IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non‐insulin Antihyperglycaemic ThErapy ( IMMEDIATE ): A randomized controlled trial
Authors' conclusion
The IMMEDIATE study has shown that among non-insulin-treated individuals with type 2 diabetes, use of isCGM is associated with an improvement in glycaemic outcomes.
Study context
- Population
- Adults with T2D using at least one non-insulin therapy, HbA1c ≥7.5% (≥58 mmol/mol); mean age 58 years, diabetes duration 10 years, mean HbA1c 8.6% (70 mmol/mol)randomized 1:1
- Participants
- 116 adults
- Comparison
- Intermittently scanned continuous glucose monitoring (isCGM) plus diabetes self-management education vs DSME alone
- Primary endpoint
- Percentage mean TIR in the final 2-week period, measured via blinded CGM
- Follow-up
- 16 weeks
Methodological detailsmultisite, open label, randomized 1:1, Enrolment 8 September 2020 to 24 December 2021
- Multisite
- Open label
- Randomized 1:1
- Enrolment 8 September 2020 to 24 December 2021
Primary result
Mean TIR
Difference
9.9 %
95% CI −17.3% to −2.5%
P < 0.01
As reported in the abstract
- Significantly greater mean time in range (TIR) with isCGM + DSME vs DSME
- 9.9% (2.4 hours)
Further findings
| Outcome | Difference (%) (95% CI) | P value | |
|---|---|---|---|
| Time above range · 16 weeks1.9 hours | 8.1 (0.5%–15.7%) | P = 0.037 | |
| Reduction in mean HbA1c · 16 weeksGreater reduction with isCGM + DSME; 3 mmol/mol | 0.3 (0%–0.7%) | P = 0.048 | |
| −1001020Difference, % (linear scale) |
| Outcome | Adjusted difference (95% CI) | P value | |
|---|---|---|---|
| Glucose monitoring satisfaction | −0.5 (−0.7 to −0.3) | P < 0.01 | |
| −1−0.500.5Difference (linear scale) |
Safety
Time below range and hypoglycaemia
- Time below range was low and not significantly different between groups
- Hypoglycaemic events were few in both groups
Original publication
IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non‐insulin Antihyperglycaemic ThErapy ( IMMEDIATE ): A randomized controlled trial. Diabetes Obes Metab. Published 11 January 2023. doi:10. 1111/ dom. 14949
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