Web-based Insulin Titration - An Efficacy Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Web-based insulin titration

• Registration Number: NCT01715090
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The main objective of the study is to determine whether an intensive web-based titration system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective in improving glycaemic control in patients with diabetes mellitus type 2 using a basal insulin, compared to standard care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Study Start: 2012-12
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Male or female between 18 and 80 years
• Type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
• Once daily basal insulin therapy usage
• No restriction on HbA1c or FPG
• 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
• Ability and willingness to use a web-based insulin self-titration system
• Confirmed written consent

Exclusion Criteria

• Type 1 diabetes
• Use of systemic corticosteroid in the last three months
• Recurrent severe hypoglycaemia or hypoglycaemic unawareness
• Active proliferative diabetic retinopathy
• Any clinically significant disease or disorder
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• Working in night shifts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based insulin titration	Web-based insulin titration	An online web-based insulin titration algorithm to guide patients in self-titration

Primary Outcome Measures

Name	Time	Method
Mean change in HbA1c	Change from baseline after 13 weeks and after 26 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who reach the target of HbA1c < 7.0%	After 26 weeks
Quality of life and treatment satisfaction	Change from baseline after 13 weeks and after 26 weeks
Total contact time with study staff (and the PANDIT system, if applicable)	After 26 weeks
Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)	After 26 weeks
Detection of important factors for patient compliance to internet-based self-care interventions	After 26 weeks
Mean change in fasting plasma glucose	Change from baseline after 13 weeks and after 26 weeks
Frequency of the usage of PANDIT among patients	After 26 weeks

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands