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NCT Number: NCT00935129

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schnider children's medical center

Petah Tikva, 49202, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OmniPod system

Device

Patients will be treated with the OmniPod system for 12 weeks

Patient's conventional pump

Device

patients will be treated with their conventional pump for 12 weeks

Primary outcomes

  1. Treatment satisfaction

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

Secondary outcomes

  1. Comfort and function

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

  2. HbA1C

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

  3. Fructosamine

    Time frame: Fructosamine will be measured at baseline,12 and 24 weeks

  4. 7 points glucose profile

    Time frame: diary will be completed before every clinical visit

  5. Pump related technical difficulties

    Time frame: pump related technical difficulties will be analyzed every telephone visit

  6. continuous glucose measurements

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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2009
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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