Table 3.
Listing of Clinical Trials With Different CGM Systems Summarizing Key Study Information and the MARD Obtained.
| Reference | Study setting | Number of subjects | T1/T2 | Study duration | Comparison method | Calibration system | Number of calibrations per day | Overall MARD | MARD during hypos | Comments |
|---|---|---|---|---|---|---|---|---|---|---|
| Dexcom seven plus | ||||||||||
| Garg11 | Home use, with 3 in- clinic visits | 14 | T1 | 15 days (5 days/sensor) | Venous measurements (YSI); SMBG | BG meter | 2 h after sensor insertion; every 12 h thereafter | vs YSI: 16.8%, vs BG: 16.2% | Hypo (<80 mg/dL), YSI: 21.5% | |
| Luijf12 | Both (1 day in clinic and rest is home use) | 12 | T1 | 7 days | In clinic: plasma glucose (YSI); Home use: SMBG (Aviva Nano) | Accu-Chek Aviva Nano | Twice per day | In clinic: 19.2%; Home use: 16.8% | In clinic: 23.9%; Home use: 41.6 | |
| Freckmann13 | In clinic | 12 | T1 | 9 days (7 days for Dexcom Seven Plus) | Capillary BG and venous BG (YSI) | Navigator BG meter | 2 h after sensor insertion and then every 12 h | 16.7% | 31.7% | |
| Facchinetti14 | In clinic | 24 (12 from each database) | T1 | 7 days | BG samples measurements (YSI) | Not reported | According to the manufacturer’s instructions | 15.1% (15.6% study 1 & 14.7% study 2) | Study looked into two databases from 2 studies | |
| Damiano15 | In clinic | 6 | T1 | 2 days | Venous plasma glucose (GlucoScout and YSI) | Not reported | 4 calibrations with venous blood | 16.5% | ||
| Christiansen16 | In clinic | 53 | T1 (81%) & T2 (19%) | 7 days | Venous measurements (YSI) | OneTouch Ultra 2 meter | Twice daily | 16.0% | 27.0% | |
| Facchinetti17 | In clinic | 9 | T1 | 1 day | BG samples measurements (YSI) | Not reported | Twice per day | 14.1% | Median MARD | |
| Dexcom G4 platinum | ||||||||||
| Luijf18 | Clinic (from 8 am until noon) and home use | 20 | T1 | Clinic (1 day) and Home use (7 days) | Venous measurements (YSI) | Abbott Freestyle BG meter | According to manufacturer’s recommendation | Clinic: 20.5%, Home use: 16.5% | Dexcom G4 version A sensor (G4A) | |
| Christiansen16 | In clinic | 72 | T1 (83%) & T2 (17%) | 7 days | Venous measurements (YSI) | OneTouch Ultra 2 meter | Twice daily | 13.0% | 18.0% | |
| Pleus19 | In clinic | 10 | T1 | 7 days | Capillary BG measurements | Accu-Chek Aviva | 2 h after sensor insertion and then every 12 h | 11.0% | 13.7% | |
| Garcia20 | In clinic | 72 | Not reported | 7 days | Venous measurements (YSI) | Not reported | Twice daily | 13.2% | ||
| Damiano21 | In clinic | 24 (12 adults & 12 children) | T1 | 2 days | Venous measurements (GlucoScout) | GlucoScout meter | One calibration before the start of the experiment, and during the experiment | 10.8% | ||
| Matuleviciene22 | Home use | 38 | T1 | 4-6 days | Capillary and venous BG measurements | HemoCue | every 12 h | 13.9% | 20.0% | |
| Kropff23 | In clinic phase (6 h) and home use phase | 24 | T1 | 6 days | Capillary BG measurements & 6 h on the 3rd day compared to venous blood (YSI) | Accu-Chek Aviva | Twice a day after initial calibration | Clinic: 13.6%, Home: 12.2% | Clinic: 17.6%, Home: 21.2% | |
| Facchinetti17 | In clinic | 36 | T1 (32) & T2 (4) | 7 days | BG samples measurements (YSI) | Not reported | Twice daily | 11.2% | Median MARD | |
| Pleus24 | In clinic | 10 | T1 | 7 days | Capillary BG measurements | Accu-Chek Aviva | 2 h after sensor insertion and then every 12 h | 10.9% | ||
| van Beers25 | In clinic (3 sessions) and the rest Home use | 72 | T1 & T2 | Not reported | YSI for in clinic and SMBG for home use | Not reported | YSI for in clinic and SMBG for home use | 13% | ||
| Laffel26 | Both | 176 | T1 or T2 (only 1 patient) | 7 days | BG measurements or venous measurements (YSI) | LifeScan OneTouch Verio IQ | Twice daily | 17% vs YSI. & 15% vs BG | 18% vs YSI. & 21% vs BG | Pediatric subjects, two CGMs with one receiver and masked data. |
| Andelin27 | In clinic | 41 | T1 | 6 days | Capillary and venous blood samples (HemoCue) | HemoCue | Capillary glucose | Capillary: 11.7%; Venous: 13.7 | Capillary: 16.6%; Venous: 31.8% | |
| Bonora28 | Home use | 8 | T1 | 14 days | BG capillary blood | Not reported | At least twice daily | vs SMBG: 15.7%, vs FSL: > Day 1-10: 17.7%; > Day 11-14: 22.2% | FSL vs DG4P: 18.7% | Goal: Determine agreement between FSL and DG4P |
| Aberer29 | In clinic | 12 | T1 | 12 h | CGM and analyzing venous plasma glucose values every 5 min (Super GL Glucose Analyzer) | Capillary BG | every 12 h | 16.8% | 23.8% | |
| Dexcom G5 (or G4 Platinum sensor + Software 505) | ||||||||||
| Bailey30 | Both | 51 | T1 (86%) & T2 (14%) | 7 days | During clinic session: YSI, during home use: BG | Bayer Contour Next USB | Twice daily | vs YSI: 9.0% vs BG: 11.2% | ||
| Laffel26 | Both | 79 | T1 | 7 days | BG measurements or venous measurements (YSI) | Bayer Contour Next USB | Twice daily | vs YSI 10% & vs BG 13% | vs YSI 17% & vs BG 19% | Pediatric subjects, single unmasked sensor |
| Freckmann31 | Home use with 3×48 hours in-clinic visits | 20 | T1 | 14 days (7 days/sensor) | SMBG (14 days) / SMBG + venous BG (Hexokinase (HK)) during 3x 6 hours induced glucose excursions | FreeStyle Freedom Lite | 2 h after sensor insertion and then every 12 h | 14 days: 12.4%; Glucose excursions: vs HK: 16.2% vs SMBG: 14.7% | ||
| Dexcom G6 | ||||||||||
| Wadwa32 | In clinic phases for CGM assessment, otherwise patients were at home | 262 | T1 (99%) & T2 on insulin (1%) | 10 days | YSI | None (glucose values were computed retrospectively based rely on measured sensor currents) | None | 10.0% | ||
| Medtronic SofSensor | ||||||||||
| Welsh33 | Not reported | 71 adults (19-72) & 61 children (7-17) | T1 | 3 days | Not reported | Paradigm Link BG monitor | Not reported | Adults: 9.9%; Children: 10.1% | ||
| O’Neal34 | Home use | 10 | T1 | 3 days | (YSI) | Contour Link Meter, Bayer | Not reported | 18.9% | Study is only looking into nocturnal hypoglycemia, no overall MARD | |
| Christiansen16 | In clinic | 72 | T1 | 4 nights (from 18:00 until the next morning) | venous BG (Roche Hitachi 912 chemistry analyzer) | Not reported | Twice every night | 45.0% | Using the iPro algorithm | |
| Medtronic Enlite I | ||||||||||
| Kovatchev35 | In clinic | 14 | T1 | Not reported | YSI | YSI BG analyzer | According to manufacturer’s recommendation | 15.2% | 16.1% | |
| DirectNet Study Group36 | Most at home and 18 h in clinic | 30 | T1 | 7 days | BG at home and Laboratory serum glucose in clinic | One Touch® Ultra® Meter (at home) | Every 12 h at least | 14% (in clinic); 17% (at home) | Children and youth (4-17 years); Median MARD | |
| Keenan37 | In clinic | 98 | T1 (79) & T2 (18) | 7 days | Plasma glucose measurements (YSI) | Not reported | Not reported | G: 13.1% & 14.6%; V: 12.9% & 14.7% | Data were processed using the calib. Algo. of Guardian (G) and the Veo real time (V) | |
| Calhoun38 | In clinic | 54 | T1 | 69 nights | 19% YSI analyzer, 66% GlucoScout monitor, and 15%; HemoCue analyzer | Not reported | Manufacturer-recommended intervals | 15% | Median MARD | |
| Luijf18 | In clinic phase (from 8 am until noon) and a home use phase | 20 | T1 | Clinic phase (1 day) and Home use phase (6 days) | (YSI glucose analyzer) | Abbott Freestyle BG meter | According to manufacturer’s recommendation | Clinic: 16.4%; Home use: 18.9% | Clinic: 21.5% | |
| Damiano15 | In clinic | 6 | T1 | 2 days | Venous BG measurements (GlucoScout and YSI) | No reported | Average of 4.7 calibrations with venous blood | 18.0% | ||
| Freckmann39 | In clinic | 12 | T1 | 9 days (6 days for Enlite) | capillary BG measurements and venous BG (YSI) | Navigator BG meter | 1, 2, 10, 24, 72 hours after sensor insertion | 16.7% | 34.3% | |
| Mahmoudi40 | In clinic | 10 | T1 | Not reported | Plasma glucose (HemoCue glucose analyzer) | Not reported | At least three times daily | 32.1% | 62.8% | Glucose data were restricted to nighttime measurements |
| Damiano21 | In clinic | 24 (12 adults & 12 children) | T1 | 2 days | Venous BG measurements (GlucoScout) | GlucoScout meter | One calibration before the start of the experiment, during the experiments | 17.9% | ||
| Bailey41 | In clinic (3 sessions) and the rest Home use | 90 | T1 & T2 | 6 days | YSI | Bayer Contour NEXT LINK meter | Different frequencies | 1.2 calibrations daily: 14.7%; 2.8 calib. daily: 13.6% | ||
| Matuleviciene22 | Home use | 38 | T1 | 4-6 days | Capillary and Venous BG measurements | HemoCue | According to manufacturer’s recommendation | 17.9% | 34.7% | |
| Kropff23 | In clinic phase (6 h) and a home use phase | 26 | T1 | 6 days | Capillary BG fingersticks & 6 h on the 3rd day compared to venous blood (YSI) | Accu-Chek Aviva | Twice a day after initial calibration | In clinic phase: 16.6%, Home phase: 19.9% | In clinic phase: 24.6%, Home phase: 36.5% | |
| Nørgaard42 | Home use | 45 | T1 | 15 days (3 days/device) | BG capillary blood | Not reported | Mean number of 4.7 per day | 15.5% | ||
| Medtronic Guardian Sensor 3 | ||||||||||
| Aberer29 | In clinic | 12 | T1 | 12 hours | CGM and analyzing venous BG values every 5 min (Super GL Glucose Analyzer) | Capillary BG calibration | At least twice a day | 21.4% | 26.9% | Guardian Sensor 3 as part of the Medtronic MiniMed 640G |
| Christiansen43 | In clinic (3 sessions / 12-14h) and the rest Home use | 88 | T1 (62) & T2(26) | 7 days | YSI FST; using 2300 STAT Plus | Home: not reported; During FST: sensors were calibrated based on prompts from the MiniMed 640G | FST: 40-120 min after sensor insertion, 6 h and 12 h after first calibration | Minimum calibrations: 10.6%; one additional calibration: 9.6% | Guardian Sensor 3 as part of the Medtronic MiniMed 640G | |
| Abbott Navigator I | ||||||||||
| Weinstein44 | In clinic | 58 | T1 | 5 days | Venous YSI measurements | Integrated FreeStyle meter | Initially at 10 h post insertion; 12, 24, and 72h after insertion | 12.8% | 19.8% | |
| Kovatchev35 | In clinic | 14 | T1 | Not reported | YSI | YSI r | According to manufacturer’s recommendation | 15.3% | 10.3% | |
| Garg11 | Home use with 3 in- clinic visits | 14 | T1 | 15 days (5 days/sensor) | Venous YSI; SMBG | FreeStyle integrated BG meter | Initially at 10 h post insertion; 12, 24, and 72h after insertion | vs YSI:16.1%; vs BG: 15.9% | hypo (<80 mg/dL) vs YSI: 29.8% | |
| Luijf18 | In clinic phase (from 8 am until noon) and a home use phase | 20 | T1 | Clinic (1 day) and Home use (5 days) | (YSI) | Abbott Freestyle BG meter | According to manufacturer’s recommendation | Clinic: 16.5%; Home: 14.5% | Clinic: 17.4% | |
| Damiano15 | In clinic | 6 | T1 | 2 days | Venous BG measurements (GlucoScout and YSI) | No reported | One calibration with venous blood | 11.8% | ||
| Freckmann13 | In clinic | 12 | T1 | 9 days (5 days use for Navigator) | Capillary BG and venous BG (YSI) | Navigator BG meters | 1, 2, 10, 24, 72 hours after sensor insertion | 12.6% | 23.3% | |
| Damiano21 | In clinic | 24 (12 adults & 12 children) | T1 | 2 days | Venous BG (GlucoScout) | GlucoScout meter | Two calibrations before the start of the experiment, and during the experiment an average of 6.4 | 12.3% | ||
| Abbott Navigator II | ||||||||||
| McGarraugh45 | In clinic | 47 | T1 | 10 h | Venous BG vs YSI | Not reported | Not reported | 14.5% | 17.5% | |
| Leelarathna46 | AID and conventional treatment or two AID visits | 32 (12 pregnant) | T1 | Study visits: 18 h to 36 h | (YSI) | Integrated Freestyle BG meter | According to manufacturer’s recommendation | 13.9% | Only median ARD: 21.0% | Analyzed data from five AID studies |
| Thabit47 | Home use | 57 | T1 | 2 periods in the overnight studies, and 1 week for the day-and-night study | Capillary BG fingersticks | Integrated Freestyle BG meter | According to manufacturer’s recommendation | 14.2% | 30.6% | Accuracy was assessed using data from 3 studies |
| Abbott Freestyle Libre | ||||||||||
| Bailey48 | Home use with 3 in-clinic visits | 72 | T1 & T2 | 14 days | Capillary BG / venous BG (YSI) | Factory-calibrated | No calibration during 14 days of wear | vs BG: 11.4%; clinic alone with BG and YSI: 12.1% and 12.0% | ||
| Bonora28 | Home use | 8 | T1 | 14 days | BG capillary blood | Factory-calibrated | No calibration during 14 days of wear | vs BG: 15.4%, vs DG4P: >Day1-10: 17.7%; >Day 11-14: 22.2% | FSL vs DG4P: 18.7% | Determine agreement between FSL and DG4P, >3 sensor scans per day at <8 h intervals |
| Aberer29 | In clinic | 12 | T1 | 12 h | CGM and BG values every 5 min (Super GL Glucose Analyzer) | Factory-calibrated | Not reported—max. wear time: 14 days | 13.2% | 14.6% | Sensor on the back of each upper arm (two sensors total); no significant difference |
| Freckmann31 | Home use with 3×48 hours in-clinic visits | 20 | T1 | 14 days (7 days/sensor) | SMBG (14 days) / SMBG + venous BG (Hexokinase (HK)) during 3x 6 hours induced glucose excursions | Factory-calibrated | No calibration during 14 days of wear | 14 days: 13.0%; Glucose excursions: vs HK: 16.8%; vs SMBG: 15.7% | ||
| Senseonics Eversense | ||||||||||
| Kropff49 | Home use with 11 clinic visits | 71 | T1 (66) & T2 (5) | 180 days | Venous measurements (YSI) | Accu-Chek Aviva | Twice daily | 11.6% | 21.7% | |
| Christiansen50 | Home use with 7 clinic visits | 90 | T1 (61) & T2 (29) | 90 days | Home: BG (Contour next) Clinic: YSI | Contour Next USB | Twice daily | 8.8% | 40-54 mg/dL: 10.7%, 55-70 mg/dL: 9.0% | |