- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715090
Web-based Insulin Titration - An Efficacy Study
November 19, 2014 updated by: F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amsterdam, Netherlands
- Academic Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
|
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Experimental: Web-based insulin titration
An online web-based insulin titration algorithm to guide patients in self-titration
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in HbA1c
Time Frame: Change from baseline after 13 weeks and after 26 weeks
|
Change from baseline after 13 weeks and after 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life and treatment satisfaction
Time Frame: Change from baseline after 13 weeks and after 26 weeks
|
Change from baseline after 13 weeks and after 26 weeks
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Total contact time with study staff (and the PANDIT system, if applicable)
Time Frame: After 26 weeks
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After 26 weeks
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Proportion of subjects who reach the target of HbA1c < 7.0%
Time Frame: After 26 weeks
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After 26 weeks
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Mean change in fasting plasma glucose
Time Frame: Change from baseline after 13 weeks and after 26 weeks
|
Change from baseline after 13 weeks and after 26 weeks
|
Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)
Time Frame: After 26 weeks
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After 26 weeks
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Frequency of the usage of PANDIT among patients
Time Frame: After 26 weeks
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After 26 weeks
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Detection of important factors for patient compliance to internet-based self-care interventions
Time Frame: After 26 weeks
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After 26 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frits Holleman, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
October 25, 2012
First Posted (Estimate)
October 26, 2012
Study Record Updates
Last Update Posted (Estimate)
November 20, 2014
Last Update Submitted That Met QC Criteria
November 19, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 40248.018.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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