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| ID | Type | Description | Link |
|---|---|---|---|
| HTA6446 | Other Identifier | Israel: Ministry of Health |
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The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PES Treatment | Experimental | Eligible patients will receive daily 5 min PES treatment for two weeks. Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) continuous glucose monitor (CGM) System |
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| Control | No Intervention | Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulator | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with hypoglycemia, and/ or adverse events that are related to treatment | Baseline through 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of minor side effects related to treatment | Baseline through 2 months | |
| Changes in mean interstitial glucose levels measured by CGM | Baseline, 1, 2, 5, and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf-Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27997608 | Derived | Catalogna M, Doenyas-Barak K, Sagi R, Abu-Hamad R, Nevo U, Ben-Jacob E, Efrati S. Effect of Peripheral Electrical Stimulation (PES) on Nocturnal Blood Glucose in Type 2 Diabetes: A Randomized Crossover Pilot Study. PLoS One. 2016 Dec 20;11(12):e0168805. doi: 10.1371/journal.pone.0168805. eCollection 2016. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014023 | Tissue Therapy, Historical |
| ID | Term |
|---|---|
| D009945 | Organotherapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D000529 | Complementary Therapies |
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| D004700 | Endocrine System Diseases |