Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Meal insulin dose adjustment by AI-assisted
The study proposes an artificial pancreas-like algorithm (AP-A) that automatically determines the appropriate pre-prandial insulin dose based on intermitten
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic subjects receiving intensive insulin therapy 2. Aged >= 18 years old 3. Poor blood sugar control, HbA1c>=8.0%
Exclusion criteria
Exclusion criteria: 1. The subject is currently pregnant, intends to become pregnant, or is unwilling and unable to use contraception during the study (female only) 2. Abnormal mental state 3. Refuse to wear invasive examination equipment 4. There are clear reasons for not wearing dynamic glucose monitoring (severe allergies, skin diseases, etc.) 5. The subject has symptoms and signs such as skin lesions, scarring, redness, infection or edema at the sensor application site that will affect the sensor application or the accuracy of the interstitial fluid glucose measurement 6. Complicated serious diseases, including but not limited to heart disease, cerebrovascular disease, liver and kidney disease, severe diabetes-related complications 7. The subject has an appointment for X-ray, MRI or CT examination during the study period, and the appointment cannot be changed to before the start of the study or after the end of the study 8. Drugs that affect blood sugar such as glucocorticoids have been used within one month 9. Any other reasons judged by the investigator that would make the subject unsuitable to participate in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose in target range time measured using isCGM for glucose level during the insulin titration period (depending on how long the participants need multiple daily injections therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum glycated albumin level measured using a standard laboratory test 14 days after enrollment, last visit 2. The proportion of glucose data 10.0mmol/L measured using isCGM during insulin titration 5. The proportion of glucose data >13.3mmol/L measured using isCGM during insulin titration 6. The area under the curve of glucose <10.0mmol/L in the AGP map measured using isCGM during insulin titration 7. The area under the curve of glucose <3.9mmol/L in the AGP map measured using isCGM during insulin titration 8. Average glucose data measured using isCGM during insulin titration 9. The standard deviation of glucose data measured using isCGM during insulin titration 10. The difference between the dose approved by the doctor and the dose recommended by the algorithm measured using the insulin dosage record during the titration period 11. The number of times that the doctor recommended the dose in the experimental group is different from that recommended by the algorithm measured using the insulin dosage record during the titration period 12. In the experimental group, the proportion of blood glucose in the range of 3.9mmol/L to 10.0mmol/L within 4 hours after insulin injection when there was a difference between the doctor-approved dose and the algorithm-recommended dose measured using the insulin dosage record during the titration period | — |
Countries
China
Contacts
Public ContactWei Liu
Outcome results
None listed