Evaluation of the Accu-Chek® Combo System by subjects treated with CSII (Continuous Subcutaneous Insulin Infusion).

Phase 2

Completed

Conditions: diabetes
Diabetes Mellitus
10018424

Registration Number: NL-OMON33856

Lead Sponsor: Disetronic Medical System AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

• Subjects must be 18 years or older at the time of the screening visit
• Subjects must have an HbA1c <=10% (taken less than 3 months before the screening visit)
• Subjects must be willing to perform self management of blood glucose (SMBG) at least 4 times per day
• Willing to perform episodic monitoring prior to study visits (3 days x 7 BG-tests)
• Subjects must currently be using an insulin pump for at least 6 months prior to the
screening visit
• Subjects are willing to use the bolus calculator and remote control features of the system
• Subjects should be willing to adhere to the study visit schedule

Exclusion Criteria

• Subjects who used systemic oral or inhaled steroids for > 14 days within the last 3 months
• Subjects on Chemotherapy or Radiation therapy (self-reported)
• Subjects currently addicted to alcohol or substances of abuse as determined by the investigator
• Subjects planning to relocate or travel extensively (for periods of more than 2 weeks during phase I of the study
• Subjects with psychological issues which would impair ability to consent or participate (at the Physicians* discretion)
• Subjects show have had severe hypoglycemia requiring 3rd party assistance within the last 4 weeks
• Subjects who are either pregnant or lactating or are currently planning a pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>End point data for this study will be obtained from the following sources:<br /><br>1: From pump downloads:<br /><br>2: From meter downloads:<br /><br>3: From Diary<br /><br>4 :From Questionnaires</p><br>

Secondary Outcome Measures