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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05684341
• Other study ID #: PIR17344
• Secondary ID: U1111-1266-5860
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Combination Product:
• Connected Solution with H2S app which connects with blood glucose meter (BGM)
Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital - Investigational Site Number: 1580016	Changhua
Taiwan	Kaohsiung Veterans General Hospital - Investigational site number 1580010	Kaohsiung
Taiwan	Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005	New Taipei city
Taiwan	Far-Eastern Memorial Hospital - Investigational Site Number: 1580004	New Taipei city
Taiwan	Shuang Ho Hospital - Investigational Site Number: 1580012	New Taipei city
Taiwan	Chung-Shan University Hospital - Investigational Site Number: 1580003	Taichung
Taiwan	Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011	Taichung
Taiwan	Chi-Mai Medical Center - Investigational Site Number: 1580002	Tainan
Taiwan	National Cheng Kung University Hospital - Investigational Site Number: 1580008	Tainan
Taiwan	National Taiwan University Hospital - Investigational site number 1580001	Taipei
Taiwan	Cathay General Hospital - Investigational Site Number: 1580006	Taipei city
Taiwan	Taipei Veterans General Hospital - Investigational Site Number: 1580015	Taipei city
Taiwan	Tri-Service General Hospital - Investigational Site Number: 1580014	Taipei city
Taiwan	Wan Fang Hospital - Investigational Site Number: 1580013	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at Week 24		Baseline to Week 24
Secondary	Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24		Baseline to Week 24
Secondary	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	Baseline to Week 24
Secondary	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%	Baseline to Week 12 and 24
Secondary	Insulin discontinuation rate at Week 12 and 24	Percentage of participants who are discontinued from the insulin injection at Week 12 and 24	Week 12 and 24
Secondary	Change from baseline in total daily insulin dose at Week 12 and 24		Baseline to Week 12 and 24
Secondary	Change from baseline in body weight at Week 12 and 24		Baseline to Week 12 and 24
Secondary	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
Secondary	Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24		Week 24
Secondary	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
Secondary	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	Baseline to Week 24
Secondary	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	Baseline to Week 24
Secondary	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	Baseline to Week 24
Secondary	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%	Week 12 and 24
Secondary	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	Baseline to Week 24
Secondary	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
Secondary	Number of participants with adverse events during the 24-week study period		Baseline to Week 24