Table 2.
Pump, SAP, LGS, PLGS, and decision support tools-related clinical trial publications included in the systematic review (2012–2022).
| Author; year of publication; trial cohort if applicable; analysis type: primary (P), secondary (S), extension (E), (PRO) | System or product studied | Locations (trial sites) | Study designa | Age range (yrs) | HbA1c (%) Range | # Random-ized | Trial duration (mos) | Primary outcome | Comparator/ assessed measure | Sig (Y/N) | Funding |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pump/SAP | |||||||||||
| Kordonouri57 Pediatric Onset Study (E) | Medtronic Paradigm, Enlite sensor | Austria, France, Germany, Poland | RCT | 1–16 | NA | 131 | 24 | HbA1c | SMBG/MDI | N | Medtronic |
| Slover56 STAR 3 (S) | Medtronic Paradigm REAL-Time | USA, Canada | RCT | 7–18 | 7.4–9.5 | 156 | 12 | HbA1c | MDI | Y | Medtronic |
| Rubin61 STAR 3 (PRO) | Medtronic Paradigm REAL-Time | USA, Canada | RCT | 7–70 | 7.4–9.5 | 485 | 12 | Survey | HRQOL | Y | Medtronic |
| Peyrot60 STAR 3 (PRO) | Medtronic Paradigm REAL-Time | USA, Canada | RCT | 7–70 | 7.4–9.5 | 485 | 12 | Survey | Satisfaction | Y | Medtronic |
| Tanenberg59 STAR 3 (PRO) | Medtronic Paradigm REAL-Time and Sof-Sensor | USA, Canada | RCT | 7–70 | 7.4–9.5 | 244 | 12 | HbA1c | SAP | Y | Medtronic, in-kind support LifeScan, Bayer Healthcare, Becton Dickinson |
| Rosenlund55 (P) | Medtronic Paradigm Veo, Enlite sensor | Denmark | RCT | 18–75 | ≥7.5 | 60 | 12 | UACR | SMBG/MDI | N | Medtronic |
| Beck54 DIaMonD (P) | Insulet Omnipod and Dexcom G4 | USA | RCT | ≥25 | 7.5–10 | 75 | 6.5 | TIR | MDI | Y | Dexcom |
| Speight58 HypoCOMPaSS (PRO) | Medtronic Paradigm Veo System | UK | RCT | 18–74 | – | 96 | 24 | Survey | Satisfaction | Y | Diabetes UK |
| Messer62 (PRO) | NA | USA | NRP | 12–19 | – | 411 | 0 | Survey | QOL | Y | HCT |
| LGS/PLGS | |||||||||||
| Bergenstal66 ASPIRE (P) | Medtronic Paradigm Veo, Enlite sensor | USA | RCT | 16–70 | 5.8–10 | 247 | 3 | Hypoglycemia | SAP | Y | Medtronic |
| Ly72 (P) | Medtronic Paradigm Veo, Enlite sensor | Australia | RCT | 4–50 | ≤8.5 | 95 | 6 | Hypoglycemia | SAP | Y | JDRF, in-kind support Medtronic |
| Buckingham68 IN HOME CLOSED LOOP (P) | Medtronic Paradigm Veo, Enlite sensor | USA, Canada | Rcrossover | 4–14 | ≤8.5 | 81 | 1.3 | TBR | SAP | Y | NIH-NIDDK, JDRF, JDRF CCTN |
| Weiss73 May ASPIRE (S) | Medtronic Paradigm Veo System | USA | RCT | 16–70 | 5.8–10 | 247 | 3 | Hypoglycemia | NH predictors | Y | Medtronic |
| Weiss74 Aug ASPIRE (S) | Medtronic Paradigm Veo System | USA | RCT | 16–70 | 5.8–10 | 247 | 3 | Hypoglycemia | Correlate A1c/NH | Y | Medtronic |
| Calhoun69 IN HOME CLOSED LOOP (S) | Medtronic Paradigm Veo, Enlite sensor | USA, Canada | Rcrossover | 4–45 | ≤8.5 or ≤8.0b | 127 | 1.5 | Hypoglycemia | SAP | Y | NIH-NIDDK, JDRF, JDRF CCTN |
| Battelino65 (P) | Medtronic 640 G and Enlite sensor | Israel, Slovenia | RCT | 8–18 | ≤10 | 100 | 0.5 | Hypoglycemia | SAP | Y | Faculty of Medicine, University of Ljubljana, Slovene National Research Agency, in-kind support Medtronic |
| Forlenza70 PROLOG (P) | Tandem t:slim X2 with Basal-IQ and Dexcom G5 | USA | Rcrossover | ≥6 | – | 103 | 1.5 | TBR | SAP | Y | Tandem |
| Gomez71 (P) | Medtronic 640 G and Enlite sensor | Colombia | NRP | 6–79 | – | 55 | 3 | HbA1c | NA | Y | |
| Abraham64 PLGM (P) | Medtronic 640 G and Enlite sensor | Australia | RCT | 8-20 | <10 | 169 | 6 | Hypoglycemia | SAP | Y | JDRF.au, Australian Research Council Special Research Initiative, in-kind support Medtronic |
| Bosi67 SMILE (P) | Medtronic 640 G and Enlite sensor | UK, Canada, France, Italy, Netherlands | RCT | 24–75 | 5.8–10 | 153 | 6 | Hypoglycemia | SMBG/pump | Y | Medtronic |
| Decision support tools | |||||||||||
| Nimri47 ADVICE4U (P) | AI-DSS; The DreaMed Advisor Pro | USA, Germany, Israel, Slovenia | RCT | 10–21 | 7–10 | 138 | 6 | TIR | Physician guidance | Y | HCT |
| Bisio46 (P) | Dexcom G5 and inControl Advice (TypeZero Technologies) | USA | RCT (2:1) | ≥15 | – | 80 | 3 | TIR | CGM/MDI | N | Abbott |
aAll trials, if randomized, were randomized 1:1 unless the randomization scheme is listed in this column. RCT randomized controlled trial, RcrossoverT randomized crossover trial, NRP non-randomized prospective.
bAges 4–14 required an enrollment HbA1c ≤ 8.5% and ages 15–45 HbA1c ≤ 8.0%.
SMBG self-monitoring blood glucose, MDI multiple daily injection.
PRO patient-reported outcome, NH nocturnal hypoglycemia.
TIR time in range (70–180 mg/dL), TBR time below range (<70 mg/dL).
UACR urine albumin:creatinine ratio.