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临床试验/NCT01791907
NCT01791907已完成不适用

Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes

Göteborg University0 个研究点目标入组 181 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
181
主要终点
HbA1c

研究概览

简要总结

Type 1 diabetes (T1DM) is a chronic disease that affects approximately 10% of all diabetes patients in the world. Diabetes a serious disease in which life expectancy is reduced, largely due to increased mortality from kidney disease and cardiovascular (CVD) disease. Poor glycemic control also results in eye and nerve damage, and psychosocial stress. Good metabolic control, e.g. normalized hemoglobin levels (HbA1c) and normal blood lipids, reduces the risk of eye, kidney, nerve, and vascular damage. Proper nutrition can normalize blood sugar levels, improve blood lipids and prolong life in people with diabetes, according to Swedish Council on Health Technology Assessment (SBU).

Dietary treatment is therefore seen as pivotal in the treatment of diabetes. This project aims to evaluate two methods of structured training in patients with type 1 diabetes:

  1. A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
  2. A new, structured education for heart healthy food choices and low glycemic index in type 1 diabetes. The education is called "My Wellness-LADDER" (Lifelong Adult Diet & Diabetes Education Resource) and it is specifically designed to provide high long-term adherence through improved empowerment and transformative life style change.

The methods are compared with regular routine (control group).

This is a randomized controlled trial with three intervention groups 1) Healthy food choices with a low glycemic index, 2) carbohydrate counting, and 3) regular routine. Follow-up period is 1 year. Eight Swedish specialist clinics are participating and 24 patients at each clinic are to be enrolled.

The hypotheses is that structured group education on heart healthy food choices and low glycemic index provide the same improvement in glycemic control and quality of life as advanced carbohydrate counting in T1DM, as compared to regular routine. An additional hypotheses is that structured education on healthy food choices and low glycemic index leads to larger CVD risk factor reductions in T1DM compared to carbohydrate counting and regular routine and that structured education on healthy food choices and low glycemic index lead to more heart healthy food choices in T1DM compared to carbohydrate counting and regular routine. Lastly, the hypotheses is that structured education on healthy food choices and low glycemic index lead is more cost effective in T1DM compared to carbohydrate counting and regular routine.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having type 1 diabetes
  • Diabetes duration > 3 years
  • Age 20-70 years
  • BMI <35 (kg/m2)
  • Multiple dose injection (MDI) therapy
  • HbA1c 57-78 mmol/mol
  • Being healthy other than diabetes
  • Autonomous accommodation and having influence over one's own food choices.
  • Have given informed consent to participate in the study, as well as having the ability of oral and written communication in Swedish.

排除标准

  • Nephropathy (dU albumin> 300 mg / d)
  • Retinopathy (grade> 2)
  • Foot ulcers
  • Gastroparesis
  • Difficulties visiting the hospital
  • Current or planned pregnancy during the study period
  • ≥ 14 days fast during the study period
  • Having partaken in education in carbohydrate counting (≥ 4 hours) in the last two years
  • No computer access

研究组 & 干预措施

Structured education in carbohydrate counting

Experimental

A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)

干预措施: Structured education in carbohydrate counting (Behavioral)

Structured education in healthy food choices and low GI

Experimental

A new, structured education for heart healthy food choices and low glycemic index in type 1 diabetes. The education is called "My Wellness-LADDER" (Lifelong Adult Diet & Diabetes Education Resource) and it is specifically designed to provide high long-term adherence through improved empowerment and transformative life style change.

干预措施: Structured education in healthy food choices and low glycemic index (Behavioral)

Regular routine

No Intervention

结局指标

主要结局

HbA1c

时间窗: 1 year

The primary outcome measure is to detect a clinically significant difference in HbA1c (= 4.2 mmol / mol) between the three treatment arms

次要结局

  • Quality of life(1 year)
  • Hypoglycemia(1 year)
  • Food choices(1 year)
  • Health economics(1 year)
  • CVD risk factors(1 year)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

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