TABLE 2.
Baseline characteristics and treatment effects
| Study | Age (years) | Baseline HbA1c (%) | Duration of diabetes (years) | Sex, female (%) | HbA1c % reduction | Rates of hypoglycaemia (SHE) per 100 patient‐years |
|---|---|---|---|---|---|---|
| Roze et al. (2015) 12 | 27 | 8.60 | 13 | 54.5 | SAP: 0.30 | SAP vs Control: 23% reduction |
| Roze et al. (2016) 13 | 36 ± 13.6 a | 9 ± 0.9 | 17 ± 10.8 | 47.0 | SAP: 0.88 Control: 0.48* | Nil change |
| 18.6 ± 11 | 7.5 (7.2–7.9) | 12 ± 8.9 | 50.0 | Nil effect |
CSII: 2.2 SAP: 0 |
|
| Roze et al. (2016) 14 | 27.1** | 10 | 13 | 51.5 | SAP: 1.49 Control: 0.62 |
CSII: 2.2 SAP: 0 |
| Roze et al. (2017) 15 | 27 a | 8.1 | 13.2 | 51.5 |
SAP: 0.56 Control: 0.13* |
Nil change |
| 18.6 b | 7.5 | 11 | 50.5 | Nil effect |
CSII: 2.2 SAP: 0 |
|
| Conget et al. (2018) 16 | 18.6 ± 11.1 | 7.5 (7.2–7.9) | 12 ± 8.9 | 50% | N/A | CSII: 2.2 events SAP: 0 |
| Nicolucci et al. (2018) 17 | 27 ± 15.6 a | 8.1 (1.3) | 13.2 (10.8) | 51.5 | SAP: 0.56 | Nil change |
|
SAP 19.7 ± 12.9 b CSII 17.4 ± 10.6 |
SAP 7.4 (7.2–7.6) CSII 7.6 (7.4–7.9) |
SAP 12.1 (10.0) CSII 9.8 (7.4) |
SAP 57.1 CSII 43.5 |
Nil Effect |
SAP: 0 CSII: 2.2 |
|
| Roze et al. (2019) 18 | 27 ± 15.6 a | 9.0 | 13.2 ± 10.8 | 51.5 | SAP: 1.1 Control: 0.36 | Nil effect |
| 18.6 ± 11.8 b | 7.5 | 11 ± 8.9 | 50.5 | Nil Effect |
CSII: 2.2 SAP: 0 |
|
| Chaugule et al. (2017) 19 | 46 | 8.6 ± 0.7 | 19 | 47.0 |
CGM: 1.0 (SD 0.7%) Control: 0.4 (SD 0.7%) |
50% reduction |
| Wan et al. (2018) 20 |
Cont f .: 51.4 ± 10.9 CGM: 45.7 ± 13.6 |
Cont.: 8.6 ± 0.6 CGM: 8.6 ± 0.7 |
Cont.: 23.1 ± 14.5 CGM: 19.6 ± 13.6 |
Cont: 43.0 CGM: 45.0 |
N/A |
Control: 4% CGM: 2% |
| Roze et al. (2020) 21 | 43 ± 13 d | 8.6 ± 0.6 | 20 ± 14 | 44.0 |
Control: 0.4 CGM: 1 |
Control: 12.2 CGM: 4.2 |
| 46 ± 13a,* | 9.1 ± 0.4 | 20 ± 14 | N/A | Control: 0.5 CGM: 1.3 | Control: 0 CGM: 3.8 | |
| Roze et al. (2021) 22 | 47.6 ± 13 | 8.6 ± 0.6 | 20 ± 14 | 44.0 |
Control: 0.4 CGM: 1 |
Control: 12.2 CGM: 4.2 |
| Kamble et al. (2012) 23 | 41.23 ± 12.19 | 8.3 ± 0.5 | 20.23 ± 11.94 | 43.2 |
SAP: 1.0 ± 0.7 MDI: 0.4 ± 0.8 |
N/A |
| Gomez et al. (2016) 24 | 34.19 ± 17.14 | 9.0 ± 2.0 | 13.96 ± 9.91 | 46.5 | 1.5% |
SMBG: 5.22 CGM + CSII: 0.37 |
| Jendle et al. (2019) 25 | 37.8 ± 16.5 | 7.4 (0.9) | 21.7 | 55.6 |
SAP: 0.5 Control: Nil Effect |
HCL: 0 CSII: SHE 1 e : 65/SHE 2: 25 |
| Pease et al. (2020) 26 | 18 | 8.5 | 10 | 53.3 | HCL: 0.3 | HCL: 0.1 g Control: 1.98 |
| Roze et al (2021) 27 | 37.8 ± 16.5 | 7.4 (0.9) | 21.7 | 55.6 |
SAP: 0.5 Control: Nil Effect |
HCL: 0 CSII: SHE 1 e : 65/SHE 2: 25 |
| Huang et al. (2010) 28 |
Cont.: 31.8 ± 17.6 a CGM: 29.4 ± 16.3.1 a |
Cont.: 6.50 ± 0.34 CGM: 6.39 ± 0.49 |
Cont.: 18.15 ± 15 CGM: 16.28 ± 15 |
Cont.: 52 CGM: 54 |
CGM: 0.53 | Nil effect |
|
Cont.: 44.7 ± 12.4 c CGM: 41.2 ± 11.2 c |
Cont.: 7.61 ± 0.50 CGM: 7.61 ± 0.49 |
Cont.: 21.83 ± 10 CGM: 23.57 ± 11 |
Cont.: 57 CGM: 60 |
Control: gained 0.3% CGM: Maintain HbA1c |
Median hypoglycaemia duration CGM: 54 min SMBG: 91 min |
|
| McQueen et al. (2011) 29 | 40 | 7.6 ± 0.5% | ~20 | N/A | 0.50% | N/A |
| Garcia‐Lorenzo et al. (2018) 30 | 26 | N/A | N/A | N/A | 0.23% | Control: 7.9% Intervention: 9.1% |
Scenario 1: Suboptimal glycaemic control (variable definitions HbA1c > 7%, HbA1c > 8.5% * and HbA1c >10% **).
Scenario 2: At risk of hypoglycaemic events.
Scenario 3: HbA1c <7% cohort.
Scenario 4: Cohort aged >25 years.
SHE 1 requiring non‐medical assistance.
Cont – control group.
Study assumed a 95% reduction in rates of SHE.