ACCU-CHEK Connect Personal Diabetes Management Study (PDM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 11
- 主要终点
- Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24
研究概览
简要总结
This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 or type 2 diabetes for greater than or equal to (>=) 6 months
- •Currently using insulin as a component of the diabetes therapy
- •Allow and be able to provide self-monitoring of blood glucose (SMBG) data at least 1 month prior to study start
- •SMBG frequency as confirmed by site SMBG data download of participants meter(s): Basal insulin treated participants - SMBG >=5 times per week and Multiple dose insulin participants - SMBG >=2 times per day
- •Glycosylated hemoglobin (HbA1c) of >=7.5 percentage (per local laboratory obtained less than or equal to [<= 3] months of Baseline)
- •Able to read and write in English language
- •Currently using a Smartphone and have experience with downloading at minimum one application
- •Smartphone compatibility; must be able to download the ACCU-CHEK Connect system application accordingly
- •Naive to the ACCU-CHEK Connect system
- •Willing to comply with study procedures
排除标准
- •Treatment with insulin pump therapy
- •Any use of continuous glucose monitoring (CGM) to manage their diabetes during the course of the study
- •Visually impaired
- •Women who are pregnant, lactating or planning to become pregnant during the study period
- •Diagnosed with any clinically significant condition (for example anemia, major organ system disease, infections, psychosis or cognitive impairment)
- •Participant requires chronic steroid in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
- •Participant is the investigator or any sub-investigator, general practitioner, practice staff, pharmacist, research assistant or other staff or relative of those directly involved in the conduct of the study and design of the protocol
研究组 & 干预措施
ACCU-CHEK
All participants will utilize ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
干预措施: ACCU-CHEK (Device)
结局指标
主要结局
Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24
时间窗: Week 24
The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.
次要结局
- Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score(Baseline, Week 24)
- Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range(Baseline, Week 24)
- Change From Baseline to Week 24 in Mean Blood Glucose Level(Baseline, Week 24)
- Change From Baseline to Week 24 in Glycemic Variability(Baseline, Week 24)
- Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24(Week 24)
- Percent of Follow-Up Visits With Sufficient SMBG Data(Up to Week 24)
- Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Percentage of Blood Glucose Tagged Data(Weeks 12 and 24)
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Incidence of Hypoglycemia(Baseline, Weeks 12 and 24)
- Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24(Baseline, Weeks 12 and 24)