Table 1.
Change in Glucose Outcomes and Questionnaire Outcomes (Gold, HSF-II [Including HSF-II Behavior and Worry Subscores] and PAID Scores) from 8 Weeks to Endpoint at 16 Weeks with RT-CGM
| % Time in defined glucose range | RT-CGM group (n = 16) | Flash glucose monitoring group (n = 20) | Median change from 8 weeks to endpoint | ||||||
|---|---|---|---|---|---|---|---|---|---|
| At 8 weeks | Endpoint at 16 weeks | P | At 8 weeks | Endpoint at 16 weeks | P | RT-CGM group | FGM group | P | |
| <2.8 mmol/L | 0.8 (0.2 to 1.7) | 0.9 (0.3 to 1.5) | 0.82 | 3.8 (3.0 to 6.4) | 0.5 (0.2 to 1.4) | <0.001 | 0.0 (−0.9 to 0.3) | −3.1 (−4.6 to −2.4) | <0.001 |
| <3.0 mmol/L | 1.3 (0.4 to 2.8) | 1.3 (0.8 to 2.5) | 0.82 | 5.0 (3.7 to 8.6) | 0.8 (0.4 to 1.9) | <0.001 | 0.02 (−1.2 to 0.5) | −4.0 (−4.8 to −2.9) | <0.001 |
| <3.3 mmol/L | 2.3 (0.9 to 4.4) | 2.1 (1.4 to 4.4) | 0.73 | 6.8 (4.8 to 11.7) | 1.5 (0.7 to 2.8) | <0.001 | 0.4 (−1.7 to 0.9) | −4.8 (−6.2 to −3.2) | <0.001 |
| <3.5 mmol/L | 3.1 (1.5 to 5.9) | 3.3 (2.2 to 6.7) | 0.77 | 8.2 (6.0 to 13.2) | 2.1 (1.2 to 4.0) | <0.001 | 0.4 (−2.3 to 1.7) | −5.3 (−7.6 to −3.3) | <0.001 |
| <3.9 mmol/L | 6.2 (3.1 to 8.7) | 5.4 (3.9 to 9.7) | 0.86 | 11.0 (8.2 to 17.0) | 3.9 (2.4 to 6.7) | <0.001 | 0.4 (−0.2 to 2.1) | −6.6 (−9.4 to −3.7) | <0.001 |
| >7.8 mmol/L | 49.0 (43.9 to 56.8) | 45.6 (40.4 to 63.5) | 0.99 | 47.1 (37.4 to 53.5) | 50.2 (44.7 to 57.8) | 0.007 | −0.3 (−5.5 to 6.6) | 3.7 (−0.9 to 15.2) | 0.02 |
| >10 mmol/L | 26.7 (17.5 to 36.1) | 28.8 (15.8 to 46.3) | 0.82 | 28.0 (18.0 to 32.1) | 27.8 (23.0 to 34.3) | 0.02 | −1.0 (−5.4 to 8.5) | 4.5 (−1.5 to 9.1) | 0.18 |
| >15 mmol/L | 4.2 (1.2 to 8.8) | 4.8 (1.4 to 9.1) | 0.71 | 2.6 (1.2 to 5.1) | 2.7 (2.3 to 5.0) | 0.09 | 0.1 (−0.9 to 2.1) | 0.6 (−0.3 to 2.8) | 0.36 |
| 3.9 to 7.8 mmol/L | 43.7 (38.1 to 47.8) | 43.1 (32.1 to 54.0) | 0.69 | 40.4 (34.7 to 45.3) | 42.9 (34.9 to 49.8) | 0.68 | 1.0 (−2.6 to 3.2) | 2.2 (−5.2 to 4.7) | 0.81 |
| 3.9 to 10 mmol/L | 65.9 (54.1 to 74.8) | 64.9 (49.2 to 73.9) | 0.64 | 60.0 (54.5 to 67.8) | 67.4 (56.3 to 72.4) | 0.02 | −1.0 (−4.4 to 4.1) | 3.5 (−0.4 to 7.2) | 0.04 |
| Other outcomes | |||||||||
| Low blood glucose index | 4.8 (2.8 to 6.3) | 4.6 (3.8 to 5.9) | 0.69 | 9.1 (7.2 to 10.7) | 4.1 (3.0 to 4.9) | <0.001 | 0.2 (−1.4 to 1.2) | −4.8 (−6.2 to −2.3) | <0.001 |
| Gold score | 5.0 (3.0 to 5.0) | 4.5 (3.0 to 6.0) | 0.82 | 5.0 (3.5 to 6.0) | 4.5 (3.0 to 5.5) | 0.04 | 0 (−1 to 0.5) | 0 (−1 to 0) | 0.46 |
| HbA1c mmol/mol | 54.0 (46.0 to 62.0) | 51.5 (47.0 to 58.0) | 0.87 | 51.0 (48.5 to 59) | 52.0 (49.5 to 60.5) | 0.07 | 0.5 (−5.5 to 4.5) | 2.0 (0.0 to 3.0) | 0.49 |
| HSF-II total score | 54.0 (28.0 to 78.0) | 47.0 (29.5 to 73.2) | 0.07 | 42.0 (27.7 to 66.7) | 38.0 (27.5 to 50.5) | 0.15 | −4.5 (−10.7 to 1.7) | −1.5 (−12.0 to 4.5) | 0.94 |
| HSF-II behavior | 20.0 (11.0 to 28.5) | 18.5 (10.2 to 24.7) | 0.46 | 15.0 (11.2 to 27.7) | 15.5 (11.2 to 22.7) | 0.70 | 0.0 (−4.7 to 2.5) | −1.8 (−5.0 to 1.0) | 0.41 |
| HSF-II worry | 32.0 (16.7 to 49.7) | 29.5 (18.2 to 40.5) | 0.18 | 31.0 (15.2 to 47.0) | 21.5 (14.0 to 36.5) | 0.02 | −2.0 (−10.0 to 2.0) | −3.0 (−10.0 to 0.7) | 0.51 |
| PAID score | 36.2 (10.0 to 52.5) | 32.5 (12.5 to 38.7) | 0.23 | 27.5 (15.6 to 55.0) | 21.2 (17.8 to 38.4) | 0.11 | −1.2 (−8.7 to 2.5) | −1.2 (−7.1 to 0.9) | 0.82 |
Results are expressed as median (IQR). P values of <0.05 are significant and highlighted in bold. Outcomes based on CGM data are derived from the last 28 days in each treatment period.
HFS-II, Hypoglycaemia Fear Survey; PAID, Problem Areas in Diabetes; RT-CGM, real-time continuous glucose monitoring.