Summary of findings 4. Summary of findings: NPH insulin versus glargine for CFRD.
NPH insulin versus glargine for CFRD | ||||||
Patient or population: adults with CFRD and fasting hyperglycemia Settings: home Intervention: NPH insulin (individually dosed based on insulin to carbohydrate ratio) at bedtime Comparison: insulin glargine given at bedtime | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Insulin glargine | NPH insulin | |||||
HbA1c | This outcome was not measured. | 1 study reported on fasting and 2‐hour post‐prandial glucose. There was no significant difference between groups for either measure, MD 10.00 mg/dL (95% CI ‐12.86 to 32.86) and MD 8.00 mg/dL (95% CI ‐10.07 to 26.07) respectively (Grover 2008). | ||||
FEV1 % predicted | This outcome was not measured. | |||||
FVC % predicted | This outcome was not measured. | |||||
BMI kg/m² | This outcome was not measured. | BMI was not reported for this comparison. The Grover study did however report on mean change in: weight, MD ‐1.00 kg (95% CI ‐2.39 to 0.39); fat mass, MD ‐0.30 kg (95% CI ‐1.41 to 0.81); and lean mass, MD ‐0.20 kg (95% CI ‐0.75 to 0.35). None of the results showed any significant difference between NPH insulin and glargine (Grover 2008). | ||||
Hypoglycemia mean number of events per participant Follow‐up: 12 weeks |
The mean number of hypoglycaemic events in the control group was 6 per participant. | The mean number of hypoglycaemic events in the intervention group was 1 event lower (4 events lower to 2 events higher). | MD ‐1.00 (‐3.77 to 1.77) | 19 (1) | ⊕⊝⊝⊝ very lowa,b | |
*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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMI: body mass index; CFRD: cystic fibrosis‐related diabetes; CI: confidence interval; HbA1c: glycated hemoglobin; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; MD: mean difference; NPH: neutral protamine hagedorn. | ||||||
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. |
a. Downgraded twice for risk of bias. There was an unclear or high risk of bias across all domains for this study.
b. Downgraded once due to imprecision caused by small sample size and low event rates.