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

Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System

This trial will test if a new wearable device can continuously and accurately measure glucose and ketone levels in adults with type 1 diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan University of Science and Technology (Academic / other)
• Locations: 2 sites (Shijiazhuang, Hebei and 1 other locations)
• Trial ID: NCT07139808 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with type 1 diabetes on insulin pump therapy who can have forearm venous sampling, read instructions, and attend three in-person visits are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have recent DKA or severe hypoglycemia, significant skin disorders at the sensor site, anemia or abnormal hematocrit, use anticoagulants, recently donated blood, or cannot attend the on-site visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If accurate and safe, the device could give people with type 1 diabetes real-time glucose and ketone information to help detect ketosis earlier and improve day-to-day management.

How similar studies have performed: Continuous glucose monitoring is well established, but real-time combined continuous glucose-and-ketone sensors are novel with limited published evidence to date.

Eligibility criteria

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 this trial is running

Shijiazhuang, Hebei and 1 other locations

• 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

Conditions Type1diabetes