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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935129
• Other study ID #: rmc005431ctil
• Status: Completed
• Phase: N/A
• First received: July 6, 2009
• Last updated: May 6, 2012
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• OmniPod system
Patients will be treated with the OmniPod system for 12 weeks
• Patient's conventional pump
patients will be treated with their conventional pump for 12 weeks

Locations

Country	Name	City	State
Israel	Schnider children's medical center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment satisfaction		Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks	No
Secondary	Comfort and function		Comfort and function questionnaires will be completed at weeks 0,12 and 24.	No
Secondary	HbA1C		HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks	No
Secondary	Fructosamine		Fructosamine will be measured at baseline,12 and 24 weeks	No
Secondary	7 points glucose profile		diary will be completed before every clinical visit	No
Secondary	Pump related technical difficulties		pump related technical difficulties will be analyzed every telephone visit	No
Secondary	continuous glucose measurements		continuous glucose sensor will be inserted one week before visits 5 and 8	No