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.
This study consists of two independent, parallel cohorts. Participants are assigned to only one of the two cohorts and do not crossover between cohorts. Cohort 1 (Inpatient Phase): A separate group of hospitalized adults with T1D will undergo AI-assisted insulin pump parameter optimization over 5-7 days under close clinical supervision. This cohort is designed to evaluate the short-term safety, feasibility, and glycemic responses to the AI algorithm in a controlled inpatient setting. Cohort 2 (Home-based Phase): A separate group of outpatients with T1D will be randomized in a 1:1 ratio to a two-period crossover design over 11 weeks. This cohort evaluates the efficacy and safety of AI-assisted remote parameter optimization compared to conventional therapy in the home environment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
A cloud-based software system that analyzes continuous glucose monitoring and insulin pump data to generate recommendations for optimizing insulin pump settings. All recommendations are reviewed and approved by a physician prior to implementation.
Sensor-augmented insulin pump therapy using continuous glucose monitoring with dose adjustments made by the participant and/or physician per standard clinical practice, without AI-assisted algorithmic recommendations.
Department of Endocrinology
Nanjing, Jiangsu, China
RECRUITINGTime-in-Range (TIR)
Percentage of glucose readings within range of 3.9 to 10 mmol/l
Time frame: the last 2 weeks of each 4-week intervention period
Percentage of Time with Glucose Below 3.9 mmol/L
Percentage of CGM readings below 3.9 mmol/L during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
Percentage of Time with Glucose Above 10.0 mmol/L
Percentage of CGM readings above 10.0 mmol/L during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
Mean Sensor Glucose
Mean CGM glucose level (mmol/L) during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
Glycemic Variability
coefficient of variation (%CV) of CGM glucose levels during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
Total Daily Insulin Dose
Mean total daily insulin dose (units/day) during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
Incidence of Diabetic Ketoacidosis (DKA)
Number of DKA events occurring during the study.
Time frame: through study completion, an average of 12 weeks
Incidence of Severe Hypoglycemic Events
Number of severe hypoglycemic events (requiring assistance of another person) during the study.
Time frame: through study completion, an average of 12 weeks
Incidence of Adverse Events and Serious Adverse Events
Incidence of all AEs and SAEs, including relationship to study device and severity.
Time frame: through study completion, an average of 12 weeks
Physician Acceptance Rate
Proportion of algorithm-generated recommendations accepted by the physician
Time frame: through the 4-week AI-Assisted Systme intervention
Physician Satisfaction with AI-Assisted System
Mean scores from a modified clinician satisfaction survey evaluating usability, reliability, and overall experience.
Time frame: the end of the 4-week AI-Assisted Systme intervention
Patient Treatment Satisfaction
Mean scores from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: the end of each 4-week intervention period
Percentage of Time with Glucose Above 13.9 mmol/L
Percentage of CGM readings above 13.9 mmol/L during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
Percentage of Time with Glucose Below 3.0 mmol/L
Percentage of CGM readings below 3.0 mmol/L during each 4-week crossover period.
Time frame: the last 2 weeks of each 4-week intervention period
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