NCT05684341已完成不适用
Prospective Comparison of Connected Solution (Health2Sync) and Usual Care in Adult Participants With Type 2 Diabetes Mellitus Using Basal Insulin in Taiwan
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 200
- 试验地点
- 28
- 主要终点
- Change from baseline in HbA1c at Week 24
研究概览
简要总结
The Connected Solution investigated in this study is the combination of the titration module "Insultrate" and a cell phone application (app) named Health2Sync (H2S) that synchronizes participants' self-monitoring blood glucose data and electronic health records to a platform overseen by their treating physicians. This study investigates if this Connected Solution helps to improve glycemic control more effectively than physician-recommended routine management (i.e., usual care) in participants with Type 2 Diabetes Mellitus (T2DM).
详细描述
Study duration per participant will be up to 9 months, including a screening period of up to 3 months and a study intervention period of 24 weeks (± 14 days).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥ 20 years of age at the time of signing the informed consent
- •Participants were diagnosed with T2DM prior to the screening visit
- •Participants who are insulin naïve, or already treated with basal insulin but uncontrolled with the same insulin regimen for at least 3 months (90 days) prior to Day 1
- •Participants with HbA1c between 7.5% and 11% (inclusive) at the screening visit and Day 1
- •Participants with fasting self-measured blood glucose (fSMBG) or fasting plasma glucose (FPG) >130 mg/dL at the screening visit and Day 1
- •Capable of giving signed informed consent
- •Willing and able to use the H2S app and glucometer
排除标准
- •Participants with diabetes other than T2DM
- •H2S app/ BGM is not appropriate for the participant or use of device is otherwise contraindicated (in the opinion of the investigators)
- •Participants with hypoglycemia unawareness or with severe hypoglycemia within the past 90 days prior to the screening visit and until Day 1
- •Hospitalization (for any reason) in the past 30 days prior to the screening visit and until Day 1
- •Participants with severe conditions/concomitant diseases precluding their safety or ability to participate in this study, as judged by the investigators - Participants are not on stable dose of glucose lowering therapy including OADs, glucagon-like peptide-1 (GLP-1) receptor agonists, or basal insulin therapy within the past 12 weeks prior to the screening visit and until Day 1 per investigator's discretion
- •Participants using mealtime insulin for more than 10 days in the last 90 days before the screening visit and until Day 1
- •Participants who used H2S app within 1 month prior to the screening visit and until Day 1 randomization
- •Participants who have taken other investigational drugs within 90 days or 5 half-lives prior to screening or randomization, whichever is longer
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Device Intervention arm
Experimental
Connected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants
干预措施: Connected Solution with H2S app which connects with blood glucose meter (BGM) (Combination Product)
No Device Control arm
No Intervention
Physician-recommended routine management (usual care) to support glycemic control in T2DM participants
结局指标
主要结局
Change from baseline in HbA1c at Week 24
时间窗: Baseline to Week 24
次要结局
- Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24(Baseline to Week 24)
- Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24(Week 24)
- Number of participants experiencing hypoglycemia during the 24-week study period(Baseline to Week 24)
- Percentage of participants with at least one emergency room (ER) visit or hospitalization record due to hypoglycemia event during the 24-week study period(Baseline to Week 24)
- Insulin discontinuation rate at Week 12 and 24(Week 12 and 24)
- Number of participants experiencing hypoglycemia(Baseline to Week 24)
- Number of hypoglycemic events per patient-year during the 24-week study period(Baseline to Week 24)
- Time to first reach the fSMBG target range(Baseline to Week 24)
- Insulin compliance at Week 12 and 24(Week 12 and 24)
- Change from baseline in total daily insulin dose at Week 12 and 24(Baseline to Week 12 and 24)
- Change from baseline in body weight at Week 12 and 24(Baseline to Week 12 and 24)
- Change from baseline in the score of Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at Week 12 and 24(Baseline to Week 12 and 24)
- Change from baseline in the score of the European Quality of Life 5-Dimensions 3-Level Version (EQ-5D-3L) at Week 12 and 24(Baseline to Week 12 and 24)
- Number of participants with adverse events during the 24-week study period(Baseline to Week 24)
- Emergency room (ER) visits or hospitalizations due to hypoglycemia event(Baseline to Week 24)
研究者
研究点 (28)
Loading locations...
相似试验
终止
4 期
Amniotic Membrane Allograft Application in the Management of Venous Leg UlcerationsVaricose UlcerVenous InsufficiencyNCT02929056Prisma Health-Upstate2
已完成
不适用
Evaluation of a Digital Diabetes Self-Management Education and Support ProgramType 2 DiabetesNCT05368454Omada Health, Inc.100
Unknown
不适用
Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEPBPHProstate ObstructionNCT04342533I.M. Sechenov First Moscow State Medical University140
Unknown
不适用
Effectiveness of Recovery Protocols Combination in Soccer PlayersSoccerPhysical StressFatigueNCT04841733University of Vic - Central University of Catalonia20
已完成
1 期
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting ConditionsHealthyNCT01161927Dr. Reddy's Laboratories Limited26