Smart insulin pens with integrated bolus calculator vs tracking-only connected insulin pens in adults with diabetes on multiple daily injections: a multicentre randomised controlled trial
Primary result · Change in HbA1cResult — go to the resultAdjusted mean difference −3.39 mmol/mol 95% CI −6.45 to −0.22Authors' conclusion
In this randomised controlled trial of adults with suboptimally controlled diabetes on MDI, SIP with bolus calculator significantly improved glycaemic management and dosing behaviour compared with tracking-only CIP.
Study context
- Population
- Adults aged 19–74 years with type 1 or type 2 diabetes on MDI therapy with HbA1c 58–108 mmol/mol (7.5–12.0%), nine medical centres in South Korea; all participants used continuous glucose monitoring (CGM)randomised, 116 included in the modified intention-to-treat analysis
- Participants
- 120 adults
- Comparison
- SIP with bolus calculator vs tracking-only CIP for 12 weeks
- SIPn = 60
- Tracking-only CIPn = 60
- Primary endpoint
- Change in HbA1c
- Follow-up
- Baseline to week 12
Methodological detailscomputer-generated block randomisation stratified by diabetes type, 1:1
- Computer-generated block randomisation stratified by diabetes type
- 1:1
Primary result
As reported in the abstract
Adjusted mean difference
−3.39 mmol/mol
95% CI −6.45 to −0.22
P = 0.036
SIPvs tracking-only CIP
adjusted mean difference −3.39 mmol/mol (95% CI −6.45 to −0.22); P = 0.036
Secondary outcomes
| Outcome | Adjusted mean difference (95% CI) | P value | |
|---|---|---|---|
| Time in range (3.9-10.0 mmol/l)Improved significantly with SIP; 57.2% vs 50.8% | 6.58% (1.52%–11.64%) | P = 0.012 | |
| −5051015Difference (linear scale) |
Missed bolus doses · fewer with SIP
P = 0.020
Bolus frequency · higher with SIP
P = 0.011
Safety
- No severe hypoglycaemia or diabetic ketoacidosis occurred in either group
Original publication
Smart insulin pens with integrated bolus calculator vs tracking-only connected insulin pens in adults with diabetes on multiple daily injections: a multicentre randomised controlled trial. Diabetologia. Published 14 November 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →