Clinical trial NCT01715090: Web-based Insulin Titration - An Efficacy Study
Official title: Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in HbA1c
timeFrame: Change from baseline after 13 weeks and after 26 weeks
Secondary outcomes:
measure: Quality of life and treatment satisfaction
timeFrame: Change from baseline after 13 weeks and after 26 weeks
measure: Total contact time with study staff (and the PANDIT system, if applicable)
timeFrame: After 26 weeks
measure: Proportion of subjects who reach the target of HbA1c < 7.0%
timeFrame: After 26 weeks
measure: Mean change in fasting plasma glucose
timeFrame: Change from baseline after 13 weeks and after 26 weeks
measure: Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)
timeFrame: After 26 weeks
measure: Frequency of the usage of PANDIT among patients
timeFrame: After 26 weeks
measure: Detection of important factors for patient compliance to internet-based self-care interventions
timeFrame: After 26 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Frits Holleman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.