Web-based Insulin Titration - An Efficacy Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715090
• Other study ID #: NL 40248.018.12
• Status: Completed
• Phase: N/A
• First received: October 22, 2012
• Last updated: November 19, 2014
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Web-based insulin titration

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Gude WT, Simon AC, Peute LW, Holleman F, Hoekstra JB, Peek N, Jaspers MW. Formative usability evaluation of a web-based insulin self-titration system: preliminary results. Stud Health Technol Inform. 2012;180:1209-11. — View Citation

Simon AC, Holleman F, Gude WT, Hoekstra JB, Peek N. Safety of a web-based insulin titration system for patients with type 2 diabetes mellitus - pilot study. Stud Health Technol Inform. 2012;180:731-5. — View Citation

Simon AC, Holleman F, Hoekstra JB, De Clercq PA, Lemkes BA, Hermanides J, Peek N. Development of a web-based decision support system for insulin self-titration. Stud Health Technol Inform. 2011;169:103-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c		Change from baseline after 13 weeks and after 26 weeks	No
Secondary	Quality of life and treatment satisfaction		Change from baseline after 13 weeks and after 26 weeks	No
Secondary	Total contact time with study staff (and the PANDIT system, if applicable)		After 26 weeks	No
Secondary	Proportion of subjects who reach the target of HbA1c < 7.0%		After 26 weeks	No
Secondary	Mean change in fasting plasma glucose		Change from baseline after 13 weeks and after 26 weeks	No
Secondary	Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)		After 26 weeks	Yes
Secondary	Frequency of the usage of PANDIT among patients		After 26 weeks	No
Secondary	Detection of important factors for patient compliance to internet-based self-care interventions		After 26 weeks	No