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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
AI-Assisted Insulin Pump Settings Optimization System
DeviceA 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.
Conventional Insulin Pump Therapy
DeviceSensor-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.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Inpatient AI OptimizationExperimental treatment 1 intervention
Group B: Home AI-First (Sequence A)Experimental treatment 1 intervention
Group C: Home Control-First (Sequence B)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time-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 periodSecondary outcomes
1
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 period2
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 period3
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 period4
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 periodSponsors and contacts
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Source ClinicalTrials.gov