Summary of findings 4. Summary of findings: insulin degludec versus insulin detemir.
Insulin degludec compared with insulin detemir for T1DM | ||||||
Patients people with T1DM Settings: outpatients Intervention: insulin degludec Comparison: insulin detemir | ||||||
Outcomes | Insulin detemir | Insulin degludec | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments |
All‐cause mortality Follow‐up: 26 weeks |
See comment | 802 (2) | ⊕⊕⊝⊝ lowa | No participant died 1 study included adults, 1 study included children |
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Health‐related quality of life Scale: Short‐Form 36 version 2 (higher values mean better health‐related quality of life) Follow‐up: 26 weeks |
Physical health score: the mean score in the insulin detemir group was 52.5 Mental health score: the mean score in the insulin detemir group was 52.5 |
Physical health score: the mean score in the insulin degludec group was 0.60 points lower (1.83 points lower to 0.63 points higher) Mental health score: the mean score in the insulin degludec group was 3.00 points lower (4.44 points lower to 1.56 points lower) |
— | 454 (1) | ⊕⊕⊝⊝ lowb | Physical health score: MID is 2‐3 points Mental health score: MID is 3 points Study included adults |
Severe hypoglycaemia (n/N) Definition: hypoglycaemia requiring third party assistance (Davies 2014) or altered mental status and cannot assist in their own care, is semiconscious or unconscious, or in a coma ± convulsions and may require parenteral therapy (glucagon or iv glucose) (BEGIN Young) Follow‐up: 26 weeks |
122 per 1000 | 143 per 1000 (99 to 207) | RR 1.17 (0.81 to 1.69) | 802 (2) | ⊕⊕⊝⊝ lowc | 1 study included adults, 1 study included children (the test for subgroup differences did not indicate interaction) |
Non‐fatal myocardial infarction/stroke Definition: non‐fatal myocardial infarction/stroke Follow‐up: 26 weeks |
See comment | 453 (1) | ⊕⊕⊝⊝ lowa | No participant experienced a non‐fatal myocardial infarction or stroke Study included adults |
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Severe nocturnal hypoglycaemia (n/N) Definition: severe hypoglycaemia occurring 00:01‐05:59 (Davies 2014) or 23:00‐07:00 (BEGIN Young) Follow‐up: 26 weeks |
31 per 1000 | 34 per 1000 (16 to 75) | RR 1.12 (0.51 to 2.46) | 802 (2) | ⊕⊕⊝⊝ lowc | 1 study included children, 1 study included adults (the test for subgroup differences did not indicate interaction) |
Serious adverse events (n/N) Follow‐up: 26 weeks |
73 per 1000 | 92 per 1000 (56 to 150) | RR 1.25 (0.76 to 2.05) | 802 (2) | ⊕⊕⊝⊝ lowc | 1 study included children, 1 study included adults (the test for subgroup differences did not indicate interaction) |
HbA1c (%) Follow‐up: 26 weeks |
The mean HbA1c in the insulin glargine groups was 7.3% | The mean HbA1c in the insulin detemir groups was 0.05% lower (0.1% lower to 0.2% higher) | — | 802 (2) | ⊕⊕⊝⊝ lowc | 1 study included children, 1 study included adults (the test for subgroup differences did not indicate interaction) |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). a.m.: ante meridiem; CI: confidence interval; HbA1c: glycosylated haemoglobin A1c; iv: intravenous; MID: minimal important difference; n/N: number of people experiencing an event; p.m.: post meridiem; RR: risk ratio; T1DM: type 1 diabetes mellitus. | ||||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. |
*Assumed risk was derived from the event rates in the comparator groups. aDowngraded by two levels because of indirectness (insufficient time frame) and imprecision (few studies) ‐ see Appendix 4. bDowngraded by two levels because of overall risk of bias ('some concerns') and imprecision (few studies) ‐ see Appendix 4. cDowngraded by two levels because of serious imprecision (CI consistent with benefit and harm, few studies) ‐ see Appendix 4.