Clinical trial NCT05684341: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from baseline in HbA1c at Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24
timeFrame: Baseline to Week 24
measure: Time to first reach the fSMBG target range
timeFrame: Baseline to Week 24
measure: Insulin compliance at Week 12 and 24
timeFrame: Baseline to Week 12 and 24
measure: Insulin discontinuation rate at Week 12 and 24
timeFrame: Week 12 and 24
measure: Change from baseline in total daily insulin dose at Week 12 and 24
timeFrame: Baseline to Week 12 and 24
measure: Change from baseline in body weight at Week 12 and 24
timeFrame: Baseline to Week 12 and 24
measure: Change from baseline in the score of Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at Week 12 and 24
timeFrame: Baseline to Week 12 and 24
measure: Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Baseline to Week 12 and 24
measure: Number of participants experiencing hypoglycemia
timeFrame: Baseline to Week 24
measure: Number of hypoglycemic events per patient-year during the 24-week study period
timeFrame: Baseline to Week 24
measure: Emergency room (ER) visits or hospitalizations due to hypoglycemia event
timeFrame: Baseline to Week 24
measure: Insulin compliance at Week 12 and 24
timeFrame: Week 12 and 24
measure: Number of participants experiencing hypoglycemia during the 24-week study period
timeFrame: Baseline to Week 24
measure: Percentage of participants with at least one emergency room (ER) visit or hospitalization record due to hypoglycemia event during the 24-week study period
timeFrame: Baseline to Week 24
measure: Number of participants with adverse events during the 24-week study period
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital - Investigational Site Number: 1580016
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital - Investigational site number 1580010
city: New Taipei city
country: Taiwan
facility: Far-Eastern Memorial Hospital - Investigational Site Number: 1580004
city: New Taipei city
country: Taiwan
facility: Shuang Ho Hospital - Investigational Site Number: 1580012
city: New Taipei city
country: Taiwan
facility: Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005
city: Taichung
country: Taiwan
facility: Chung-Shan University Hospital - Investigational Site Number: 1580003
city: Taichung
country: Taiwan
facility: Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital - Investigational Site Number: 1580008
city: Tainan
country: Taiwan
facility: Chi-Mai Medical Center - Investigational Site Number: 1580002
city: Taipei city
country: Taiwan
facility: Cathay General Hospital - Investigational Site Number: 1580006
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital - Investigational Site Number: 1580015
city: Taipei city
country: Taiwan
facility: Tri-Service General Hospital - Investigational Site Number: 1580014
city: Taipei city
country: Taiwan
facility: Wan Fang Hospital - Investigational Site Number: 1580013
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital - Investigational site number 1580001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: