Table 3.
Pivotal and age expansion studies for commercialized AID systems.
| AUTHOR / PUBLICATION | DEVICE | STUDY DESIGN | STUDY DURATION | STUDY POPULATION | HbAlc AT BASELINE | RESULTADOS |
|---|---|---|---|---|---|---|
| Garg SK et al. Diabetes Technol Ther 2017 [82] | Medtronic 670 G™ | Non-randomized One single arm | 3 months | Adolescents > 14 y (n = 30) Adults (n = 94) |
Adolescents 7.7% Adults 7.3% |
Adolescents: • TIR ↑ from 60% to 67% • TBR ↓ from 4.3% to 2.8% • Adults: • TIR ↓ from 69% to 74% • TBR ↓ from 6.4% to 3.4% |
| Tauschmann M et al. Lancet 2018 [132 | CamAPS FX™ | RCT Parallel groups CL vs SAP |
3 weeks | n = 24 children (2–7 years) | 7.4% | For both groups • TIR: 70–72% • TBR: 4.5–4.7% |
| Forlenza GP et al. Diabetes Technol Ther 2019 [145] | Medtronic 670 G™ | Non-randomized One single arm | 3 months | n = 105 children (7–13 years) | 7.9% | • TIR ↑ from 56% to 65% • TBR ↓ from 4.7% to 3.0% |
| Brown SA et al. NEJM 2019 [110] | Tandem Control IQ™ | RCT Parallel groups Control IQ vs SAP |
6 months | n = 168 adults and adolescents > 14 years | 7.4% | Control-IQ vs SAP: • TIR ↑: 71% vs 59% • TBR ↓: 1.6% vs 2.3% |
| Breton MD et al. NEJM 2020 [115] | Tandem Control IQ™ | RCT Parallel groups Control IQ vs SAP |
4 months | n = 101 children (6–13 years) | 7.6–7.9% | Control-IQ vs SAP: • TIR ↑: 67% vs 55% • TBR ↔: 1.6% vs 1.8% |
| Sherr JL et al. Diabetes Technol Ther 2020 [146] | OmniPod 5 | Non-randomized (Safety and performance) | 96 h | Children (n = 15), Adolescents 6–18 y (n = 10) Adults 18–65 y (n = 11) |
Children 8.0% Adolescents 8.4% Adults 7.4% |
Adults (ST vs CL) • TIR ↑: from 68% to 73% • TBR ↓: from 3.2% to 1.7% • Adolescents (ST vs CL) • TIR ↑: from 60% to 59% • TBR ↓: 2.8% vs 2.4% • Children (ST vs CL) • TIR ↓: from 54% to 69% • TBR ↑: from 2.2% to 1.9% |
| Bergenstal RM et al. Lancet 2021 [90] | Medtronic 780 G™ | RCT Cross-over ACHL vs 670 G |
3 months | n = 113 adolescents and young adults (14–29 years) |
7.9% | AHCL vs 670 G: • TIR ↑: 67% vs 63% • TBR ↔: 2.1% vs 2.1% |
| Ekhlaspour L et al. Diabetes Technol Ther 2021 [119] | Control-IQ | Non-randomized (Safety and performance) | 48 h | n = 12 Children 2–5 years |
7.3% | • TIR ↑ from 63% to 71% • TBR ↓ from 3.7% to 1.5% |
| Forlenza G et al. Diabetes Technol Ther 2021 [147] | OmniPod 5 | Non randomized (one single-arm) | 28 days | 18 adults and 18 children (aged 6–70 years) | Children 7.8% Adults 7.1% | 1. Children in 3 days 130 mg/dl target: 61% 2. Children in 3 days 140 mg/dl target 64.8% 3. Children in 3 days 150 mg/dl target 53.5% 4. Children in 5-days free-choice target 64.9% 5. Adults in 3 days 130 mg/dl target 75.1% 6. Adults in 3 days 140 mg/dl target 67.6% 7. Adults in 3 days 150 mg/dl target 63.7% 8. Adults in 5-days free-choice target 72.5% VS 1. Children in 14-days ST 51% 2. Adults in 14-days ST 65% |
| Brown S et al. Diabetes Care 2021 [148] | OmniPod 5 | RCT CL vs SAP |
3 months | 235 participants (aged 6–70 years) - Children in 3 months HCL (n. 111) - Adults in 3 months HCL (n. 124) |
Children 7.8% Adults 7.1% |
CL vs ST Children • TIR 52% vs 68% • TBR 2.3% vs 0.8% Adults • TIR 65% vs 74% • TBR 3.4% vs 1.4% |
| Ware J et al. NEJM 2022 [138] | CamAPS FX™ | Randomized CL vs SAP | 16 weeks | n = 44 Children 1–7 y |
7.3% | • TBR = 4.9 vs 4.5% • TIR ↑ 71.6 vs 62.9% |
| Sherr JL et al. Diabetes Care 2022 [149] | OmniPod 5 | Non randomized (one-single arm) | 13 weeks | N = 80 Children 2–5.9 y |
7.4% | • ↑ TIR: From 57% to 68% • ↓ TBR: From 3.4% to 2.4% |
RCT: Randomized Controlled Trial; CL: closed loop; SAP: sensor-augmented pump; AHCL: Advanced Hybrid Closed loop; ST: Standard Therapy