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Completed

NCT Number: NCT01715090

Web-based Insulin Titration - An Efficacy Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based insulin titration

Device

Other names: PANDIT

Primary outcomes

  1. Mean change in HbA1c

    Time frame: Change from baseline after 13 weeks and after 26 weeks

Secondary outcomes

  1. Quality of life and treatment satisfaction

    Time frame: Change from baseline after 13 weeks and after 26 weeks

  2. Total contact time with study staff (and the PANDIT system, if applicable)

    Time frame: After 26 weeks

  3. Proportion of subjects who reach the target of HbA1c < 7.0%

    Time frame: After 26 weeks

  4. Mean change in fasting plasma glucose

    Time frame: Change from baseline after 13 weeks and after 26 weeks

  5. Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)

    Time frame: After 26 weeks

  6. Frequency of the usage of PANDIT among patients

    Time frame: After 26 weeks

  7. Detection of important factors for patient compliance to internet-based self-care interventions

    Time frame: After 26 weeks

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2012
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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