Table 1.
CGM-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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mauras25 DirecNet (P) | Abbott FreeStyle Flash | USA | RCT | 4–9 | ≥7 | 146 | 6 | HbA1c | SMBG | N | NIH-NICHHD, -NCRR, -RMR |
| Battelino22 SWITCH (P) | Medtronic Guardian REAL-Time Clinical | Austria, Denmark, Italy, Luxembourg, Netherlands, Slovenia, Spain | Rcrossover | 6–70 | 7.5–9.5 | 153 | 6 | HbA1c | SMBG | Y | Medtronic |
| Rasbach38 (PRO) | Dexcomb | USA | RCT | 8–17 | 6.5–10 | 120 | 24 | Survey | CGM self-efficacy | Y | NIH-NIDDK, Katherine Adler Astrove Youth Education Fund, Maria Griffin Drury Pediatric Fund, Eleanor Chesterman Beatson Fund |
| Bolinder20 IMPACT (P) | Abbott FreeStyle Libre flashb | Austria, Germany, Netherlands, Spain, Sweden | RCT | 2–17 | 7.5–11 | 241 | 6 | Hypoglycemia | SMBG | Y | Abbott |
| El-Laboudi31 JDRF-CGM (S) | Dexcom Seven, Medtronic Enlite, or Abbott Freestyle Libreb | UK | RCT | ≥8 | 7–10 | 448 | 6 | Glycemic variability | SMBG | Y | |
| vanBeers14 IN CONTROL(P) | Medtronic Enlite | Netherlands | Rcrossover | 18–70 | Any | 52 | 4 | TIR | SMBG | Y | Eli Lilly and Sanofi, in-kind support Medtronic |
| Soupal26 COMISAIR (P) | Medtronic Enlite or Dexcom G4 | Czech Republic | NRP | >18 | 7–10 | 65 | 12 | HbA1c | SMBG | Y | Agency for Healthcare Research (AZV) Czech Rep. |
| Polonsky39 DIaMonD (PRO) | Dexcom G4 | USA | RCT | ≥25 | 7.5–10 | 158 | 6 | Survey | QOL | Y | Dexcom |
| vanBeers37 IN CONTROL (PRO) | Medtronic Enlite | Netherlands | Rcrossover | 18–70 | Any | 52 | 11 | Survey | Emotional well-being | Y | Eli Lilly and Sanofi |
| Beck21 DIaMonD (P) | Dexcom G4 | USA | RCT (2:1) | ≥25 | 7.5–10 | 158 | 6 | HbA1c | SMBG | N | Dexcom |
| Heinemann18 HypoDE (P) | Dexcom G5 | Germany | RCT | ≥18 | ≤9 | 163 | 6 | Hypoglycemia | SMBG | N | Dexcom |
| Oskarsson29 IMPACT (S) | Abbott FreeStyle Libre flashb | Austria, Germany, Netherlands, Spain, Sweden | RCT | ≥18 | ≤7.5 | 167 | 6 | TBR | SMBG | N | Abbott |
| Guilmin-Crepon19 Start-In! (P) | Medtronic Enlite | France | RCT (1:1:1) | 2–17 | 7.5–11 | 151 | 12 | HbA1c | SMBG | N | French Health Ministry |
| Raviteja15.(P) | Medtronic iPRO 2 Prof. CGM | India | RCT | 2–10 | <12 | 68 | 3 | HbA1c | SMBG | Y | |
| Marsters30 (S) | Abbott FreeStyle Libre flashb | New Zealand | RCT | 13–20 | ≥9 | 64 | 6 | Cutaneous | SMBG | Y | Cure Kids, Australasian Pediatric Endocrine Group, University of Otago |
| Pratley16 WISDM (P) | Dexcom G5 | USA | RCT | ≥60 | <10 | 203 | 6 | TBR | SMBG | Y | JDRF, Leona M. and Harry B. Helmsley Charitable Trust (HCT), NIH-NCRR, -NCATS, in-kind support Dexcom |
| Soupal33 COMISAIR (E) | Medtronic Enlite or Dexcom G4 | Czech Republic | NRP | >18 | 7–10 | 94 | 36 | HbA1c | SMBG | Y | AZV, Ministry of Health Czech Rep, Dexcom |
| AlHayek27, April (P) | Abbott FreeStyle Libre flashb | Saudi Arabia | NRP | 13–19 | – | 187 | 3 | Survey | Diabetes distress | Y | None for study conduct; Publication fees by Abbott |
| AlHayek36, July (PRO) | Abbott FreeStyle Libre flashb | Saudi Arabia | NRP | 18–40 | – | 95 | 3 | Survey | Diabetes distress | Y | None for study conduct; Publication fees by Abbott |
| Seyed-Ahmadi28 GOLD (S) | Dexcom G4 | Sweden | Rcrossover | ≥18 | ≥7.5 | 137 | 17.25 | TBR | SMBG | Y | Swedish State (ALF agreement) |
| Laffel17 CITY (P) | Dexcom G5 | USA | RCT | 14–24 | 7.5–11 | 153 | 6 | HbA1c | SMBG | Y | HCT, in-kind support Dexcom |
| Lind34 SILVER (E) | Dexcom G4 | Sweden | Rcrossover | ≥18 | ≥7.5 | 107 | 12 | HbA1c | SMBG | Y | Swedish State (ALF), Dexcom |
| Secher23 (P) | Abbott FreeStyle Libre flashb | Denmark | RCT (1:1:1:1) | ≥18 | >7 | 170 | 6 | TIR | SMBG | N | Capital Region of Denmark |
| Xu13 (P) | Abbott FreeStyle Libre 1 flash | China | RCT (1:1:1) | 10–19 | 7–10 | 80 | 6 | HbA1c | SMBG | Y | National Key Research and Development Program, NSF of China, Shanghai Municipal Education Commission-Gaofeng Clinical Medicine |
| Elbalshy24 (P) | Abbott FreeStyle Libre flash vs. addition of MiaoMiao version 2 | New Zealand | Rcrossover | 2–13 | – | 55 | 4 | Survey | CGM, Parental FOH | N | Dept Women’s & Children’s Health Research Grant, Dunedin School of Medicine, Freemasons New Zealand, Health Research Council, Lottery Health Research |
| Miller35 WISDM (E) | Dexcom G5 | USA | RCT | ≥60 | <10 | 203 | 12 | Hypoglycemia | SMBG | Y | JDRF, HCT, Public Health Service Research Grant, in-kind support Dexcom |
| VanName32 SENCE (E) | Dexcom G5 | USA | RCT (1:1:1) | 2–8 | 7–9 | 143 | 12 | TIR | SMBG | N | HCT, in-kind support Dexcom |
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.
bNo further specification of the device in the paper.
SMBG self-monitoring blood glucose, TIR time in range (70–180 mg/dL).
PRO patient-reported outcome, TBR time below range (<70 mg/dL).