This pilot randomized trial sought to extend a diabetes case management intervention used previously among type 2 diabetes patients to a sample of younger adults with type 1 diabetes and to test whether the positive intervention effects observed in a general medicine clinic could be replicated in a subspecialty clinic.
This study found no treatment effect on A1C, although the observed trend was consistent with the study hypotheses. An effect of 0.48% would be clinically significant if replicated in a larger trial with greater statistical power, but it appears we were underpowered to detect such a difference. It is also important to consider the limited uptake of the intervention as potentially restricting its effect.
Although the majority (61%) of patients had some engagement, less than one-quarter of intervention arm participants used the study resources consistently. We believe more research is needed to clarify the extent to which this intervention can add value for patients in similar treatment settings, especially as technology continues to improve with real-time continuous glucose sensors.
We found the LWD intervention to have a statistically significant treatment effect on patients' self-efficacy. Previous research has shown self-efficacy constructs to be highly predictive of self-care behavior among younger type 1 diabetes patients both cross-sectionally and prospectively.22
As such, there is likely a benefit to increasing self-efficacy even in the absence of an effect on A1C.
There are several strengths to our approach. First, by completing a randomized trial with an intent-to-treat analysis, the observed effects are likely true impacts of the LWD program. Second, by standardizing the Websites and as using a single case manager, we limited several sources of potential bias in the delivery of the intervention.
There are also several limitations to our findings. The study selected a specific subsample of patients with diabetes whose disease was moderately to poorly controlled and who had a multiple daily injection regimen. As such, it is difficult to predict how the intervention might provide benefit for more tightly controlled patients or those receiving continuous subcutaneous insulin infusion.
Because of the small size of this pilot trial, we cannot tease apart which intervention components might have been more influential than others. We observed reasonably large number of patients who failed to fully engage with the intervention resources, but saw no significant differences in baseline demographic or clinical characteristics between users and nonusers and did not have large enough samples to directly quantify the differential effects of different “doses” of the intervention on study outcomes.
The study was further limited by the lack of prespecified collection dates for the A1C tests and reliance on pre-existing EMR data. While it appears as if missingness in the A1C variable did not bias our results, it is important to consider the added confidence that could be realized with lower levels of missing outcome data. Finally, the use of a single case manager implementing the intervention may limit generalizability.
In summary, we observed preliminary evidence in this pilot study that suggests internet-based case management may provide added benefit beyond usual care for patients with moderately to poorly controlled type 1 diabetes, even among patients receiving care at a subspecialty clinic. The greatest benefit observed in this study is a bolstering of diabetes-specific self-efficacy, which may help patients engage in more effective self-care behaviors.
While the lack of a convincing treatment benefit in glycemic control makes it difficult to recommend widespread use of this or similar interventions based on this trial alone, we believe the observed trends warrant larger trials to assess impact on glycemic control and other clinical outcomes (low-density lipoprotein, blood pressure). Larger trials should also seek to identify the most important intervention components and relevant populations for the intervention.