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The efficacy and safety of fully closed-loop automated insulin delivery in hospitalized patients with hyperglycemia receiving enteral/parenteral nutrition

The efficacy and safety of fully closed-loop automated insulin pump in hospitalized adults with hyperglycemia receiving enteral/parenteral nutrition

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078746
Enrollment
Unknown
Registered
2023-12-18
Start date
2023-12-18
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

in-hospital hyperglycemia

Interventions

Test group A:Fully closed-loop automated insulin delivery technology
Test group B:Conventional subcutaneous insulin therapy

Sponsors

First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) agree to participate in the trial and sign the informed consent; 2) hospitalized patients with non-severe hyperglycemia receiving enteral/parenteral nutrition; 3) aged 18-55 years old; 4) need to receive subcutaneous insulin therapy; 5) glycosylated hemoglobin (HbA 1c) =12%; 6) Women of childbearing age must have a pregnancy test (ß-HCG) with a negative result before starting treatment, and both women of childbearing age and men (who have sex with women of childbearing age) must consent to the use of effective contraception.

Exclusion criteria

Exclusion criteria: Compliance with any one of the rules is excluded: 1) patients with gastroparesis, significant diabetic complications, recent acute macrovascular events, recent severe diabetic ketoacidosis or hypoglycemia, or receiving non-insulin antihyperglycemic drugs; 2) type 1 diabetes mellitus; 3) pregnancy and lactation; 4) current use of glucocorticoids or other drugs that may affect blood glucose; 5) participating in other clinical studies; 6) The investigator considered other conditions to be inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
time in range;

Secondary

MeasureTime frame
time above range, TAR;time beyond range;mean amplitude of glycemic excursions;

Countries

China

Contacts

Public ContactCai Yunying

First People's Hospital of Yunnan Province

maomao512@163.com+86 137 6916 5241

Outcome results

None listed

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