Back to resultsA Randomized Controlled Trial to Compare the Glycemic Control, With or Without the Connected Solution, of Adult Type 2 Diabetic Participants on Basal Insulin in Taiwan (TW CES RCT)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Connected Solution with H2S app which connects with blood glucose meter (BGM)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Changhua Christian Hospital - Investigational Site Number: 1580016Recruiting
- Kaohsiung Veterans General Hospital - Investigational site number 1580010Recruiting
- Far-Eastern Memorial Hospital - Investigational Site Number: 1580004Recruiting
- Shuang Ho Hospital - Investigational Site Number: 1580012Recruiting
- Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005Recruiting
- Chung-Shan University Hospital - Investigational Site Number: 1580003Recruiting
- Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011Recruiting
- National Cheng Kung University Hospital - Investigational Site Number: 1580008Recruiting
- Chi-Mai Medical Center - Investigational Site Number: 1580002Recruiting
- Cathay General Hospital - Investigational Site Number: 1580006Recruiting
- Taipei Veterans General Hospital - Investigational Site Number: 1580015Recruiting
- Tri-Service General Hospital - Investigational Site Number: 1580014Recruiting
- Wan Fang Hospital - Investigational Site Number: 1580013Recruiting
- National Taiwan University Hospital - Investigational site number 1580001Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Device Intervention arm
No Device Control arm
Arm Description
Connected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants
Physician-recommended routine management (usual care) to support glycemic control in T2DM participants
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c at Week 24
Secondary Outcome Measures
Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24
Time to first reach the fSMBG target range
The time to first fSMBG reaching target range of 80 to 130 mg/dL (inclusive) will be defined as the time interval from Day 1 to the first date of reaching the target fSMBG
Insulin compliance at Week 12 and 24
Compliance (%) = (the total days of participants with insulin injecting as prescribed regimen / the total days of prescribed regimen)*100%
Insulin discontinuation rate at Week 12 and 24
Percentage of participants who are discontinued from the insulin injection at Week 12 and 24
Change from baseline in total daily insulin dose at Week 12 and 24
Change from baseline in body weight at Week 12 and 24
Change from baseline in the score of Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at Week 12 and 24
Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 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
Number of participants experiencing hypoglycemia
The number of participants experiencing hypoglycemia during the 24-week study period will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available
Number of hypoglycemic events per patient-year during the 24-week study period
The hypoglycemic events will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available
Emergency room (ER) visits or hospitalizations due to hypoglycemia event
Percentage of participants with at least one ER visit or hospitalization record due to hypoglycemia event per the judgment of investigators
Insulin compliance at Week 12 and 24
Compliance (%) = (the total days of participants with insulin injecting as prescribed regimen / the total days of prescribed regimen)*100%
Number of participants experiencing hypoglycemia during the 24-week study period
The number of participants will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available
Percentage of participants with at least one emergency room (ER) visit or hospitalization record due to hypoglycemia event during the 24-week study period
Number of participants with adverse events during the 24-week study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05684341
Brief Title
A Randomized Controlled Trial to Compare the Glycemic Control, With or Without the Connected Solution, of Adult Type 2 Diabetic Participants on Basal Insulin in Taiwan
Acronym
TW CES RCT
Official Title
Prospective Comparison of Connected Solution (Health2Sync) and Usual Care in Adult Participants With Type 2 Diabetes Mellitus Using Basal Insulin in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
March 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device Intervention arm
Arm Type
Experimental
Arm Description
Connected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants
Arm Title
No Device Control arm
Arm Type
No Intervention
Arm Description
Physician-recommended routine management (usual care) to support glycemic control in T2DM participants
Intervention Type
Combination Product
Intervention Name(s)
Connected Solution with H2S app which connects with blood glucose meter (BGM)
Intervention Description
Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at Week 24
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24
Time Frame
Baseline to Week 24
Title
Time to first reach the fSMBG target range
Description
The time to first fSMBG reaching target range of 80 to 130 mg/dL (inclusive) will be defined as the time interval from Day 1 to the first date of reaching the target fSMBG
Time Frame
Baseline to Week 24
Title
Insulin compliance at Week 12 and 24
Description
Compliance (%) = (the total days of participants with insulin injecting as prescribed regimen / the total days of prescribed regimen)*100%
Time Frame
Baseline to Week 12 and 24
Title
Insulin discontinuation rate at Week 12 and 24
Description
Percentage of participants who are discontinued from the insulin injection at Week 12 and 24
Time Frame
Week 12 and 24
Title
Change from baseline in total daily insulin dose at Week 12 and 24
Time Frame
Baseline to Week 12 and 24
Title
Change from baseline in body weight at Week 12 and 24
Time Frame
Baseline to Week 12 and 24
Title
Change from baseline in the score of Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at Week 12 and 24
Time Frame
Baseline to Week 12 and 24
Title
Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24
Time Frame
Week 24
Title
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
Time Frame
Baseline to Week 12 and 24
Title
Number of participants experiencing hypoglycemia
Description
The number of participants experiencing hypoglycemia during the 24-week study period will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available
Time Frame
Baseline to Week 24
Title
Number of hypoglycemic events per patient-year during the 24-week study period
Description
The hypoglycemic events will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available
Time Frame
Baseline to Week 24
Title
Emergency room (ER) visits or hospitalizations due to hypoglycemia event
Description
Percentage of participants with at least one ER visit or hospitalization record due to hypoglycemia event per the judgment of investigators
Time Frame
Baseline to Week 24
Title
Insulin compliance at Week 12 and 24
Description
Compliance (%) = (the total days of participants with insulin injecting as prescribed regimen / the total days of prescribed regimen)*100%
Time Frame
Week 12 and 24
Title
Number of participants experiencing hypoglycemia during the 24-week study period
Description
The number of participants will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available
Time Frame
Baseline to Week 24
Title
Percentage of participants with at least one emergency room (ER) visit or hospitalization record due to hypoglycemia event during the 24-week study period
Time Frame
Baseline to Week 24
Title
Number of participants with adverse events during the 24-week study period
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US and Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Christian Hospital - Investigational Site Number: 1580016
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Veterans General Hospital - Investigational site number 1580010
City
Kaohsiung
ZIP/Postal Code
813414
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Far-Eastern Memorial Hospital - Investigational Site Number: 1580004
City
New Taipei city
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Shuang Ho Hospital - Investigational Site Number: 1580012
City
New Taipei city
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005
City
New Taipei city
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chung-Shan University Hospital - Investigational Site Number: 1580003
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011
City
Taichung
ZIP/Postal Code
435403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital - Investigational Site Number: 1580008
City
Tainan
ZIP/Postal Code
704302
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi-Mai Medical Center - Investigational Site Number: 1580002
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Cathay General Hospital - Investigational Site Number: 1580006
City
Taipei city
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital - Investigational Site Number: 1580015
City
Taipei city
ZIP/Postal Code
112201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital - Investigational Site Number: 1580014
City
Taipei city
ZIP/Postal Code
114202
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Wan Fang Hospital - Investigational Site Number: 1580013
City
Taipei city
ZIP/Postal Code
116079
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital - Investigational site number 1580001
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
A Randomized Controlled Trial to Compare the Glycemic Control, With or Without the Connected Solution, of Adult Type 2 Diabetic Participants on Basal Insulin in Taiwan
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