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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

Prospective Comparison of Connected Solution (Health2Sync) and Usual Care in Adult Participants With Type 2 Diabetes Mellitus Using Basal Insulin in Taiwan

NCT05684341•Sanofi

View on ClinicalTrials.gov

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

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (14)

Changhua Christian Hospital - Investigational Site Number: 1580016

Changhua, Taiwan

Kaohsiung Veterans General Hospital - Investigational site number 1580010

Kaohsiung 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

Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005

New Taipei City, Taiwan

Chung-Shan University Hospital - Investigational Site Number: 1580003

Taichung, Taiwan

Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011

Taichung, Taiwan

National Cheng Kung University Hospital - Investigational Site Number: 1580008

Tainan, Taiwan

Chi-Mai Medical Center - Investigational Site Number: 1580002

Tainan, Taiwan

National Taiwan University Hospital - Investigational site number 1580001

Taipei, Taiwan

Key Dates

Start Date

February 17, 2023

Primary Completion Date

June 18, 2024

Completion Date

June 18, 2024

Last Updated

July 17, 2024

Enrollment

200

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Connected Solution with H2S app which connects with blood glucose meter (BGM)

COMBINATION_PRODUCT

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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