Table 2.
Study, Patient, Intervention, and Outcome Characteristics
| Characteristics | Number (% out of 65) |
|---|---|
| Study characteristics | |
| Setting | |
| Multi-national | 23 (35.4) |
| Multicenter | 14 (21.5) |
| Single center | 17 (26.2) |
| NR/unclear | 11 (16.9) |
| Continents | |
| Africa | 6 (9.2) |
| Asia | 6 (9.2) |
| Oceania | 6 (9.2) |
| Europe | 54 (83.1) |
| North America | 12 (18.5) |
| South America | 1 (1.5) |
| Study design | |
| RCTs | 64 (98.5) |
| Parallel RCTs | 41 (64.1) |
| Cross-over RCTs | 23 (35.9) |
| Non-RCT | 1 (1.5) |
| Year of publication (range) | 1984 to 2018 |
| Treatment period (range) | 0.14 weeks to 104.36 weeks |
| Sample size (range) | 8 to 749 |
| Patient characteristics | |
| Mean % female (range) | 40.0 (0 to 100) |
| Mean age, years (range) | 38.4 (22.8 to 54.0) |
| Mean A1c, % (range) | 8.0 (6.9 to 10.2) |
| Mean BMI, kg/m2 (range) | 24.9 (21.8 to 28.0) |
| Mean duration of T1DM, years (range) | 16.0 (8.1 to 26.9) |
| Intervention characteristics | |
| Basal class (basal insulin origin), basal frequency | |
| Intermediate-acting (animal and human) [NPH], bid | 1 (1.4) |
| Intermediate-acting (animal) [NPH], NR | 1 (1.4) |
| Intermediate-acting (human) [NPH], NR | 2 (2.9) |
| Intermediate-acting (animal) [NPH], od | 1 (1.4) |
| Intermediate-acting (human) [NPH], od | 13 (18.6) |
| Intermediate-acting (human) [NPH], bid | 21 (30) |
| Intermediate-acting (human) [NPH], qid | 2 (2.9) |
| Intermediate-acting (animal) [Lente], NR | 1 (1.4) |
| Intermediate-acting (human) [Lente], NR | 2 (2.9) |
| Intermediate-acting (animal) [Lente], bid | 2 (2.9) |
| Intermediate-acting (human) [Lente], bid | 3 (4.3) |
| Long-acting (human) [Detemir], od | 15 (21.4) |
| Long-acting (human) [Detemir], bid | 16 (22.9) |
| Long-acting (human) [Glargine], od | 42 (60) |
| Long-acting (human) [Glargine], bid | 2 (2.9) |
| Long-acting (biosimilar) [Glargine], od | 6 (4.3) |
| Ultra-long-acting (human) [Degludec], od | 17 (24.3) |
| Basal class | |
| Intermediate-acting | 46 (70.8) |
| Long-acting | 78 (120) |
| Ultra-long-acting | 17 (26.2) |
| Basal insulin type | |
| NPH | 38 (58.5) |
| Lente | 8 (12.3) |
| Glargine | 50 (76.9) |
| Detemir | 28 (43.1) |
| Degludec | 17 (26.2) |
| Outcome characteristics | |
| A1c | 51 (72.9) |
| AEs | 46 (65.7) |
| FPG | 42 (60) |
| Hypoglycemia | 61 (87.1) |
| LY | 3 (4.3) |
| Mortality | 17 (24.3) |
| QALY | 5 (7.1) |
| Quality of life | 10 (14.3) |
| Vascular complications | 16 (22.9) |
| Weight change | 58 (82.9) |
Abbreviations: A1c, glycated hemoglobin; AEs, adverse events; bid, twice a day; BMI, body mass index; FPG, fasting plasma glucose; LY, life years; NPH, neutral protamine Hagedorn; NR, not reported; od, once a day; qid, four times a day; QALY, quality-adjusted life years; RCT, randomized controlled trial; T1DM, Type 1 diabetes mellitus