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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

OmniPod system

Patient's conventional pump

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Treatment satisfaction, OmniPod, Insulin pump, diabetes

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Schnider children's medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OmniPod system

patient's conventional pump

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment satisfaction

Secondary Outcome Measures

Comfort and function

HbA1C

Fructosamine

7 points glucose profile

Pump related technical difficulties

continuous glucose measurements

Full Information

NCT ID

NCT00935129

First Posted

July 6, 2009

Last Updated

May 6, 2012

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00935129

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Treatment satisfaction, OmniPod, Insulin pump, diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OmniPod system

Arm Type

Experimental

Arm Description

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

Arm Title

patient's conventional pump

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

OmniPod system

Intervention Description

Patients will be treated with the OmniPod system for 12 weeks

Intervention Type

Device

Intervention Name(s)

Patient's conventional pump

Intervention Description

patients will be treated with their conventional pump for 12 weeks

Primary Outcome Measure Information:

Title

Treatment satisfaction

Time Frame

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

Secondary Outcome Measure Information:

Title

Comfort and function

Time Frame

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

Title

HbA1C

Time Frame

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

Title

Fructosamine

Time Frame

Fructosamine will be measured at baseline,12 and 24 weeks

Title

7 points glucose profile

Time Frame

diary will be completed before every clinical visit

Title

Pump related technical difficulties

Time Frame

pump related technical difficulties will be analyzed every telephone visit

Title

continuous glucose measurements

Time Frame

continuous glucose sensor will be inserted one week before visits 5 and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshe Phillip

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schnider children's medical center

City

Petach-Tikva

ZIP/Postal Code

49202

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

22283640

Citation

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.

Results Reference

derived

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

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