Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic controlCONTROL
试验速览
- 阶段
- 4 期
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin
研究概览
简要总结
This is a prospective, intervention, randomized, phase IV study. Patients will be included with 60 years or older, both sexes, with HbA1c >8.5% using oral antidiabetics agents and insulin and then we will be randomized by use syringe or pens device to use insulin NPH and regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients will see monthly.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty years or older
- •Diabetes type 2 with Glycated Hemoglobin higher than 8.5%
- •Using or necessity to use insulin
- •Using syringe to insulin
- •Using at least one oral antidiabetic
- •Accept to participate
排除标准
- •Glomerular Filtration Rate lower than 30
- •Considering unfit for self administration of insulin
研究组 & 干预措施
Pens Device
All patients will receive pens device, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
干预措施: Pens Device (Device)
Pens Device
All patients will receive pens device, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
干预措施: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) (Other)
Syringe
All patients will receive syringe to insulin, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
干预措施: Syringe (Device)
Syringe
All patients will receive syringe to insulin, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
干预措施: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) (Other)
结局指标
主要结局
Glycated Hemoglobin
时间窗: reduction compared to baseline values at six months
reduction compared to baseline values
次要结局
- Blood Pressure(reduction compared to baseline values at six months)
- adherence(reduction compared to baseline values at six months)
- Number of pills, antidiabetics drugs and antihypertensives drugs(reduction compared to baseline values at six months)
- Number of hypoglycemias(reduction compared to baseline values at six months)
- Presence of severe hypoglycemias(reduction of the number of patients with this outcome compared to baseline values at six months)
- Presence of nocturnal hypoglycemias(reduction of the number of patients with this outcome compared to baseline values at six months)
- Presence of asyntomatic hypoglycemias(reduction of the number of patients with this outcome compared to baseline values at six months)
研究者
Ticiana da Costa Rodrigues
Professor of Medicine
Hospital de Clinicas de Porto Alegre