Web-based insulin titration: Improving diabetes care in the Netherlands. An efficacy study.

Completed

Conditions: 10018424
diabetes

Registration Number: NL-OMON39501

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

•Male or female between 18 and 80 years
•Type 2 diabetes mellitus (diagnosed clinically) for >= 6 months
•HbA1c >7.5%
•Once daily basal insulin therapy usage of <= 1 year or having an indication for basal insulin therapy
•Fasting glucose values >= 7 mmol/L on three consecutive measurements
•BMI < 40 kg/m2
•Ability to read and understand the Dutch language
•Familiarity with the Internet and use of a mobile phone
•Ability and willingness to adhere to the protocol including daily performance of self monitored plasma glucose (SMPG) profiles according to the protocol
•Ability and willingness to use a web-based insulin self-titration system
•Confirmed written consent

Exclusion Criteria

•Type 1 diabetes
•Recurrent severe hypoglycaemia or hypoglycaemic unawareness
•Active proliferative diabetic retinopathy
•Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator*s opinion could interfere with the results of the trial
•Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>•To measure the mean changes in HbA1c from baseline to end point in the PANDIT<br /><br>group as compared to the control group. A difference of 0.5% after 26 weeks of<br /><br>follow-up in the PANDIT group as compared to the control group will be<br /><br>considered effective. HbA1c will be measured at baseline, after 13 weeks and<br /><br>after 26 weeks of treatment.</p><br>

Secondary Outcome Measures