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Table 1 Crucial aspects to consider in clinical studies with medical devices that rely on behavioral changes and options to reduce potential limitations including their challenges

From: Diabetes management intervention studies: lessons learned from two studies

Aspects to consider

Options to reduce limitations


Engaging participants in the intervention group

Optimal engagement of involved HCPs:

 • Investigator meetings

 • Repeated training sessions of study sites

 • Peer-to-peer review

• Cost and time expensive

• Consider optimal timing of training activities

Support in device handling

on individual levels:

 • Training for HCPs

 • Technical trainers should be familiar with study aims

 • Visualization of device-based intervention messages for subjects

• Cost and time expensive

• Consider optimal timing of training activities

Detailed assessment of adherence:

 • Questionnaires (e.g., about therapy adaptations, perceptions of tools)

 • Result analysis of both: “per protocol population” and “intention to treat population”

• Adherence to some instructions are difficult to trace

Control group management


• Limited statistical power

• Calculated cluster numbers have to be feasible, ethically justifiable, and affordable

Minimum attention to control group

• Disease management is complex

• Standard of care cannot be fully standardized

• Standard of care is often less defined and monitored than the interventional treatment

Pilot trials

• Cost and time expensive

Pretest periods

• Cost and time expensive

Third study arm

• Reduced statistical power ➔ requires more subjects ➔ cost and time expensive

Use of historical controls; retrospective data collection

• Identification of a suitable control data

• Consider progress in treatment standards

Using two separate protocols for the two groups

• Informed consent forms should be well designed to avoid inclusion of interventional aspects

Two-stage randomization

• Ethical concern

Adaptive study designs

• Changes have to be planned and defined in advance

• Implementation of adaptations has yet to be investigated