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. 2021 Mar 4;2021(3):CD013498. doi: 10.1002/14651858.CD013498.pub2

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
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
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.