Clinical trial NCT00935129: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Treatment satisfaction
OmniPod
Insulin pump
diabetes
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment satisfaction
timeFrame: Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks
Secondary outcomes:
measure: Comfort and function
timeFrame: Comfort and function questionnaires will be completed at weeks 0,12 and 24.
measure: HbA1C
timeFrame: HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks
measure: Fructosamine
timeFrame: Fructosamine will be measured at baseline,12 and 24 weeks
measure: 7 points glucose profile
timeFrame: diary will be completed before every clinical visit
measure: Pump related technical difficulties
timeFrame: pump related technical difficulties will be analyzed every telephone visit
measure: continuous glucose measurements
timeFrame: continuous glucose sensor will be inserted one week before visits 5 and 8
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schnider children's medical center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip
role: PRINCIPAL_INVESTIGATOR
References:
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.