AI-Assisted Remote Insulin Pump Optimization in T1DM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About this trial
This study evaluates an AI-assisted remote parameter optimization tool for individuals with type 1 diabetes （T1D） using insulin pump and continuous glucose monitoring (CGM). The Artificial Intelligence (AI) algorithm analyzes regularly CGM and insulin data to generate personalized recommendations for adjusting pump settings. All algorithm-generated recommendations are reviewed and approved by physicians before being transmitted to the participant's mobile application for implementation.
Eligibility criteria
Qualifiers
Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis;
At least one of the following: age at disease onset < 15 years; presentation with ketosis or diabetic ketoacidosis (DKA) at onset; no overweight or obesity at onset; highest random C-peptide < 200 pmol/L;
At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody.
Age 14 to 65 years, inclusive, male or female.
Disqualifiers
History of severe hypoglycemia within the 6 months prior to screening, defined as an event requiring medical assistance (i.e., physician office visit, emergency room visit, or hospitalization), coma, seizure, or hypoglycemia with loss of consciousness.
Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment.
Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening.
Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema.
Trial design
Treatments tested in this trial
- AI-Assisted Insulin Pump Settings Optimization System
- Conventional Insulin Pump Therapy
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov