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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924932
• Other study ID #: Masaryk Hospital
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Masaryk Hospital Usti nad Labem
• Contact: Lucie Radovnická
• Phone: +420777624793
• Email: radovnickal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6
type of hybrid close loop insulin delivery system
• MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
type of hybrid close loop insulin delivery system

Locations

Country	Name	City	State
Czechia	Lucie Radovnická	Usti Nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Usti nad Labem

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Stu — View Citation

Leelarathna L, Choudhary P, Wilmot EG, Lumb A, Street T, Kar P, Ng SM. Hybrid closed-loop therapy: Where are we in 2021? Diabetes Obes Metab. 2021 Mar;23(3):655-660. doi: 10.1111/dom.14273. Epub 2020 Dec 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and Tolerability	the incidence of severe hypoglycemia (requiring third-party assistance to treat), ketoacidosis requiring hospitalization, skin reaction, infection, or hematoma at the site of insertion of the sensor.	12 month
Primary	glycated hemoglobin	The difference and changes in glycated hemoglobin (HbA1c, % DCCT [mmol/mol]) between baseline and at 12 months after using HCL.	12 month
Secondary	tim spent in TIR	changes in percentage of time in range (%TIR, 70-180 mg/dL [3.9-10.0 mmol/L])	12 month
Secondary	time spent in hypoglycemia	percentage of time spent in hypoglycemia (%TBR, <70 mg/dL [<3.9 mmol/L] and <54 mg/dL [<3.0 mmol/L])	12 month
Secondary	time spent in hyperglycemia	percentage of time spent in hyperglycemia (%TAR, >180 mg/dL [>10.0 mmol/L] and >250 mg/dL [>13.9 mmol/L])	12 month
Secondary	glycemic variability	glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD)	12 m,onth
Secondary	mean sensor glucose value	mean sensor glucose value	12 month