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Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes 22 मशीन लर्निंग जीवन शैली व्यक्तिगत उपचार

समाप्त
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT03053518 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो प्रकार2 मधुमेह से जुड़ा हुआ है। परीक्षण वर्तमान में समाप्त चल रहा है। इसकी शुरुआत 30 जून 2017 को हुई थी, और इसमें कुल 22 प्रतिभागियों के नामांकन की योजना है। NYU Langone Health इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 जनवरी 2018 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 21 सितंबर 2020 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage, single-group feeding study in 20 individuals, including 10 participants managed with lifestyle alone, and 10 managed with lifestyle plus metformin.
विस्तृत विवरण
The PNP algorithm, which uses a machine learning algorithm to predict postprandial glycemic, may be efficacious for generating tailored dietary advice to moderate the participant's glycemic response to food.
आधिकारिक शीर्षक

Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes

स्वास्थ्य स्थितियां
प्रकार2 मधुमेह
अन्य अध्ययन आईडी
  • 16-01059
NCT नंबर
NCT03053518
अध्ययन प्रारंभ तिथि (वास्तविक)
2017-06-30
अंतिम अद्यतन प्रकाशित
2020-09-21
अध्ययन की समाप्ति तिथि (अनुमानित)
2018-01-31
नामांकन (अनुमानित)
22
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
समाप्त
प्रमुख शब्द
Type 2 Diabetes
Hyperglycemia
Personal Nutrition Project
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
गैर-यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
सक्रिय तुलना समूहLife Style
जीवनशैली
Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods.
प्रयोगात्मकLife Style + Metformin
Abbott Freestyle Libre Pro
A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.
जीवनशैली
Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Observed Incremental Area Under the Curve (iAUCobs)
Observed incremental area under the curve (iAUCobs) at 2 hours following each meal and snack will be evaluated via CGM using the Abbott Freestyle Libre Pro, which captures interstitial glucose every 5 minutes. A sensor is inserted into the participant's upper arm. Participants will be blinded to glycemia tracings.
2 Hours
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
21 Years
अध्ययन के लिए पात्र लिंग
सभी
  • Age >21 years to <70 years
  • Diagnosed with T2DM within 2 years with an HbA1c<7%
  • Diabetes management by metformin or lifestyle intervention
  • Fasting C-peptide ≥ 0.5 mg/mL (0.17 nmol/L) (to exclude those for whom hyperglycemic exposure is driven by β-cell failure rather than dietary behaviors, as well as those requiring escalation of the medication regime)
  • Ownership a smart phone and are willing to use it to monitor multiple factors influencing glycemic response to glycemia (e.g., sleep, physical activity, diet, stress, medication, and hunger)

  • are unable or unwilling to provide informed consent;
  • are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
  • are pregnant, are currently trying to become pregnant, or who become pregnant during the study
  • are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
  • have had or are planning to have bariatric surgery during the study
  • have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
  • those with an active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study;
  • those who use acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects CGM accuracy)39
  • immunosuppressive drugs within three months prior to participation and
  • Chronically active inflammatory or neoplastic disease in the three years prior to enrollment.
  • Patients with known food allergy.
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