Gestational diabetes & diabetes in pregnancy
Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial
Primary result · Time in target range (averaged over four time periods)Result — go to the resultAdjusted mean difference 1.88 percentage points 95% CI −0.82 to 4.58Authors' conclusion
In pregnant women starting with tighter glycaemic control, AHCL therapy did not improve overall time in target range but improved overnight time in target range, reduced time below range, and improved treatment satisfaction. These data suggest that the MiniMed 780G can be safely used in pregnancy and provides some additional benefits compared with standard insulin therapy; however, it will be important to refine the algorithm to better align with pregnancy requirements.
Study context
- Population
- Pregnant women aged 18–45 years with T1D, randomised at a median of 10.1 (IQR 8.6–11.6) weeks of gestation; 12 hospitals (11 in Belgium, one in the Netherlands)randomly assigned
- Participants
- 95 women
- Comparison
- Advanced hybrid closed loop (AHCL) therapy vs standard insulin therapy
- AHCL therapyn = 46
- Standard insulin therapyn = 49reference
- Primary endpoint
- Proportion of time in pregnancy-specific target glucose range (3.5-7.8 mmol/L) by continuous glucose monitoring (CGM)
- Follow-up
- 14-17 weeks, 20-23 weeks, 26-29 weeks, and 33-36 weeks
Methodological detailsparallel-group, open-label, multicentre, minimisation
- Parallel-group
- Open-label
- Multicentre
- Minimisation
Primary result
As reported in the abstract
Adjusted mean difference
1.88 percentage points
95% CI −0.82 to 4.58
P = 0.17
By group
Secondary outcomes
| Outcome | Adjusted mean difference (percentage points) (95% CI) | P value | |
|---|---|---|---|
| Overnight time in target range | 6.58 (2.31–10.85) | P = 0.0026 | |
| Time below range (<3.5 mmol/L) overall | −1.34 (−2.19 to −0.49) | P = 0.0020 | |
| Time below range (<3.5 mmol/L) overnight | −1.86 (−2.90 to −0.81) | P = 0.0005 | |
| −5051015Difference, percentage points (linear scale) |
Treatment satisfaction
- Higher treatment satisfaction with AHCL therapy
Safety
- No unanticipated safety events occurred with AHCL therapy
Original publication
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