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. 2018 Feb 21;18(2):1–160.

Table 3:

Summary of Included Studies

Author, Year Setting Study Design (Trial Name)a CGM Device Recruitment Period Inclusion Criteria Sample Size, I/C Intervention Control Study Period
Age, y Diagnosis Glucose Control Insulin Therapy Other
Beck et al, 201724
United States 24 sites
RCT (DIAMOND) Dexcom G4 October 2014–May 2016 ≥ 25 Type 1 diabetes > 1 year A1C between 7.5% and 10.0% MDI Not pregnant 105/53 CGM SMBG 24 weeks
Bergenstal et al, 201025
United States and Canada 30 sites
RCT (STAR 3) Medtronic MiniMed Paradigm REAL-Time January 2007–December 2008 1–70 Type 1 diabetes ≥ 3 months A1C between 7.4% and 9.5% MDI NA 244/241 SAP MDI with SMBG 1 year
Bukara-Radujkovic et al, 201126
Bosnia and Herzegovina 1 site
RCT Medtronic MiniMed 2006–2007 5–18 Type 1 diabetes ≥ 1 year A1C ≥ 8% MDI NA 40/40 CGM SMBG 6 months
Hermanides et al, 201127
Europe 8 sites
RCT Medtronic MiniMed Paradigm REAL-Time April 2007–January 2009 18–65 Type 1 diabetes ≥ 1 year A1C ≥ 8.2% MDI NA 43/35 SAP MDI with SMBG 26 weeks
Hommel et al, 201428
Europe 8 sites
RCT, crossover (SWITCH) Medtronic MiniMed Paradigm REAL-Time January 2008–July 2010 6–70 Type 1 diabetes ≥ 1 year A1C between 7.5% and 9.5% CSII > 6 months CGM-naïve 153 (total sample size) Sensor on Sensor off 17 months
Kordonouri et al, 201229
Europe 5 sites
RCT (ONSET) Medtronic MiniMed Paradigm REAL-Time February 2007–October 2008 1–16 Type 1 diabetes ≥ 1 year NR CSII NA 80/80 SAP CSII with SMBG 1 year
Langeland et al, 201230
Norway 1 site
RCT, crossover Medtronic MiniMed Guardian REAL-Time January 2009–March 2009 18–50 Type 1 diabetes > 3 years A1C between 7% and 10% MDI or CSII > 1 serious hypoglycemic event in previous 6 months Untreated concomitant disease 30 (total sample size) CGM SMBG 20 weeks; 4 weeks of intervention, 8 weeks of washout before crossover
Lind et al, 201731
Sweden 15 sites
RCT, crossover (GOLD) Dexcom G4 February 2014–June 2016 ≥ 18 Type 1 diabetes > 1 year A1C ≥ 7.5% MDI NA 142 (total sample size) CGM Usual care 26 weeks of intervention, 17 weeks of washout before crossover
Little et al, 201432
United Kingdom 5 sites
RCT, 2 × 2 crossover (HypoCOMPaSS) Medtronic REAL-Time NR 18–74 Type 1 diabetes, C-peptide negative Impaired hypoglycemia awareness NR NA 96 (total sample size) CGM with MDI CGM with CSII SMBG with MDI SMBG with CSII 24 weeks
Ly et al, 201333
Australiab
RCT Medtronic Paradigm Veo December 2009–January 2012 4–50 Type 1 diabetes Hypoglycemia unawareness/ impaired awareness CSII > 6 months Not pregnant 46/49 SAP with low glucose suspend CSII with SMBG 6 months
McQueen et al, 201440
United States 1 site
Retrospective cohort Medtronic MiniMed Paradigm REAL-Time or Dexcom device 2006–2011 ≥ 18 Type 1 diabetes NR NR Not pregnant 66/67 CGM with SMBG SMBG Up to 10 months
Olivier et al, 201434
Canada 2 sites
Pilot RCT Medtronic MiniMed Paradigm REAL-Time February 2009–January 2011 5–18 Type1 diabetes ≥ 1 year NR Injection therapy NA 10/10 CGM with CSII CSII with delayed CGM 4 months
Quiros et al, 201541
Europe 8 sites
Retrospective observational study of RCT (SWITCH) Medtronic MiniMed Paradigm REAL-Time January 2008–July 2010 6–70 Type 1 diabetes ≥ 1 year A1C between 7.5% and 9.5% CSII > 6 months NA 20 (total sample size) SAP CSII 3 years
Radermecker et al, 201042
Belgium 1 site
Prospective observational controlled trial Medtronic Guardian REAL-Time NR Adults Type 1 diabetes ≥ 1 year ≥ 6 capillary glucose recordings of < 60 mg/dL in 14 days CSII > 1 year NA 13 (total sample size) CGM SMBG 12 weeks
Rosenlund et al, 201535
Denmark 2 sites
RCT Medtronic MiniMed Paradigm Veo February 2012–December 2014 18–75 Type 1 diabetes A1C ≥ 7.5% MDI GFR at least 45 mL/min/ 1.73 m2 No other concomitant disease; no pregnancy 26/29 SAP MDI with SMBG 1 year
Rubin and Peyrot, 201236
United States and Canada 30 sites
RCT (STAR 3) Medtronic MiniMed Paradigm REAL-Time January 2007–December 2008 7–70 Type 1 diabetes ≥ 3 months A1C between 7.4% and 9.5% MDI < 2 hypoglycemic events in previous year Not pregnant 243/238 SAP MDI with SMBG 1 year
Slover et al, 201237
United States and Canada 30 sites
RCT (STAR 3) Medtronic MiniMed Paradigm REAL-Time January 2007–December 2008 7–18 Type 1 diabetes ≥ 3 months A1C between 7.4% and 9.5% MDI < 2 hypoglycemic events in previous year 78/78 SAP MDI with SMBG 1 year
Soupal et al, 201643
Czech Republic 1 site
Prospective controlled trial Medtronic MiniMed Paradigm Veo NR > 18 Type 1 diabetes > 2 years A1C between 7% and 10% MDI or CSII No concomitant disease; not pregnant or planning pregnancy 27/38 SAP CGM with MDI SMBG with CSII SMBG with MDI 52 weeks
Tumminia et al, 201538
Italy 1 site
RCT, crossover Medtronic MiniMed Guardian REAL-Time January–March 2012 18–60 Type 1 diabetes A1C > 8% MDI or CSII Middle-class socioeconomic status; no concomitant disease; not pregnant or planning pregnancy 20 (total sample size) CGM SMBG 14 months; 6 months of intervention, 2 months of washout before crossover
van Beers et al, 201639
Netherlands 2 sites
RCT (IN CONTROL) Medtronic MiniMed Paradigm Veo March 2013–February 2014 18–75 Type 1 diabetes Impaired hypoglycemia awareness CSII or MDI No concomitant disease; not pregnant 26/26 CGM SMBG 44 weeks; 16 weeks of intervention, 12 weeks of washout before crossover

Abbreviations: A1C, glycated hemoglobin; CGM, continuous glucose monitoring; CSII, continuous subcutaneous insulin infusion (insulin pump); GFR, glomerular filtration rate; I/C, intervention/control; MDI, multiple daily injections; NA, not applicable; NR, not reported; RCT, randomized controlled trial; SAP, sensor-augmented pump; SMBG, self-management of blood glucose.

a

Some studies have been given a trial nickname; where that exists, it has been listed to help identify multiple publications on the same study.

b

Number of sites not provided.