Web-based Insulin Titration - An Efficacy Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01715090

Enrollment

Registered

2012-10-26

Start date

2012-12-31

Completion date

2014-07-31

Last updated

2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DEVICEWeb-based insulin titration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean change in HbA1c	Change from baseline after 13 weeks and after 26 weeks

Secondary

Measure	Time frame
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
Quality of life and treatment satisfaction	Change from baseline after 13 weeks and 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
Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)	After 26 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026