Skip to content

Comparison Between A Continuous Glucose Monitoring System and A Flashing Glucose Monitoring System as Blood Glucose Sources in A Do-It-Yourself Artificial Pancreas System: A single-center, open-label within-subject Crossover Study

Comparison Between A Continuous Glucose Monitoring System and A Flashing Glucose Monitoring System as Blood Glucose Sources in A Do-It-Yourself Artificial Pancreas System: A single-center, open-label within-subject Crossover Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028502
Enrollment
Unknown
Registered
2019-12-23
Start date
2019-12-15
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

Gold Standard:DexcomTM G5 sensor

Sponsors

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. T1D; 2. Aged 7-75 years; 3. Baseline HbA1c 8IU/day, required basal rate every hour; 5. Managing to operate a cell phone, having access to Wi-Fi and is willing to share information in AndroidAPS to a cloud-based remote monitoring system during the study period; 6. Having complete record of demographic and clinical data in the retrospective phase, willing to donate continuous glucose monitoring data; 7. Agreed to participate in the study and signed an informed consent.

Exclusion criteria

Exclusion criteria: 1. Any serious diseases potentially interfering with the study; 2. Use of oral antidiabetic agents or acetaminophen; 3. Active sexual life without use of contraception, or pregnancy

Design outcomes

Primary

MeasureTime frame
Change of HbA1c level;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
CGM data: a. Mean blood glucose value b. % Time 3.9–7.8 mmol/L (TIT) c. % Time 3.9–10.0 mmol/L (TIR) d. % Time 10.0 mmol/L g. % Time>13.9 mmol/L h. SD, CV, MAGE, MODD, M100 index, J-index, GRADE (whole), LBGI and HBGI of CGM values;Quality of life (1. Chinese Version Hypoglycemia Fear Survey II-Worry Scale); 2. Diabetes Distress Scale; 3. EQ-5D-5L questionnaire);1. Food Frequency Questionnaire;Food Diary (photos);

Countries

China

Contacts

Public ContactJianping Weng?Sihui Luo

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

wengjp@vip.163.com+86 13903000303

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026