Trial reportDiabetes care2023
Efficacy of a Connected Insulin Pen Cap in People With Noncontrolled Type 1 Diabetes: A Multicenter Randomized Clinical Trial.
Trial report in Diabetes care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Effect of digital interventions on adherence to the management of type 1 diabetes mellitus patients: a systematic review.BMC endocrine disorders · 2025Pooled it
- International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024: Diabetes Technologies - Insulin Delivery.Hormone research in paediatrics · 2024Guideline
- Analysis of glycaemic control and treatment satisfaction with a connected smart pen cap in adults with type 1 diabetes: a randomised, open-label, parallel-group trial.Diabetologia · 2026Trial
- Insulin pens and the digital ecosystem.Diabetologia · 2026Review
- Effectiveness of the Stage 4 Smart Insulin Pen DIA:CONN P8 for Glycemic Control in a Real-World Setting.Diabetes & metabolism journal · 2026Article
- Improvement in insulin injection timing and glucometrics using a connected insulin cap: theFrontiers in endocrinology · 2026Observational
- Artificial intelligence-driven therapeutics for disease modification in type 1 diabetes: a digital public health and clinical translation framework.Frontiers in public health · 2026Review
- 7. Diabetes Technology: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- Insights into the effective use of the Smart MDI system: Data from the first 1852 type 1 diabetes users.Diabetic medicine : a journal of the British Diabetic Association · 2025Article
- Article
- Glycaemic control after connected insulin pen initiation in people living with diabetes: Results from a real-world setting.Diabetes, obesity & metabolism · 2025Observational
- Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis.The Journal of clinical endocrinology and metabolism · 2025Observational
- 2025 Clinical Practice Guidelines for Diabetes Management in Korea: Recommendation of the Korean Diabetes Association.Diabetes & metabolism journal · 2025Article
- Characterizing insulin dosing behaviour and glycaemic excursions: Development of metrics using connected insulin pen and continuous glucose monitoring.Diabetes, obesity & metabolism · 2025Observational
- 7. Diabetes Technology: Standards of Care in Diabetes-2025.Diabetes care · 2025Review
- Use of diabetes technology in children.Diabetologia · 2024Review
- Nocturnal Glucose Profile According to Timing of Dinner Rapid Insulin and Basal and Rapid Insulin Type: AnBiomedicines · 2024Article
- Association Between Treatment Adherence and Continuous Glucose Monitoring Outcomes in People With Diabetes Using Smart Insulin Pens in a Real-World Setting.Diabetes care · 2024Article
- Connected Insulin Pens and Caps: An Expert's Recommendation from the Area of Diabetes of the Spanish Endocrinology and Nutrition Society (SEEN).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Article
- First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis.Clinical diabetes : a publication of the American Diabetes Association · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the efficacy of the insulin pen cap Insulclock on improving glycemic control, treatment adherence, and user satisfaction in people with type 1 diabetes. RESEARCH DESIGN AND
methodsThis multicenter, open-label, randomized controlled trial comprised a 4-week run-in phase and a 6-week double-arm phase in which participants were randomly assigned into an active or masked mode.
resultsFifty-five participants were evaluable (active group, n = 26, masked group, n = 29). The increase in time in range was higher in the active versus masked group (5.2% vs. -0.8%; P = 0.016). The active group showed a higher reduction in mean glucose, glucose management indicator, time above range, and high blood glucose index. On-time insulin doses increased in the active group and decreased in the masked group.
conclusionsInsulclock system use was associated with improved glycemic control, glycemic variability, hyperglycemia risk, and treatment adherence in people with uncontrolled type 1 diabetes.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.