Web-based Insulin Titration - An Efficacy Study

Study Overview
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Brief Summary
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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.

Official Title
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Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Web-based insulin titration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based insulin titration<br>An online web-based insulin titration algorithm to guide patients in self-titration | Device: Web-based insulin titration<br> <br> * Other names: PANDIT;|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in HbA1c |  | Change from baseline after 13 weeks and after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of subjects who reach the target of HbA1c < 7.0% |  | After 26 weeks | 
| Mean change in fasting plasma glucose |  | Change from baseline after 13 weeks and after 26 weeks | 
| Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia) |  | After 26 weeks | 
| Frequency of the usage of PANDIT among patients |  | After 26 weeks | 
| Detection of important factors for patient compliance to internet-based self-care interventions |  | After 26 weeks |