Efficiency Assessment of the Structured Education Program for Type 1 Diabetes Patients on Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- HbA1c
研究概览
简要总结
The purpose of this study is to assess the effectiveness of structured group education on glycemic control and Quality of Life (QoL) among users of continuous subcutaneous insulin infusions (CSII).
详细描述
The study will include 80 patients with type 1 diabetes that will be transferred from multiple daily injection (MDI) regimen to continuous subcutaneous insulin infusion (CSII). All patients will be divided into 2 groups: 1) structured education group (n=40) and 2) control group (n=40).
Patients from structured education group will be transferred from MDI to CSII using special structured education program for type 1 diabetes patients on insulin pump therapy. Before the transferring to CSII the patients from this group will be randomized in two subgroups, depending on type of blood glucose control: patients which will use CSII and self-monitoring of blood glucose (SMBG) (n=20) or patients which will use sensor-augmented pump (SAP) (n=20).
Follow-up duration in structured education group will be 4 months; follow-up visits included treatment adjustment, glucose data review and and collection of data on adverse events every 4 weeks. Between visits, communication with clinicians will be initiated at the discretion of the patient.
The control group will include patients with type 1 diabetes using CSII during 4-6 months before. The patients from this group will be divided in two subgroups, depending on type of self blood glucose control: patients using CSII (n=20) and SMBG or patients using SAP (n=20). In this group patients should be transferred to CSII by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated in intensive diabetes management, including carbohydrate counting, the administration of correction doses of insulin and technical aspects of CSII and self glucose control by continuous glucose monitoring in real-time ("CGM-RT").
All patients will provide written informed consent.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus;
- •Disease duration > 1 year;
- •Patients informed consent, approving participation and completion of questionnaires.
排除标准
- •Severe late diabetic complications (diabetic foot syndrome, painful neuropathy, autonomic neuropathy, significant loss of vision, glomerular filtration rate < 30 ml/min/1.73 m2);
- •Pregnancy;
- •Severe concomitant diseases;
- •Known psychic disorders and/or treatment with psychotropic medicines.
研究组 & 干预措施
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: Education by structured programme (Behavioral)
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: CSII (Device)
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: CGM-RT (Device)
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: Screening for Complications (Procedure)
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: Glycaemic control assessment (Procedure)
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: QoL assessment (Procedure)
SAP + Group Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) in group using specialised structured education program. CGM will be used for self monitoring of blood glucose permanently within 4 month.
干预措施: Knowledge assessment (Procedure)
SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: CSII (Device)
SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: CGM-RT (Device)
SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: Screening for Complications (Procedure)
SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: Glycaemic control assessment (Procedure)
SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: QoL assessment (Procedure)
SAP + Standard Education
Patients will be transferred from MDI to sensor-augmented pump (SAP) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: Knowledge assessment (Procedure)
CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
干预措施: Education by structured programme (Behavioral)
CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
干预措施: CSII (Device)
CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
干预措施: Screening for Complications (Procedure)
CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
干预措施: Glycaemic control assessment (Procedure)
CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
干预措施: QoL assessment (Procedure)
CSII + Group Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program.
干预措施: Knowledge assessment (Procedure)
CSII + Standard Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: CSII (Device)
CSII + Standard Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: Screening for Complications (Procedure)
CSII + Standard Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: Glycaemic control assessment (Procedure)
CSII + Standard Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: QoL assessment (Procedure)
CSII + Standard Education
Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier.
干预措施: Knowledge assessment (Procedure)
结局指标
主要结局
HbA1c
时间窗: 4 month after CSII initiation
HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.
次要结局
- Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)(within 4 month of the study)
- Glycaemic Variability(within 4 month of the study)
- Quality of Life (ADDQoL Questionnaire)(4 month after CSII initiation)
- Quality of Life (SF36 Questionnaire)(4 months after CSII initiation)
- Severe Hypoglycaemia Frequency(within 4 month of the study)
- Nonsevere Hypoglycaemia Frequency(within 4 month of the study)
研究者
Ibragimova Lyudmila
MD, PhD
Endocrinology Research Centre, Moscow