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

NCT05684341 | Completed

• 2 other identifiers: PIR17344U1111-1266-5860
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 14

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c at Week 24

  Baseline to Week 24

Secondary Outcomes (16)

• Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24

  Baseline to Week 24

• Time to first reach the fSMBG target range

  Baseline to Week 24

• Insulin compliance at Week 12 and 24

  Baseline to Week 12 and 24

• Insulin discontinuation rate 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

Study Arms (2)

Device Intervention arm

EXPERIMENTAL

Connected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants

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

No Device Control arm

NO INTERVENTION

Physician-recommended routine management (usual care) to support glycemic control in T2DM participants

Interventions

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

Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals

Device Intervention arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (14)

Changhua Christian Hospital - Investigational Site Number: 1580016

Changhua, 500, Taiwan

Location

Kaohsiung Veterans General Hospital - Investigational site number 1580010

Kaohsiung City, 813414, Taiwan

Location

Far-Eastern Memorial Hospital - Investigational Site Number: 1580004

New Taipei City, 220, Taiwan

Location

Shuang Ho Hospital - Investigational Site Number: 1580012

New Taipei City, 235, Taiwan

Location

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

New Taipei City, 33305, Taiwan

Location

Chung-Shan University Hospital - Investigational Site Number: 1580003

Taichung, 40201, Taiwan

Location

Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011

Taichung, 435403, Taiwan

Location

National Cheng Kung University Hospital - Investigational Site Number: 1580008

Tainan, 704302, Taiwan

Location

Chi-Mai Medical Center - Investigational Site Number: 1580002

Tainan, 710, Taiwan

Location

National Taiwan University Hospital - Investigational site number 1580001

Taipei, 100, Taiwan

Location

Cathay General Hospital - Investigational Site Number: 1580006

Taipei, 106, Taiwan

Location

Taipei Veterans General Hospital - Investigational Site Number: 1580015

Taipei, 112201, Taiwan

Location

Tri-Service General Hospital - Investigational Site Number: 1580014

Taipei, 114202, Taiwan

Location

Wan Fang Hospital - Investigational Site Number: 1580013

Taipei, 116079, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: February 17, 2023
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

TW (14)