The Evaluation of the Effects of Structured Carbohydrate-Counting Education on Glycemic Control, Insulin Requirements, Anthropometric Measurements, and Dietary Intake in Adults With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glycemic control/CGM metrics
研究概览
简要总结
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed at baseline and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.
详细描述
This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed before and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-65 years Diagnosis of type 1 diabetes for at least 1 year Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion HbA1c ≤10% Body mass index (BMI) 19-30 kg/m² C-peptide <0.8 ng/mL Use of a continuous glucose monitoring system No communication difficulties No previous knowledge of carbohydrate counting and willingness to receive carbohydrate-counting education -
排除标准
- •Gastroparesis Diabetic nephropathy Pregnancy Celiac disease Eating disorder Food allergy Gastrointestinal disease or malabsorption Inability to adhere to the study protocol Withdrawal of consent Discontinuation of continuous glucose monitoring during follow-up
研究组 & 干预措施
Individualized Carbohydrate Counting Education
Participants took part in a 12-week individualized carbohydrate-counting training program delivered by a dietitian. The intervention covered carbohydrate counting, the estimation of food and carbohydrate content, and the individualized determination and adjustment of meal-specific insulin-to-carbohydrate ratios. Participants were assessed at baseline and at the end of the 12-week period.
干预措施: Carbohydrate counting education (Behavioral)
结局指标
主要结局
Glycemic control/CGM metrics
时间窗: 12 weeks
Glycemic control/CGM metrics
时间窗: 12 week
Time in range (TIR) was assessed using continuous glucose monitoring (CGM) data and defined as the percentage of time that sensor glucose values remained within the target range of 70-180 mg/dL. The change in TIR was evaluated from baseline to the end of the 12-week intervention.
Change in Time in Range (70-180 mg/dL)
时间窗: Baseline and 12 weeks
Time in range (TIR) was assessed using continuous glucose monitoring (CGM) data and defined as the percentage of time that sensor glucose values were within the target range of 70-180 mg/dL. Change in TIR was evaluated from baseline to the end of the 12-week intervention.
次要结局
- Change in Glycemic Variability(Baseline and 12 weeks)
- Change in Laboratory-Measured HbA1c(Baseline and 12 weeks)