Interdisciplinary Care for the Patient With Type 2 Diabetes: Promoting Improvement in the Quality of Care at an Outpatient Level and Seeking Answers to Clinical Practice Questions - Reuse of Inputs and Placebo Intervention Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in glycemic control
研究概览
简要总结
A randomized clinical trial (RCT) will be carried out to compare the reuse or not of needles in patients with type 2 diabetes (T2DM) that use insulin. Two groups will be studied: a group that will not reuse the needles and a group that will reuse the needles five times. The aim of this study is to evaluate related outcomes such as bruises, infection, lipodystrophy, pain and glycemic control, whether or not to reuse insulin delivery needles in patients with T2DM who use insulin.
详细描述
Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease with increasing incidence worldwide. It is well demonstrated in the literature that adequate glycemic control can reduce the incidence of chronic complications. The Brazilian Ministry of Health must provide patients with diabetes with the necessary resources for optimal glycemic control. However, this supply is often not enough and the population ends up reusing needles and lancets. According to the Brazilian National Health Surveillance Agency (ANVISA) and the manufacturers, it is recommended to use the needle for insulin application only once, but a report from the Brazilian Society of Diabetes shows that half of the patients disregard this rule - some reuse each needle up to five times. Studies show that patients do not like carrying extra needles when they are away from home, are reluctant to carry containers to dispose used needles, and decide that it is not worthwhile worth buying a new needle for each injection. Others describe that injections from reused needles are not noticeably more painful as long as they do not reuse them excessively. Finally, some patients believe that disposing of a needle after use is ecologically wasteful because metal and plastic must be incinerated. A randomized clinical trial will be carried out to compare the reuse or not of needles in patients with diabetes who use insulin. Primary outcomes as skin complications, local pain, glycemic control will be evaluated at baseline and after 4, 8 and 12 weeks and secondary outcomes will also be evaluated as quality of life, insulin application technique, frequency of capillary blood glucose tests, adherence to treatment, quality of needles, microbiological contamination and cost-utility analysis of after needle reuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was blinded to the professionals involved in the analyses of skin complications and the needle characterization test.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM
- •Over 18 years of age
- •Reuses each syringe at least three times for insulin application.
排除标准
- •Use of insulin pens
- •Pregnant women
- •Patients undergoing chemotherapy
- •Use of anticoagulants
- •Clotting disorders, lesions or skin changes
结局指标
主要结局
Change in glycemic control
时间窗: Baseline and Month 3
For assessment of glycemic control, HbA1c will be requested if the patient has not performed the test in the last month at the initial meeting and at the end of the study, after 12 weeks, for all patients.
Change in Skin complications
时间窗: Baseline, Month1, Month 2 and Month 3
Dermatological conditions will be evaluated for the formation of hematomas, ecchymoses, appearance of lipodystrophy (lipohypertrophy and lipoatrophy), signs of inflammation and pain in the applications. In the follow-up meetings, the skin complications presented by the patient at the insulin injection sites will be recorded through photography by the professional. To aid in the evaluation of skin complications, a partnership will be established carried out with the TeleHealth Program, where distance and standard pixel size will be used for photos of patients' skin complications through a professional digital camera.
Change in Pain assessment
时间窗: Baseline, Month1, Month 2 and Month 3
The evaluation of pain in the application of insulin will be evaluated through a one-dimensional numerical scale of pain intensity, according to the clinical record in the follow-up meetings which consists of numbers from 0 to 10 (0 = " no pain" to 10= "worst pain imaginable").
次要结局
- Evaluate the quality of needles after reuse of the insulin administration needle compared to non-reuse.(Month 2)
- Evaluate the microbiological contamination after reuse of the insulin administration needle compared to non-reuse.(Month 2)
- Frequency of reuse of lancets of included patients(Baseline)
- Adherence to diabetes treatment(Baseline, Month1, Month 2 and Month 3)
- Quality of life assessment(Baseline, Month1, Month 2 and Month 3)
- Insulin Injection technique(Baseline and Month 3)
- Analyze cost-utility(Baseline, Month1, Month 2 and Month 3)
- Frequency of capillary blood glucose tests(Baseline)