ArticlePhysiological reports2015
Gastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial.
Article in Physiological reports, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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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.
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Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.Ophthalmology · 2016Trial
- Accelerating the development of bioelectronic medicine: overview and impact of the NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC) initiative.Bioelectronic medicine · 2026Review
- An ingestible, battery-free, tissue-adhering robotic interface for non-invasive and chronic electrostimulation of the gut.Nature communications · 2024Article
- Electroceuticals for Neurogastroenterology and Motility Disorders.Current gastroenterology reports · 2023Review
- Electroceuticals in the Gastrointestinal Tract.Trends in pharmacological sciences · 2020Review
- Bioelectric neuromodulation for gastrointestinal disorders: effectiveness and mechanisms.Nature reviews. Gastroenterology & hepatology · 2019Review
- Medical devices for the treatment of obesity.Nature reviews. Gastroenterology & hepatology · 2017Review
- Interventional treatment of obesity and diabetes: An interim report on gastric electrical stimulation.Reviews in endocrine & metabolic disorders · 2016Review
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Gastric electrical stimulation with the implanted DIAMOND device has been shown to improve glycemic control and decrease weight and systolic blood pressure in patients with type 2 diabetes inadequately controlled with oral antidiabetic agents. The objective of this study was to determine if device implantation alone (placebo effect) contributes to the long-term metabolic benefits of DIAMOND(®) meal-mediated gastric electrical stimulation in patients with type 2 diabetes. The study was a 48 week randomized, blinded, cross-over trial in university centers comparing glycemic improvement of DIAMOND(®) implanted patients with type 2 diabetic with no activation of the electrical stimulation (placebo) versus meal-mediated activation of the electrical signal. The endpoint was improvement in glycemic control (HbA1c) from baseline to 24 and 48 weeks. In period 1 (0-24 weeks), equal improvement in HbA1c occurred independent of whether the meal-mediated electrical stimulation was turned on or left off (HbA1c -0.80% and -0.85% [-8.8 and -9.0 mmol/mol]). The device placebo improvement proved to be transient as it was lost in period 2 (25-48 weeks). With electrical stimulation turned off, HbA1c returned toward baseline values (8.06 compared to 8.32%; 64.2 to 67.4 mmol/mol, P = 0.465). In contrast, turning the electrical stimulation on in period 2 sustained the decrease in HbA1c from baseline (-0.93%, -10.1mmol/mol, P = 0.001) observed in period 1. The results indicate that implantation of the DIAMOND device causes a transient improvement in HbA1c which is not sustained beyond 24 weeks. Meal-mediated electrical stimulation accounts for the significant improvement in HbA1c beyond 24 weeks.
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