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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based insulin titration | Experimental | An online web-based insulin titration algorithm to guide patients in self-titration |
|
| Standard care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based insulin titration | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in HbA1c | Change from baseline after 13 weeks and after 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life and treatment satisfaction | Change from baseline after 13 weeks and after 26 weeks | |
| Total contact time with study staff (and the PANDIT system, if applicable) | After 26 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frits Holleman, MD PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21893723 | Result | 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. | |
| 22874288 | Result | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Proportion of subjects who reach the target of HbA1c < 7.0% |
| After 26 weeks |
| Mean change in fasting plasma glucose | 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) | After 26 weeks |
| Frequency of the usage of PANDIT among patients | After 26 weeks |
| Detection of important factors for patient compliance to internet-based self-care interventions | After 26 weeks |
| 22874403 | Result | 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. |
| D004700 | Endocrine System Diseases |