ArticleDiabetes technology & therapeutics2015
Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials.
Article in Diabetes technology & therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Interactive Remote Patient Monitoring Devices for Managing Chronic Health Conditions: Systematic Review and Meta-analysis.Journal of medical Internet research · 2022Pooled it
- Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial.Lancet (London, England) · 2019Trial
- Randomized, double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3.Diabetes, obesity & metabolism · 2016Trial
- Randomized double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 2 diabetes: IMAGINE 4.Diabetes, obesity & metabolism · 2016Trial
- Reduced nocturnal hypoglycaemia with basal insulin peglispro compared with insulin glargine: pooled analyses of five randomized controlled trials.Diabetes, obesity & metabolism · 2016Trial
- Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trials.NPJ digital medicine · 2025Review
- Exploring the Role of Time in Diabetes Self-Management: A Scoping Review of Challenges, Intervention Strategies, and Implications for Clinical Care.Diabetes spectrum : a publication of the American Diabetes Association · 2025Article
- The Key Digital Tool Features of Complex Telehealth Interventions Used for Type 2 Diabetes Self-Management and Monitoring With Health Professional Involvement: Scoping Review.JMIR medical informatics · 2024Article
- Fabry App: the value of a portable technology in recording day-to-day patient monitored information in patients with Fabry disease.Orphanet journal of rare diseases · 2024Article
- Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management.Arthritis research & therapy · 2021Article
- Relationship of Glucose Variability With Glycated Hemoglobin and Daily Mean Glucose: A Post Hoc Analysis of Data From 5 Phase 3 Studies.Journal of diabetes science and technology · 2018Article
- Insulin therapy for type 2 diabetes - are we there yet? The d-Nav® story.Clinical diabetes and endocrinology · 2018Article
- Integrating Patient-Generated Health Data Into Clinical Care Settings or Clinical Decision-Making: Lessons Learned From Project HealthDesign.JMIR human factors · 2016Article
- Cost-Effectiveness Analysis of d-Nav for People with Diabetes at High Risk of Neuropathic Foot Ulcers.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient-investigator interactions during intensive insulin management in diabetes clinical trials. MATERIALS AND
methodsWe implemented a customized electronic communication system featuring an e-diary and a Web portal in three global, randomized, controlled Phase 3 clinical trials testing basal insulin peglispro compared with insulin glargine, both combined with prandial insulin lispro, in patients with type 1 or type 2 diabetes mellitus (T1DM and T2DM, respectively). We collected data during 28 weeks of study e-diary use for the report.
resultsPatients (n=2,938) in 31 countries used e-diaries to transmit 2,439,087 blood glucose (BG) values, 96% of which were associated by the patient with a protocol time point during the 72-h response window. Of 208,192 hypoglycemia events captured, 96% had a BG value, and 95% had treatments and outcomes entered by patients within the 72-h window. Patients recorded administration of 1,964,477 insulin doses; 93% of basal insulin doses were adherent with the investigator prescription. Investigators adjusted 13 basal and 92 bolus insulin prescriptions per patient-year using the e-diary system. After 26 weeks of treatment and e-diary use in the combined study arms, hemoglobin A1c values decreased by 0.6% or 1.6% and fasting BG decreased by 7.8 or 28 mg/dL in patients with T1DM or T2DM, respectively.
conclusionsThe e-diary system enabled comprehensive data collection and facilitated communication between investigators and patients for intensive insulin management in three global clinical trials testing basal insulins.
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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.