Abstract
Background - Primary care clinicians, who take care of 90% of people with diabetes, are challenged managing patients taking insulin. Insulin-requiring patients remain poorly controlled, especially those on intensive insulin regimens. The senior author developed and taught detailed treatment protocols to 50 non-physician primary care clinicians so that they could independently manage patients with diabetes. The principles of adjusting insulin doses were computerized and subsequently cleared by the Federal Drug Administration and registered by the Confirmite Europeene.
Aims – to evaluate the effectiveness and safety of these comprehensive computerized insulin dose adjustment algorithms (called Insulin Insights).
Methods – Insulin Insights interacts with over 60 glucose meters as well as continuous glucose monitors, handles all approved insulins and analyzes 11 different insulin regimens. Insulin Insight’s algorithms that are located in electronic health records or office computers generate reports within 1-2 minutes after glucose readings are downloaded. Algorithms located on a secure, approved icloud source for remote monitoring send reports at agreed upon time intervals to primary care clinicians. The generated report includes a scatterplot of glucose readings, the values organized into before and after each meal and before bedtime, an analysis of the glucose patterns that are presented in bar graphs and recommendations for dose adjustments (if necessary) that can be accepted or modified. The new doses serve as the basis for the next report.
Results - There were 104 patients in formal studies (2 pre- post and 2 randomized control trials) evaluating the response to Insulin Insights in which changes in scheduled measured HbA1c levels were the primary outcome. Baseline HbA1c levels fell 1.8% from 9.8% to 8.0% over 4.7 months. Another 161 patients were followed in real world situations. Since HbA1c tests were not at scheduled intervals, estimated HbA1c levels based on average glucoses were analyzed in all 265 patients and also showed a significant decrease. There was no increase in hypoglycemia attesting to the safety of Insulin Insights.
Conclusion – Insulin Insights, utilized by primary care clinicians, enabled them to significantly improve glycemic control. They also educate the primary care clinicians and save them time.