Skip to main content
. 2021 Jan;39(1):64–71. doi: 10.2337/cd20-0076

TABLE 2.

Summary of Recently Published Real-World, Prospective, Observational Studies

Published Report Design/Intervention Outcome Measures Findings
Charleer et al., 2020 (23)

  • 12-month, prospective, observational, multicenter, cohort study (Belgium)

  • 1,913 adults with type 1 diabetes

  • Use of flash CGM

  • Hospitalization with DKA and/or severe hypoglycemia

  • Hypoglycemia

  • Absenteeism

  • QoL

  • Hospitalizations decreased from 3.3 to 2.2% (P = 0.031).

  • Severe hypoglycemic events decreased from 14.6 to 7.8% (P <0.0001).

  • Hypoglycemic comas decreased from 2.7 to 1.1% (P = 0.001).

  • Fewer people were absent from work (2.9 vs. 5.8%).

  • Questionnaire-derived measures of treatment satisfaction improved.
Fokkert et al., 2019 (24)

  • 12-month, prospective nationwide registry (the Netherlands)

  • 1,365 adults with type 1 diabetes (77%), type 2 diabetes (16%), or other diabetes (7%)

  • Use of flash CGM

  • A1C

  • Hypoglycemia

  • Diabetes-related hospitalizations

  • Absenteeism

  • QoL

  • A1C decreased from 64.1 to 60.1 mmol/mol (difference of −4 [95% CI −6 to 3] mmol/mol; P <0.001).

  • In participants with a baseline A1C >70 mmol/mol, the A1C decrease was −9 (95% CI −12 to 5) mmol/mol.

  • The proportion of participants who reported hypoglycemia decreased from 93.5 to 91.0% (P <0.05).

  • The diabetes-related hospital admission rate (per year) decreased from 13.7 to 4.7% (P <0.05).

  • Absenteeism (per 6 months) decreased from 18.5 to 7.7% (P <0.05).

  • Questionnaire-derived measures of QoL improved.
Kröger et al., 2020 (32)

  • European pragmatic, parallel retrospective, noninterventional chart review study

  • 363 adults with type 2 diabetes

  • Use of flash CGM over 3–6 months

  • A1C

  • Mean (± SD) A1C levels were reduced by 9.6 ± 8.8 mmol/mol (0.9 ± 0.8%, P <0.0001) in Austria, 8.9 ± 12.5 mmol/mol (0.8% ± 1.1%, P <0.0001) in France, and 10.1 ± 12.2 mmol/mol (0.9% ± 1.1%, P <0.0001) in Germany compared with levels recorded up to 90 days before starting use of the device.

  • No significant differences were detected for age, sex, BMI, or duration of insulin use.
Tyndall et al., 2019 (25)

  • 8-month, prospective observational study (United Kingdom)

  • 900 adults with type 1 diabetes

  • Use of flash CGM

  • SMBG comparator group (n = 518)

  • A1C

  • Hypoglycemia

  • Hospitalization

  • QoL

  • A1C levels decreased by 0.6% (P <0.001) among participants with a baseline A1C ≥7.5%; there was no change in the comparator group.

  • The percentage of participants who achieved an A1C <7.5% increased from 34.2 to 50.9% (P <0.001).

  • More symptomatic (OR 1.9, P <0.001) and asymptomatic (OR 1.4, P <0.001) hypoglycemia was reported with flash CGM.

  • Hospitalizations for DKA were reduced (P = 0.043) with flash CGM.

  • Participants experienced less regimen-related and emotional distress, but more patients had elevated anxiety and depression with flash CGM use.
Paris et al., 2018 (26)

  • 12-month, observational study (Belgium)

  • 120 adults with type 1 diabetes

  • Use of flash CGM

  • A1C

  • Scanning frequency

  • Hypoglycemia

  • A1C levels decreased from 8.51 to 8.16% (P <0.0001) among participants with baseline A1C >7.5%.

  • Number of daily scans was negatively correlated with decreased A1C.

  • Number of hypoglycemic events (<70 mg/dL) increased from 16.9 to 22.9 events per month (P <0.05).

  • No severe hypoglycemic events were reported.

  • Less fear of hypoglycemia was reported.
Messaaoui et al., 2019 (27)

  • 12-month, prospective, observational study (Belgium)

  • 335 children/adolescents (10.9–16.3 years of age) with type 1 diabetes

  • Use of flash CGM

  • Hypoglycemia

  • Hypoglycemia change

  • Use of SMBG

  • A1C

  • Acceptance

  • Adverse events

  • Proportion of flash CGM continuers who experienced a severe hypoglycemic event decreased by 86% (P = 0.037); no change was seen in the SMBG group.

  • SMBG use decreased during use of flash CGM from 4.3 to 0 tests per day; SMBG use did not change in the SMBG group.

  • No significant changes in A1C occurred with either flash CGM or SMBG monitoring.

  • A total of 278 participants (83.2%) switched from SMBG to flash CGM, 234 participants were still using their device at end of the follow-up period, and 44 (15.8%) reverted to SMBG after a median use of 5.3 months.

  • Discontinuers reported more frequent occurrence of adverse events than continuers, including premature loss of sensor (31.8 vs. 12.4%), skin reactions (18.2 vs. 2.6%), and local pain (6.8 vs. 0%) (all P <0.001).

  • Discontinuation of flash CGM was associated with longer duration of diabetes and higher baseline A1C level.
Pintus et al., 2019 (28)

  • 12-month, prospective study (UK)

  • 52 children (4 months to 17 years of age) with type 1 diabetes

  • Use of flash CGM with education/support from health care professionals

  • A1C

  • QoL

  • Improvements were seen in A1C post–flash CGM compared with values at 12 (P <0.04), 6 (P <0.04), and 3 months (P = 0.012) pre–flash CGM use.

  • Questionnaire-derived measures of QoL improved (P = 0.014), diabetes symptoms decreased (P = 0.018), and treatment barriers were reduced (P = 0.035).
Al Hayek et al., 2019 (29)

  • 12-week, prospective study (Saudi Arabia)

  • 33 adolescents/young adults (14–21 years of age) with type 1 diabetes

  • Use of flash CGM

  • Well-being

  • Questionnaire-derived measures of well-being improved: mean (± SD) DTSQ score increased from 14.4 ± 6.5 to 32.1 ± 1.8 (P <0.001), and percentage score for the WHO-5 Well-Being Index increased from 45.1% at baseline to 93.6% (P <0.001).

DTSQ, Diabetes Treatment Satisfaction Questionnaire; OR, odds ratio.