Table 3.
AID-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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Buckingham82 DirecNet/ TrialNet (P) | Hybrid closed-loop control: Medtronic Paradigm or Revel with Sof-sensor | USA | RCT (2:1) | 6–45 | NA | 68 | 12 | C-peptide | Usual care | N | NIH-NICHD |
| Phillip89 MD-Logic Camp (P) | MD-Logic Artificial Pancreas system: Medtronic Paradigm Veo and Enlite sensor | Germany, Israel, Slovenia | Rcrossover | 10–18 | 7–10 | 56 | 0.067 | Hypoglycemia | SAP | Y | Sanofi, Slovenian National Research Agency, in-kind support Medtronic, Intel Israel, Dell Israel, Yael Software and Systems |
| Russell93 Bionic Pancreas (P) | Bionic pancreas: Tandem tslim X2 and Dexcom G4 | USA | Rcrossover | ≥12 | – | 52 | 0.33 | Plasma glucose | Usual care | Y | NIH-NIDDK, HCT, Earle Charlton Fund for Innovative Research in Diabetes, Frederick Banting Foundation, Ralph Faber, and John Whitlock |
| Thabit92 APCam8; AP@home04 (P) | FlorenceD2A closed-loop system: Dana R Diabecare pump and Abbott FreeStyle Navigator II | Austria, Germany, UK | Rcrossover | ≥6 | 7.5–10 or <10b | 58 | 3 | TIR | SAP | Y | Eli Lilly and Sanofi, in-kind support Medtronic |
| Nimri88 MD-Logic Home (P) | MD-Logic Artificial Pancreas system: Medtronic Paradigm Veo and Enlite sensor | German, Israel, Slovenia | Rcrossover | 10–65 | 7–9 | 75 | 1.5 | TBR | SAP | Y | Sanofi, in-kind support Medtronic |
| Tauschmann91 APCam11 (P) | FlorenceM closed-loop system: Medtronic modified 640 G, Enlite 3 sensor, and Cambridge algorithm | USA, UK | RCT | ≥6 | 7.5–10 | 86 | 3 | TIR | SAP | Y | JDRF, NIHR Cambridge Biomedical Research Center, Wellcome Strategic Award |
| Brown81 iDCL (P) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | RCT (2:1) | ≥14 | Any | 168 | 6 | TIR | SAP | Y | NIH-NIDDK |
| Benhamou77 Diabeloop WP7 (P) | Diabeloop Generation 1: Cellnovo patch-pump with Diabeloop application and Dexcom G5 | France | Rcrossover | ≥18 | ≤10 | 68 | 3 | TIR | SAP | Y | French Innovation Fund, Diabeloop |
| Kovatchev85 Feb Project Nightlight (P) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | Rcrossover | 18–70 | – | 93 | 2.5 | TBR | SAP | Y | NIH-NIDDK |
| Breton80 iDCL (P) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | RCT | 6–13 | 5.7–10 | 101 | 4 | TIR | SAP | Y | Tandem, NIH-NIDDK |
| Kovatchev84 iDCL (P) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | RCT | ≥14 | <10.5 | 127 | 3 | TBR | SAP | Y | NIH-NIDDK |
| McAuley86 JDRF.au Closed-Loop (P) | Medtronic 670 G and Enlite 3 sensor | Australia | RCT | 25–70 | ≤10.5 | 120 | 6 | TIR | Pump/MDI | Y | JDRF.au, National Health and Medical Research Council (NHMRC) of Australia |
| Bergenstal78 FLAIR (P) | DreaMed MD-Logic artificial pancreas algorithm with Medtronic 670 G and Guardian 3 sensor | USA, Germany, Israel, Slovenia | Rcrossover | 14–30 | 7–11 | 113 | 6 | TAR | AID algorithm | Y | NIH-NIDDK |
| Kanapka96 iDCL (E) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | RCT | 6–13 | 5.7–10 | 101 | 7 | TIR | SAP | Y | Tandem, NIH-NIDDK, in-kind support Tandem |
| Collyns83 (P) | Medtronic 670 G and Guardian 3 sensor | New Zealand | Rcrossover | 7–80 | <10 | 60 | 3 | TIR | PLGS | Y | Medtronic, Otago University |
| Abraham76 JDRF.au Closed-Loop (P) | Medtronic 670 G and Guardian 3 sensor | Australia | RCT | 12–25 | ≤10.5 | 172 | 6 | TIR | Usual care | Y | JDRF.au, Special Research Initiative of NHMRC, PCH Foundation, in-kind support Medtronic, Roche Diabetes Care |
| Choudhary79 ADAPT (P) | Medtronic 780 G and Guardian 3 sensor | UK, France, Germany | RCT | ≥18 | ≥8 | 82 | 6 | HbA1c | CGM/MDI | Y | Medtronic |
| Renard87 FREELIFE-KID (P/E) | Tandem tslim X2 with Control IQ and Dexcom G6 | France | RCT | 6–12 | <10 | 120 | 4.5 | TIR | 24/7 vs E/N | Y | French Health Ministry |
| Ware90 DAN05 (P) | (1) a modified Medtronic 640 G and Guardian 3 sensor (FlorenceM), (2) Dana Diabecare RS pump and Dexcom G6 (CamAPS FX) | USA, UK | RCT | 6–18 | 7–10 | 133 | 6 | HbA1c | Pump | Y | NIH-NIDDK, NIHR Cambridge Biomedical Research Center and Wellcome Strategic Award, in-kind support Abbott, Dexcom, Medtronic |
| Ekhlaspour94 April iDCL (S) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | RCT (2:1) | ≥14 | Any | 168 | 6 | TIR | Usual care | N | NIH-NIDDK, in-kind support Tandem |
| Ekhlaspour95 Aug iDCL (S) | Tandem tslim X2 with Control IQ and Dexcom G6 | USA | RCT (2:1) | ≥14 | Any | 168 | 6 | TIR | By HbA1c | Y | NIH-NIDDK, in-kind support Tandem |
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 ≥18 required an enrollment HbA1c 7.5–10% and ages 6–18 HbA1c < 10%.
MDI multiple daily injection, TAR time above range (>180 mg/dL).
TIR time in range (70–180 mg/dL), TBR time below range (<70 mg/dL).