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临床试验/NCT05443204
NCT05443204Unknown不适用

Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes and Oral Supplements: Standard Formula vs Specific Formula for Diabetes

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
MFG discharge - mean interstitial glucose

研究概览

简要总结

Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)

详细描述

In people with malnutrition and diabetes who require oral supplementation, there is no evidence clear when choosing a specific supplement for diabetes or a standard supplement. To date, there are no studies evaluating flash glucose monitoring in people with DM2 with supplements, nor studies comparing formulas specific for diabetes with standard formulas. Patients with type 2 diabetes, malnutrition and requiring oral nutritional supplements for 3 months will be included in the study.

A standard supplement (minimum 2 per day) will be prescribed for 2 weeks, an installation of the MFG system indicating that the scans are performed at start up, at the time and two hours after taking the oral supplement at home, as it doesn't happen anymore 8 hours without scanning to avoid losing information. After 14 days participants will go to consultation to download MFG data, assess acute response after taking of the supplement in the presence of health personnel (every 15 minutes for 4 hours). Investigators will change the sensor and nutritional supplement to a specific diabetes formula, after 14 days participants will come for MFG data download and to assess acute response after taking the supplement in the presence of healthcare personnel.

The results of the study will allow us to carry out a more appropriate treatment in this profile of patients, which is increasingly prevalent in our consultations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with DM2 under follow-up by the Clinical Nutrition and Dietetics Unit (UNCYD) who present malnutrition or are at risk of malnutrition and require oral nutritional supplements, for a minimum estimated period of 3 months.

排除标准

  • Patients with DM1, steroid diabetes, pancreatic diabetes, DM2 treated with rapid insulin, glomerular filtration rate less than 30 mL/min/1.73m2, intolerance to the product, gastrectomy or gastroparesis.
  • Patients who do not sign the consent informed.

结局指标

主要结局

MFG discharge - mean interstitial glucose

时间窗: During 14 days after taking the supplement

Interstitial glucose measured in mg/dl

MFG discharge - hyperglycaemia

时间窗: During 14 days after taking the supplement

hyperglycaemia measured in mg/dl

MFG discharge - hypoglycaemia

时间窗: During 14 days after taking the supplement

hypoglycaemia measured in mg/dl

MFG discharge - GMI

时间窗: During 14 days after taking the supplement

Measured in number of scans per day

MFG discharge - hypoglycaemic events

时间窗: During 14 days after taking the supplement

Measured in number and duration per day

次要结局

  • Postprandial glucose intersticial monitoringdiabetes specific supplement(During the 4 hours after taking standard formula and the one specific for diabetes)

研究者

发起方
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
申办方类型
Other
责任方
Sponsor

研究点 (2)

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