Web-based insulin titration: Improving diabetes care in the Netherlands. A pilot study of the PANDIT® system.

Completed

Conditions: diabetes
10018424

Registration Number: NL-OMON34035

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Male or female between 18 and 80 years
* Type 2 diabetes mellitus
* Using once daily basal Insulin therapy or requiring once daily basal insulin
* Fasting glucose * 7 mmol / l on 3 consecutive measurements, no restriction on HbA1c
* BMI <45 kg/m2
* Familiarity with and access to the internet and a mobile phone
* Ability to read and understand the Dutch language
* Ability and willingness to adhere to the protocol, including daily performance of self monitored plasma glucose profiles according to the protocol
* Confirmed Written consent
* Recent (<1 year) documentation of retinopathy status

Exclusion Criteria

*Type 1 diabetes
*Non compliance with regard to daily measurement of FPG
*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 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
*History of alcohol abuse
*Night shift workers

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dosing advices given by the DN (phase 1)<br /><br>Dosing advices generated by the PANDIT system (phase 1)<br /><br>Dosing advices generated by the PANDIT system that are declined by the DN<br /><br>(phase 2)<br /><br>Episodes of hypoglycaemia </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Usability evaluation<br /><br>The amount of patients visiting the PANDIT® system at least every week<br /><br>The number of unscheduled contact moments with the DN because of medical<br /><br>questions<br /><br>The number of unscheduled contact moments with the DN because of technical<br /><br>questions<br /><br>Self monitored blood glucose values<br /><br>Used daily insulin doses<br /><br>Laboratory fasting plasma glucose<br /><br>HbA1c<br /><br>Adverse events<br /><br>Serious adverse events</p><br>