TABLE 3.
Summary of Emerging Real-World Evidence
| Published Reports | Design/Intervention | Outcome Measures | Findings |
|---|---|---|---|
| A1C reductions | |||
| Miller et al., 2020 (30) | • 6- and 12-month retrospective, observational analyses using medical/pharmacy claims database and Quest laboratory A1C values (United States) • 6- and 12-month: 774 and 207 adults, respectively, with type 2 diabetes treated with long-acting insulin or premixed insulin (n = 277 and 87, respectively) or noninsulin therapy (n = 497 and 120, respectively) • Acquisition of flash CGM |
• A1C | • A1C decreased by −0.8% (P <0.0001) in the 6-month cohort: long-acting insulin by −0.6% (P <0.0001), noninsulin by −0.9% (P <0.0001). • A1C decreased by −0.6% (P <0.0001) in the 12-month cohort: long-acting insulin by −0.5% (P = 0.0014), noninsulin by −0.7% (P <0.0001). |
| Wright et al., 2020 (31) | • 12-month, retrospective, observational study using IBM Explorys, a U.S. EHR database • 1,183 adults with type 2 diabetes using long-acting insulin or premixed insulin (n = 378) or noninsulin (n = 805) therapy • 12-month, retrospective, observational study using IBM Explorys, a U.S. EHR database |
• A1C | • A1C decreased by −1.38% (from 10.16 to 8.78%, P <0.0001) at 6 months post–flash CGM acquisition. • Greatest reductions of A1C were seen in participants with highest baseline A1C levels. |
| Eeg-Olofsson et al., 2020 (48) | • 12-month, retrospective, observational study using Swedish National Diabetes Register • 538 adults with type 1 or type 2 diabetes • Flash CGM use |
• A1C | • A1C decreased by −0.52% (P <0.0001) at 12 months. |
| Reductions in events/hospitalizations | |||
| Hirsch et al., 2020 (37) | • 12-month, retrospective, observational study using IBM MarketScan Commercial Claims and Medicare Supplemental databases • 12,521 adults with type 1 or type 2 diabetes • Acquisition of flash CGM |
• Acute ADEs for hypoglycemia or hyperglycemia | • ADE decreased from 0.245 to 0.132 events/patient-year (HR: 0.54 [95% CI 0.49–0.59], P <0.001). • Similar reductions in ADE were seen in participants with a history of performing four or more or less than four glucose tests per day. |
| Bergenstal et al., 2020 (35) | • 12-month, retrospective, observational study using IBM MarketScan Commercial Claims and Medicare Supplemental databases • 1,244 adults with type 2 diabetes • Acquisition of flash CGM |
• Acute ADEs for hypoglycemia or hyperglycemia • ACH |
• ADEs decreased from 0.158 to 0.077 events/patient-year (HR: 0.49 [95% CI 0.34–0.69], P <0.001). • ACH decreased from 0.345 to 0.247 events/patient-year (HR: 0.72 [95% CI 0.58–0.88], P = 0.002). |
| Miller et al., 2020 (33) | • 12-month, retrospective, observational study using IBM MarketScan Commercial Claims and Medicare Supplemental databases • 7,167 adults with type 2 diabetes treated with long-acting insulin or noninsulin therapy • Acquisition of flash CGM |
• Acute ADEs • Hospitalization or outpatient emergency for hypoglycemia or hyperglycemia |
• ADEs decreased at 6 months post-acquisition of flash CGM from 0.071 to 0.052 events/patient-year (HR: 0.70 [95% CI 0.57–0.85], P <0.001). • Hospitalizations decreased from 0.180 to 0.161 events/patient-year (HR: 0.87 [95% CI 0.78–0.98], P = 0.025). |
| Roussel et al., 2020 (34) | • 12-month, retrospective, observational study using the French nationwide reimbursement claims database • 33,203 individuals with type 1 diabetes and 40,955 individuals with type 2 diabetes • Flash CGM use for 12 months |
• Hospitalizations for DKA | • DKA hospitalizations decreased by 52% in participants with type 1 diabetes and by 47% in those with type 2 diabetes. |
EHR, electronic health record; IBM, International Business Machines.