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

Clalit Health Services

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Patient's conventional pump; Device: OmniPod system

Study type: Interventional

Funder types: Other

Identifiers

NCT00935129

rmc005431ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

OmniPod system

Experimental group

Description:

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

Treatment:

Device: OmniPod system

patient's conventional pump

Active Comparator group

Description:

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

Treatment:

Device: Patient's conventional pump