Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-Over Trial
Authors' conclusion
The results of this pilot study indicates that this smart insulin pen cap was effective in improving glycemic control with overall good satisfaction in insulin treated patients with type 2 diabetes. Future studies are needed to confirm its potential for improving care in insulin treated patients with diabetes.
Study context
- Population
- Insulin-treated patients with poorly controlled T2D on basal insulin ± oral agents, hemoglobin A1C (HbA1c) 7.0%–12.0%
- Participants
- 80 patients
- Comparison
- Smart insulin pen cap active phase (alarms/reminders) vs control/masked phase without feedback
Methodological detailspilot, cross-over
- Pilot
- Cross-over
Primary result
As reported in the abstract
Mean daily blood glucose
P < 0.01
Further findings
%
| Outcome | Active phase | Control/masked phase | P value |
|---|---|---|---|
| Reduction in HbA1c from baseline · 12 weeksGreater reduction with active phase | −0.98 | −0.72 | P = 0.006 |
Treatment adherence, insulin omission and insulin mistiming
- No significant differences in treatment adherence, insulin omission or insulin mistiming between phases
Treatment satisfaction (DTSQc)
- High patient satisfaction scores in both active and control phases
Residual (carryover) effect
- No residual effect after cross-over between active and control phases
Original publication
Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-Over Trial. J Diabetes Sci Technol. Published 22 July 2021. doi:10.
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