Characteristics of study subjects at baseline
| Variable | T1D intervention | T1D control | T1D all | Historical controls |
| N | 20 | 21 | 41 | 40 |
| Male sex (N) | 12 (60%) | 10 (48%) | 22 (54%) | 25 (63%) |
| Age (years) | 14.6 (0.9) | 14.6 (0.8) | 14.6 (0.8) | 14.7 (1.0) |
| Duration of diabetes (years) | 8.1 (3.6) | 7.9 (3.8) | 8.1 (3.7) | |
| Continuous subcutaneous insulin infusion | 13 | 14 | 27 | |
| Insulin multiple daily injections | 7 | 7 | 14 | |
| Smoking (n) | 1 (5%) | 0 | 1 (2%) | 0 |
| Height (cm) | 167.8 (7.2) | 167.4 (6.2) | 167.6 (6.6) | 165.7 (10) |
| Weight (kg) | 65.1 (12.0) | 61.7 (13.4) | 63.3 (12.7) | 58.6 (13.0) |
| BMI (kg/m2) | 23.1 (3.7) | 22.0 (4.4) | 22.5 (4.1) | 21.2 (3.5) |
| BMI z-score | 0.76 (0.88) | 0.39 (1.02) | 0.57 (0.96)*** | 0.22 (0.91) |
| Waist (cm) | 78.7 (9.3) | 74.6 (10.4) | 76.6 (10.0) | NA |
| Waist-to-hip ratio | 0.84 (0.06) | 0.81 (0.05) | 0.83 (0.05) | NA |
| Waist-to-height ratio | 0.47 (0.05) | 0.45 (0.06) | 0.46 (0.06) | NA |
| Lean body mass (kg)† | 40.7 (7.1) | 38.7 (6.1) | 39.7 (6.6) | 42.5 (8.9) |
| Fat mass (kg)† | 17.7 (7.0) | 17.0 (8.9) | 17.3 (7.9) | 16.2 (5.8) |
| Body fat (%)† | 28.9 (7.8) | 28.4 (9.1) | 28.6 (8.3) | 27.6 (5.3) |
| Body surface area (m2) | 1.73 (0.18) | 1.69 (0.19) | 1.71 (0.19) | 1.64 (0.22) |
| Tanner stage | ||||
| M2/P3 | 0 | 1 | 1 | NA |
| M4/P3-P4 | 0 | 3 | 3 | |
| M5/P5 | 8 | 7 | 15 | |
| G2P2 | 0 | 1 | 1 | |
| G3P2-P3 | 5 | 2 | 7 | |
| G4P3-P4 | 5 | 4 | 9 | |
| G5P5 | 1 | 1 | 2 | |
| Missing data | 1 | 2 | 3 | |
| Laboratory data | ||||
| HbA1c (mmol/mol) | 87.5 (13.7) | 84.3 (11.9) | 85.9 (12.7) | |
| HbA1c (%) | 10.2 (1.2) | 9.9 (1.1) | 10.0 (1.2) | |
| 1,5-Anhydroglucitol (μg/mL) | 2.16 (1.16) | 2.37 (1.16) | 2.26 (1.32) | |
| Continuous glucose monitoring (CGM)‡ | ||||
| Mean (mmol/L) | 12.2 (2.4) | 11.4 (2.2) | 11.7 (2.3) | |
| SD (mmol/L) | 4.8 (1.3) | 5.0 (1.4) | 4.9 (1.4) | |
| CV (%) | 39.2 (9.0) | 45.1 (13.3) | 42.9 (12.1) | |
| Time-in-range (%) | 33 (21) | 36 (11) | 35 (16) | |
| Total cholesterol (mmol/L) | 4.46 (0.75) | 4.83 (1.12) | 4.65 (0.96) | |
| HDL cholesterol (mmol/L) | 1.53 (0.35) | 1.71 (0.45) | 1.62 (0.41) | |
| LDL cholesterol (mmol/L) | 2.77 (0.73) | 2.95 (1.00) | 2.86 (0.87) | |
| Triglycerides (mmol/L) | 1.15 (0.62) | 1.11 (0.99) | 1.13 (0.82) | |
| Alanine aminotransferase (U/L) | 14 (5) | 20 (14) | 17 (11) | |
| Gamma-glutamyltransferase (U/L) | 15 (7) | 17 (12) | 16 (9) | |
| hs-CRP (mg/L) | 0.54 (0.10–9.64) | 0.90 (0.10–11.59) | 0.56 (0.10–11.59) | |
| Microalbuminuria (present)§ | 2 | 2 | 4 | |
Data are presented as mean (SD) or as count and percentage. hs-CRP is presented as median (range).
***p<0.001 between historical controls and T1D All (and BMI z-score different from population mean for T1D All), other comparisons between historical controls and T1D all as well as T1D controls vs T1D intervention were statistically non-significant (p>0.05).
†Calculated body composition data based on formula is reported for historical controls.26
‡CGM data available for 18 controls with T1D and 11 T1D interventions at baseline. CGM mean is mean glucose, CGM SD is SD of glucose variability, CGM CV is coefficient of variation (SD/mean) and CGM time-in-range is proportion of time glucose between 3.9 and 10.0 mmol/L during continuous glucose monitoring.
§Microalbuminuria data at baseline available in 37/41 patients with T1D; microalbuminuria was defined as present when albumin-to-creatinine ratio was >3.5 mg/mmol in spot urine.
BMI, body mass index ; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; hs-CRP, high-sensitivity C reactive protein; LDL, low-density lipoprotein; NA, not assessed; T1D, type 1 diabetes.