PDM-ProValue study programm


Integrated Personalised Diabetes Management markedly improves therapy outcomes: First results from the PDM-ProValue study program

> PDM-ProValue study program
> Structured and recurring cycle of diabetes management improves outcomes


PDM-ProValue study program

  • The results of the PDM-ProValue study program demonstrate that integrated Personalised Diabetes Management (iPDM) can significantly reduce HbA1c levels and improve glycemic control.
  • The study findings reveal additional benefits of the iPDM concept and how it can contribute to an optimised diabetes therapy by a profound increase in the number of therapeutic adaptations at an earlier stage.
  • Structured guidance for physicians and people with diabetes combined with a low-threshold digital solution like Accu-Chek SmartPix suggest to represent diagnostic and therapeutic measures which significantly contribute to the observed improved glycemic control.

The PDM-ProValue study program was conducted with more than 900 patients treated in diabetes specialist and general medical practices in Germany. The results of this prospective, controlled and cluster-randomised study are of high relevance for both healthcare professionals and people with diabetes: ”For the first time there is scientific evidence that using iPDM enhances everyday therapy management. Supported by innovative digital solutions the therapy outcomes of people with insulin-treated type 2 diabetes can be improved and we can overcome clinical inertia, probably one of the major hurdles to reaching more time in range”, explains Prof. Lutz Heinemann, Germany. Experts still see clinical inertia as a main cause hindering people with diabetes from reaching their therapy goals despite optimal access to medication and devices. Hence, a concept like iPDM, which has shown to successfully improve glycemic control, is highly relevant to physicians, people with diabetes and healthcare systems.


Structured and recurring cycle of diabetes management improves outcomes

The study sites were randomised in an iPDM intervention arm and a control (CNL) arm. Patients at the CNL sites received standard therapy whereas patients at the iPDM intervention sites followed the structured six-step personalised diabetes management approach. The process – based on demand-oriented patient education, initiation of structured self-monitoring of blood glucose (SMBG) including 7-point profiles, electronic documentation as well as software-supported analysis and visualisation of the collected SMBG data followed by an interpretation of these pre-processed data – represents an integrated solution that not only created a better understanding of the patients’ glycemic situation but also supported healthcare professionals and people with diabetes in their therapeutic decision making.

The efficacy of the iPDM concept was clearly shown: HbA1c was lowered significantly by 0.5% in the iPDM group over the 12-months study duration (p<0.0001). This reduction in HbA1c is comparable to medical therapy and was significantly more pronounced than in the CNL group (0.3%, p<0.0001). Despite marked HbA1c reduction the incidence of hypoglycemic episodes (blood glucose level <70 mg/dl) also remained nearly unchanged over time. The iPDM concept was well accepted by both people with diabetes and their physicians. Moreover, these results underline the contribution that iPDM can bring to overcoming clinical inertia: doctors in the iPDM group made considerably more and earlier therapy adjustments, compared to the CNL group. Prof Heinemann concluded: “I am excited to see these results of the PDM-ProValue study program as they emphasize the considerable potential of the iPDM approach and suggest to not only minimise clinical inertia and improve overall glycemic control but at the same time can contribute to achieving more time in range.”

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