeks
Device: OmniPod system
Patients will be treated with the OmniPod system for 12 weeks
ACTIVE_COMPARATOR: patient's conventional pump
At this arm patients will be treated with their conventional pump for 12 weeks
Device: Patient's conventional pump
patients will be treated with their conventional pump for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment satisfaction
Time Frame: Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks
Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Comfort and function
Time Frame: Comfort and function questionnaires will be completed at weeks 0,12 and 24.
Comfort and function questionnaires will be completed at weeks 0,12 and 24.
HbA1C
Time Frame: HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks
HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks
Fructosamine
Time Frame: Fructosamine will be measured at baseline,12 and 24 weeks
Fructosamine will be measured at baseline,12 and 24 weeks
7 points glucose profile
Time Frame: diary will be completed before every clinical visit
diary will be completed before every clinical visit
Pump related technical difficulties
Time Frame: pump related technical difficulties will be analyzed every telephone visit
pump related technical difficulties will be analyzed every telephone visit
continuous glucose measurements
Time Frame: continuous glucose sensor will be inserted one week before visits 5 and 8
continuous glucose sensor will be inserted one week before visits 5 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Moshe Phillip, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (ESTIMATE)

July 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc005431ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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