Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2012-12-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Web-based insulin titration
An online web-based insulin titration algorithm to guide patients in self-titration
Web-based insulin titration
Standard care
No interventions assigned to this group
Interventions
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Web-based insulin titration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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F Holleman
MD PhD
Principal Investigators
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Frits Holleman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academic Medical Center
Amsterdam, , Netherlands
Countries
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References
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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.
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.
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.
Other Identifiers
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NL 40248.018.12
Identifier Type: -
Identifier Source: org_study_id