4. iPDM at Work: The PDM Pro Value Study Program
The results of the PDM ProValue study program demonstrate that the use of iPDM is beneficial for patients and their physicians[9].
The PDM ProValue study program was performed in order to test the ability of iPDM to improve outcomes for people with diabetes. It was a prospective, cluster randomized, controlled trial that took place over 12 months. It included 907 patients with insulin-treated type 2 diabetes who were enrolled and eligible for analysis from 101 study sites in Germany. During those 12 months, the patients had six visits with their doctors at the time intervals shown in the figure. Several aspects of the iPDM process were performed at each one of these visits.
Electronic tools were used in the PDM-ProValue study program
- Automated analysis and evaluation of blood glucose data in the form of various reports and assessments
- Personalisation with support from low-threshold digital solutions for visualisation and data analysis
The primary endpoint
was improvement in glycaemic control (HbA1c reduction) after 12 months vs. usual care.
Secondary endpoints
included diabetes therapy adjustments, blood glucose testing frequency, patient reported outcomes, physician reported outcomes and process optimization.
The following graphics show key results of the PDM ProValue study program
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In the pooled analysis of the PDM ProValue study program, the iPDM intervention resulted in a significant 0.5% reduction in HbA1c levels compared to baseline and a 0.2% reduction compared to the usual care group that was also significant.
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Importantly, no increase in the number of hypoglycaemic events was observed between the groups.
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More non-medical, life-style physician recommendations (e.g. physical activity, nutrition counselling) were seen in the iPDM group.
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Also, significantly more patients in the iPDM group were requested to change their current diabetes medication (insulin and non-insulin).
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In this respect, significantly more patients in the iPDM group were requested to adjust their basal insulin early in the study course.
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There was also a clear trend that more iPDM patients were asked to adjust their prandial insulin, reaching significance at month 12.
7
Importantly, patients in the iPDM group stated a higher change in diabetes treatment satisfaction.
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Physicians in the iPDM group also reported better adherence than before study start.
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Physicians were more satisfied with the iPDM process: their overall rating of the current diabetes therapy was higher; the outcome of the current diabetes therapy was perceived to be better; and the effort and benefit of the current diabetes therapy was perceived to be higher.
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Finally, physicians also stated improved satisfaction regarding: the analysis of blood glucose data; the use of blood glucose data for therapy decisions; and the communication with the patient.
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The results of the PDM ProValue study program demonstrate
that the use of an integrated, structured and personalized approach in the evaluation of diagnostic data and therapeutic decision-making provides tangible benefits for patients with insulin-treated type 2 diabetes and their physicians. iPDM represents an easy-to-implement approach with an integrated software solution. For the diabetes team, iPDM helps improve the quality and effectiveness of their communication with such patients. It is compatible with novel diagnostic tools, e.g. continuous glucose monitoring, and can be enhanced further as new assessment tools emerge and become available.
[9] Kulzer et al. Integrated personalized diabetes management improves glycemic control in patients with insulin-treated type 2 diabetes: Results of the PDM-ProValue study program. Diabetes Res Clin Pract. 2018; 144: 200–12.
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