Table 3:
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.
Some studies have been given a trial nickname; where that exists, it has been listed to help identify multiple publications on the same study.
Number of sites not provided.