Effect of Incorporating Computerized Insulin Dose Adjustment Algorithms into a Remote Patient Monitoring Program on HbA1c Levels in Patients with Type 2 Diabetes

Abstract

Aims: To evaluate the effect of Federal Drug Administration-cleared computerized insulin dose adjustment algorithms (CIDAAs) incorporated into a Remote Patient Monitoring (RPM) program on HbA1c levels. Material & Methods: Type 2 patients receiving insulin for >6 months with HbA1c levels ≥8.0% enrolled in a Medicare Advantage plan were recruited into 3 arms; Group A (RPM plus CIDAAs, N=40), Group B (RPM but no CIDAAs, N=42), and Group C (usual care with no RPM or CIDAAs, N=33). In Groups A and B, glucose readings of >200 mg/dL and <70 mg/dL triggered alerts and health educators contacted patients for counseling to avoid future episodes. Results: Baseline HbA1c levels (% ± SD) were not statistically different among Groups A (9.5 ± 1.5), B (9.2 ± 1.1) and C (9.0 ± 0.9). At 6 months, HbA1c levels fell twice as much in Group A (-1.5 ± 1.0) as in Groups B (-0.7 ±1.5) and C (-0.7 ± 1.2) (P <0.001). Alerts >200 mg/dl were significantly less in Group A (N=942) than in B (N=1111) (P = 0.002) but alerts <70 mg/dL were not significantly different (235 vs 209). In Group A, baseline per patient daily insulin doses of 78 units rose 40% to 109 units. Six patients in Group C had emergency room visits for hypoglycemia but none in Groups A and B. Conclusions: The RPM program lessened clinical hypoglycemic risk but required CIDAAs to markedly increase insulin doses effectively and safely to significantly lower HbA1c levels twice as much as either RPM alone or usual care.

Real‐world evidence for computerized insulin dose‐adjustment algorithms in the effective use of continuous glucose monitoring by primary care clinicians

“…However, in randomized controlled studies, they were ineffective in improving glycaemic control without pharmacological intervention. 4,8 To be effective, RPM programmes require ongoing insulin dose-adjustment recommendations by experienced clinicians (most often endocrinologists) [9][10][11] that can also be supplied by CIDAAs. In addition to improved glycaemic control, there are two other benefits to using remote glucose monitoring and Insulin Insights.…”

“…Although the CGM devices used in this study were brought in for downloading, remote patient monitoring (RPM) programmes are used regularly by insulin‐requiring patients. However, in randomized controlled studies, they were ineffective in improving glycaemic control without pharmacological intervention 4,8 . To be effective, RPM programmes require ongoing insulin dose‐adjustment recommendations by experienced clinicians (most often endocrinologists) 9–11 that can also be supplied by CIDAAs.…”

“…In addition to improved glycaemic control, there are two other benefits to using remote glucose monitoring and Insulin Insights. Adjusting insulin doses telephonically using RPM and Insulin Insights saved time for PCCs, 3,4 allowing them to see more patients, as well as to deal with other issues in their insulin‐requiring patients during their in‐person visits. Another potential benefit for PCCs is an educational one.…”

“…These CIDAAs (Insulin Insights) have been US Food and Drug Administration-cleared and CE markregistered, and, in more than 200 patients taking insulin for at least 6 months, have proved to be beneficial in helping PCCs significantly lower those patients' HbA1c levels from initial values of 8.0% or higher. [3][4][5] After each measurement, fingerstick glucose readings were sent to a secure, Health Insurance Portability and Accountability Act-approved cloud server containing the algorithms, where they were analysed. Every 2-3 weeks, reports were sent to PCCs with recommended insulin dose adjustments that could be accepted or modified.…”

“…Recently, these principles were incorporated into computerized insulin dose‐adjustment algorithms (CIDAAs) to facilitate using insulin by PCCs. These CIDAAs (Insulin Insights) have been US Food and Drug Administration‐cleared and CE mark‐registered, and, in more than 200 patients taking insulin for at least 6 months, have proved to be beneficial in helping PCCs significantly lower those patients’ HbA1c levels from initial values of 8.0% or higher 3–5 . After each measurement, fingerstick glucose readings were sent to a secure, Health Insurance Portability and Accountability Act‐approved cloud server containing the algorithms, where they were analysed.…”