Wearable continuous glucose and ketone monitor for adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Up to 14 adults with type 1 diabetes who use continuous subcutaneous insulin infusion will be enrolled and will make three clinic visits including a screening visit. At each sampling visit venous blood will be drawn for YSI and Randox venous plasma reference measurements and interstitial glucose and ketone readings will be obtained from the investigational sensor immediately after each blood draw. The study compares sensor readings to reference lab values to determine analytical accuracy and documents any device- or site-related safety issues. Key exclusions are recent severe hypoglycemia or DKA, significant skin disorders at the sensor site, anemia or abnormal hematocrit, recent blood donation, pregnancy/lactation, anticoagulant use, or planned MR.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)
* Venous blood sampling access can be established in the forearm
* Capable of independently reading instructions and complying with the clinical trial requirements
* Willing to sign the Informed Consent Form (ICF)

Exclusion Criteria:

* Severe hypoglycemia within the past 6 months
* A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
* Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
* Severe skin conditions at the sensor wear site
* Extensive systemic skin disorders
* Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications
* Anemia or abnormal hematocrit
* Blood donation within the past 6 months
* Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
* Current or recent (≤1 month) participation in other clinical trials
* Planned MRI/CT scans during sensor wear
* Allergy to medical adhesives or alcohol
* Conditions impairing comprehension of informed consent or study procedures
* Other exclusionary conditions per investigator's discretion

Where it's running

• The First Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Henan University of Science and Technology
  Luoyang, Henan, China Recruiting

Study contacts

• Principal investigator: Hongwei Jiang — Henan University of Science and Technology
• Study coordinator: Peng Liu
• Email: peng.liu87@outlook.com
• Phone: 0379-64811993

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuous Glucose Monitor Accuracy and Safety in Adults with Type 1 Diabetes

  This study tests a new real-time CGM system in adults with type 1 diabetes to see if its readings match venous blood glucose measurements.

  Recruiting SiBionics, Co, Ltd · Zibo, Shandong · NCT07745244

• Thrive With Type 1 Diabetes: A Behavioral Program to Improve Glucose and Sleep

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• Cardiometabolic effects of non-nutritive sweeteners in Type 1 diabetes

  This study tests whether non-nutritive sweeteners in a 12-ounce cherry Gatorade drink affect blood sugar control and cardiovascular markers in teens and young adults with Type 1 diabetes.

  Recruiting Medical College of Wisconsin · Milwaukee, Wisconsin · NCT07434544

• Tirzepatide for obesity in people with type 1 diabetes

  This trial will test whether tirzepatide helps adults with type 1 diabetes and obesity lose weight and is safe for them.

  Recruiting Phase 4 Dasman Diabetes Institute · Kuwait City, Sharq · NCT07096908

• New real-time continuous glucose monitor accuracy and safety in adults with type 1 diabetes

  This project will test a new real-time continuous glucose monitor to see if its sensor readings match lab venous plasma (YSI) measurements in adults with type 1 diabetes.

  Recruiting Henan University of Science and Technology · Luoyang, Henan · NCT07092761

• Dapagliflozin, Pioglitazone, and Ketone Production in Type 1 Diabetes

  This study tests whether adding pioglitazone to dapagliflozin in adults with type 1 diabetes can lessen liver glucose production, fat breakdown, and ketone production while on insulin.

  Recruiting Phase 3 The University of Texas Health Science Center at San Antonio · San Antonio, Texas · NCT07056699

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.