Analysis of glycaemic control with a connected smart pen cap in adults with type 1 diabetes: a randomised, open-label, parallel-group trial
An erratum to this article was published (Diabetologia, Sep 2026 ↗)
Primary result · TAR >13.9 mmol/lResult — go to the resultMean difference −4.8 percentage points 95% CI −9.5 to −0.1Authors' conclusion
In routine clinical care, use of a connected pen cap reduced severe hyperglycaemia, glycaemic variability and hypoglycaemia avoidance behaviours in adults with type 1 diabetes and suboptimal glycaemic management, without affecting treatment satisfaction. These findings support the integration of low-burden, data-driven tools into public diabetes care. Larger and longer trials should evaluate the durability and cost-effectiveness of these interventions.
Study context
- Population
- Adults with T1D on MDI with suboptimal glycaemic management (baseline TAR >10.0 mmol/l >25%), European public hospital41 in ITT analysis
- Participants
- 42 adults
- Comparison
- Connected insulin pen cap vs identical disconnected cap
- Connected capn = 21
- Disconnectedn = 21reference
- Primary endpoint
- TAR at two thresholds (>10.0 mmol/l and >13.9 mmol/l), from isCGM downloads
- Follow-up
- 8 weeks
Methodological detailsinvestigator-initiated, open-label, parallel-group, single-centre, Allocation by opaque sealed envelopes; no masking, One withdrew before baseline
- Investigator-initiated
- Open-label
- Parallel-group
- Single-centre
- Allocation by opaque sealed envelopes; no masking
- One withdrew before baseline
Primary result
TAR >13.9 mmol/l
Mean difference
−4.8 percentage points
95% CI −9.5 to −0.1
P = 0.045
As reported in the abstract
Secondary outcomes
| Outcome | Estimate | P value |
|---|---|---|
| Glucose SD · 8 weeksReduced with connected cap · ITT analysis | −0.35 mmol/l (95% CI −0.64 to −0.06) | P = 0.018 |
HbA1c · 8 weeks
- HbA1c showed a borderline reduction
- −3.5 mmol/mol (−0.32%) (95% CI −7.1, 0.0 mmol/mol; −0.65, 0.00%; p=0.050)
TIR among adherent users
- Absolute increase in TIR among adherent users
- 8%
- Per-protocol analyses
Treatment satisfaction
- No between-group differences in treatment satisfaction scores
Hypoglycaemia fear survey avoidance behaviours
- Avoidance behaviours significantly decreased in the treatment group (95% CI −4.45, −0.43; p=0.019)
- β=−2.44
Safety
- Adverse events or device-related serious adverse events
- 0
Original publication
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