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

Study on Improving Glycemic Control in Type 2 Diabetes with a Connected Solution

Not Recruiting
20 years or above
All
Phase N/A
200 participants needed

Study Overview

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).

Study Details

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 2 Diabetes Mellitus
  • Age: 20 years or above
  • Gender: All

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.

Updated on 17 Jul 2024. Study ID: NCT05684341

This study investigates the effectiveness of a Connected Solution for people with Type 2 Diabetes Mellitus (T2DM). The purpose of the study is to see if using a combination of a titration module called "Insultrate" and a phone app named Health2Sync (H2S) can improve blood sugar control better than the usual care recommended by doctors. Type 2 Diabetes Mellitus is a condition where the body does not use insulin properly, leading to high blood sugar levels.

Participants in the study will use the Health2Sync app to monitor their blood sugar levels. This app syncs their data with their electronic health records, allowing their doctors to oversee their condition. The study will compare this method with regular management practices to see which is more effective in controlling blood sugar levels.

  • Who can participate: Adults aged 20 and older with Type 2 Diabetes Mellitus can participate. They must have uncontrolled blood sugar levels despite using basal insulin and have specific blood sugar readings. Participants must be willing to use the Health2Sync app and glucometer.
  • Study details: Participants will use the Health2Sync app to track their blood sugar levels, which will be shared with their doctors. They will follow the study procedures to see if this method improves their diabetes management compared to usual care.
  • Study timelines: The study will last up to 9 months.