Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4

• Registration Number: NCT05924932
• Lead Sponsor: Masaryk Hospital Usti nad Labem

Brief Summary

The goal of this study is compare the effect of hybrid closed loop system (HCL) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (T1D) in patient with different initial glycated hemoglobin.

Detailed Description

Rationale for the Study:

According to our hypothesis, even T1D patients with an initially optimal glucose level should benefit from this treatment method in the form of a reduction in glycemic variability.

There are very few clinical studies from real practice in a larger group of patients.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03
• Primary Completion: 2023-12-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients with T1D
• Type 1 diabetes for > 1 years
• ≥ 18 years old
• CSII (without HCL) or MDI

Exclusion Criteria

• Severe noncompliance
• Known severe diabetic retinopathy and/or macular edema,
• Lactation, pregnancy, or intending to become pregnant during the study;
• A condition likely to require MRI. Use of acetaminophen-containing medication;
• Unwillingness to use the study device for >70% of time.
• Conditions that affect red blood cell turnover (hemolytic and other anemias, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoesis, end-stage kidney disease).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 with SmartGuard system	MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4	MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4

Primary Outcome Measures

Name	Time	Method
glycated hemoglobin	12 month	The difference and changes in glycated hemoglobin (HbA1c, % DCCT \[mmol/mol\]) between baseline and at 12 months after using HCL.

Secondary Outcome Measures

Name	Time	Method
time spent in hyperglycemia	12 month	percentage of time spent in hyperglycemia (%TAR, \>180 mg/dL \[\>10.0 mmol/L\] and \>250 mg/dL \[\>13.9 mmol/L\])
tim spent in TIR	12 month	changes in percentage of time in range (%TIR, 70-180 mg/dL \[3.9-10.0 mmol/L\])
glycemic variability	12 m,onth	glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD)
time spent in hypoglycemia	12 month	percentage of time spent in hypoglycemia (%TBR, \<70 mg/dL \[\<3.9 mmol/L\] and \<54 mg/dL \[\<3.0 mmol/L\])
mean sensor glucose value	12 month	mean sensor glucose value

Trial Locations

Locations (1)

Lucie Radovnická; 🇨🇿 Usti Nad Labem, Czechia