Home 2000.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 2:1 |
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| Participants |
Inclusion criteria: adults, type 1 diabetes, diabetes duration ≥ 2 years, treated with insulin for 1 year, BMI < 35.0 kg/m2, HbA1c ≤ 11.0% Exclusion criteria: active proliferative retinopathy, nephropathy (serum creatinine > 150 mmol/L), recurrent severe hypoglycaemia, significant cardiovascular disease, systemic corticosteroid treatment, requiring > 1.4 U/(kg*day) insulin, pregnant, drug abuse Diagnostic criteria: type 1 diabetes according to WHO 1994 |
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| Interventions |
Number of study centres: 88 Treatment before study: insulin for 1 year Titration period: 6 months Insulin aspart vs. RHI (see Appendix 2) |
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| Outcomes |
Outcomes reported in abstract of publication: HbA1c, 8‐point blood glucose profiles, insulin dose, quality of life, hypoglycaemia, adverse events, treatment satisfaction Primary outcome(s): HbA1c Secondary outcome(s): ‐ Other outcome(s): hypoglycaemia (mild, severe, severe nocturnal), adverse events, quality of lifea, treatment satisfactionb |
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| Study details |
Run‐in period: 4 weeks Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: commercial (Novo Nordisk) Publication status: peer‐reviewed journal/full article |
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| Stated aim for study | Quote from publication: "To compare the efficacy of insulin aspart, a rapid‐acting insulin analogue, with that of unmodified human insulin on long‐term blood glucose control in Type 1 diabetes mellitus" | |
| Notes |
aResults only reported for the German subpopulations (published in Bott 2003) bOnly for participants in the UK |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Quote: "open‐labelled" Comment: no blinding |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote: "open‐labelled" Comment: no blinding |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Quote: "Safety haematology and biochemistry tests, drugs‐of‐abuse screen, HbA1c and serum lipids were measured using standard laboratory techniques at a central laboratory" Comment: HbA1c and other biochemical analyses performed at central laboratory ‐ likely to be blinded |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: not described, but considered unlikely |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: not described |
| Selective reporting (reporting bias) | Unclear risk | Comment: health‐related quality of life only mentioned in abstract |
| Other bias | High risk | Comment: discrepancies between tables and text for hypoglycaemia and HbA1c |