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临床试验/NCT02637154
NCT02637154Unknown不适用

The Effect of Motivational Interview and Intensive Education on HbA1C Values and Glucose Variability in Adolescents With Poorly Controlled Type 1 Diabetes

Helsinki University Central Hospital5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
5
主要终点
Change in HbA1C values (mmol/mol)

研究概览

简要总结

This study investigates the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients.

In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.

详细描述

Background Type 1 diabetes (T1D) patients with optimal glycemic control suffer markedly less from long term diabetic complications than those with poor control. Increased glycohemoglobin (HbA1C) levels predict the complication risk. The development of diabetic complications seems to accelerate during puberty, and poor metabolic control during adolescence or young adulthood markedly increases the incidence of micro- or macrovascular complications during subsequent years. On the other hand, intensive treatment during adolescence has been reported to reduce the risk of microvascular complications, even if the control later on becomes poorer. This implicates that interventions targeting at improved glycemic control during adolescence probably have sustained beneficial effects on the overall morbidity in patients T1D.

The glycemic control of Finnish adolescents with T1D is poor. Insulin resistance and impaired metabolic control are common problems. Treatment of the disease during puberty can be complicated and particularly treatment adherence often declines in youth. Inexpensive and easily adoptable methods for clinicians are needed to overcome treatment problems faced with adolescent patients.

At present, there are no generally recommended approaches for clinicians to apply in order to motivate adolescents with poor glycemic control towards better treatment adherence. To this end, motivational interviewing (MI) has been used to an increasing degree in health care professionals in the treatment of variety of disorders and behavioral problems, such as alcohol and drug problems, gambling, and cardiovascular diseases. Motivational interviewing is a counseling approach designed to facilitate intrinsic motivation in the patient to change behavior. Significant body of evidence supports the view that MI improves commitment to care when added to other treatment. However, only a few studies have evaluated MI in the treatment of adolescent diabetes patients, with outcomes ranging from substantial benefit to neutral. MI is a promising approach for the treatment adolescent type 1 diabetics but there is a clear demand for methodologically solid studies.

Aims The aim of the present study is to investigate the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients. Secondarily, it will be investigated whether improved glycemic control is associated with improvements in vascular parameters, metabolic markers, markers of bone health and health related quality of life.

Hypothesis In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • the diagnosis of type 1 diabetes with at least 2 years duration and HbA1c > 75 mmol/mol on two consecutive visits, age 12-15.9 years and pubertal (Tanner) stage 2 or more at inclusion

排除标准

  • celiac disease with poor control; diagnosis of psychiatric disease; and other chronic disease requiring per oral glucocorticoid treatment

研究组 & 干预措施

Motivational Interviewing

Active Comparator

With 30 patients Motivational Interviewing method will be used during each visit

干预措施: Motivational Interviewing (Behavioral)

Standard Education

Active Comparator

With 30 patients Standard Education material will be used during each visit

干预措施: Standard Education (Behavioral)

结局指标

主要结局

Change in HbA1C values (mmol/mol)

时间窗: 12 months

HbA1c levels (mmol/mol) are measured in every visit (AfinionTM).

Change in glycaemic variability

时间窗: 12 months

Six days blinded continuous glucose monitoring (CGM) (iPro, Medtronic) will be performed at baseline and during the follow-up. Blinded CGM curves (0 and 12mo) will be analyzed to study effect on glycemic variability. Standard deviation (SD) of blood glucose values and mean amplitude of glycemic excursions (MAGE) will be used as parameters to define glycemic variability.

次要结局

  • Influence of changes in markers of inflammation (IL-6 - pg/ml)(12 months)
  • Influence of changes in marker of bone turnover: osteocalcin (ng/ml)(12 months)
  • Influence of changes in marker of bone turnover: aminoterminal telopeptide of type I collagen (INTP - ng/ml)(12 months)
  • Influence of changes in markers of vascular health (IMT)(12 months)
  • Influence of changes in markers of vascular health (PWV)(12 months)
  • Influence of changes in quality of life(12 months)
  • Influence of changes in markers of inflammation (high-sensitive-c-reactive-protein CRP - mg/l).(12 months)
  • Influence of changes in bone mineral density (BMD)(12 months)
  • Influence of changes in insulin-like-growth-factor IGF-I levels(12 months)
  • Influence of changes in vitamin D status (25-hydroxy-D) ng/ml(12 months)
  • Influence of changes in markers of bone turnover (serum aminoterminal propeptide of type I collagen (PINP - ng/ml)).(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mari Pulkkinen

MD, PhD

Helsinki University Central Hospital

研究点 (5)

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