Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.
This study is a single-center, open-label, 1:1 randomized controlled exploratory trial. Participants were randomly allocated via complete randomization into two groups: the experimental group (hybrid closed-loop insulin delivery system) and the control group (using identical hardware devices, with the experimental group operating in closed-loop mode while the control group in open-loop mode). The intervention duration ranged from 5 to 7 days, adjusted based on glycemic control status, aiming to compare the efficacy and clinical benefits of hybrid closed-loop insulin delivery versus insulin pumps combined with CGM for glycemic management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.
Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.
Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011
Changsha, Hunan, China
RECRUITINGCGM-measured Time in Range (TIR 5.6-10.0 mmol/L)
The difference in percentage of time spent within target glucose range (5.6-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.
Time frame: Up to 28 days
Time above range (TAR) >10.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \> 10.0 mmol/L between group
Time frame: Up to 28 days
Time above range (TAR) >20.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \> 20.0 mmol/L between group
Time frame: Up to 28 days
Time below range (TBR) <5.6 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \<5.6 mmol/L between groups
Time frame: Up to 28 days
Time below range (TBR) < 3.9 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \<3.9 mmol/L between groups
Time frame: Up to 28 days
Time below range (TBR) < 3.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \<3.0 mmol/L between groups
Time frame: Up to 28 days
Time below range (TBR) < 2.8 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \<2.8 mmol/L between groups
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Time frame: Up to 28 days
CGM-measured Mean Glucose Level
CGM-measured mean glucose level between groups
Time frame: Up to 28 days
CGM-measured Glucose Standard Deviation (SD)
The difference in the CGM-measured glucose standard deviation between groups. Standard Deviation represents how much glucose levels fluctuate over time from a given average.
Time frame: Up to 28 days
CGM-Measured Glucose Coefficient of Variation (CV)
The difference in the CGM-measured glucose coefficient of variation (CV) between groups. The CV is calculated as the ratio of the standard deviation to the mean glucose values for each participant, derived from CGM data.
Time frame: Up to 28 days
CGM-Measured Glucose Risk Index (GRI)
The CGM-measured glucose risk index (GRI) between groups. GRI is a comprehensive metric derived from CGM data, designed to quantify the overall risk associated with blood glucose variability. It integrates multiple aspects of glucose levels, including the frequency and severity of both hypo- and hyperglycemic events, as well as the duration of time spent outside the target glucose range.
Time frame: Up to 28 days
Insulin dose
The difference in the insulin dose between groups
Time frame: Up to 28 days
Preoperative optimization duration (days)
The difference in the preoperative optimization duration between groups
Time frame: Up to 28 days
Time in range (TIR) 4.4-10.0 mmol/L
The difference in percentage of time spent within target glucose range (4.4-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.
Time frame: Up to 28 days