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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6; Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Lucie Radovnická; Phone Number: +420777624793; Email: radovnickal@gmail.com
• Study Contact Backup: Name: Jiri Lastuvka; Phone Number: 1420477114202; Email: jiri.lastuvka@kzcr.eu

Study Locations

• Czechia
  • Usti Nad Labem, Czechia, 401 13
    • Recruiting
    • Lucie Radovnická
    • Contact: Lucie Radovnická; Phone Number: +420777624793; Email: radovnickal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients with Type 1 diabetes

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1 with Control IQ system; Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6	Device: Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6; type of hybrid close loop insulin delivery system; Other Names: Control IQ
Group 2 with SmartGuard system; MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4	Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4; type of hybrid close loop insulin delivery system; Other Names: SmartGuard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
tim spent in TIR	changes in percentage of time in range (%TIR, 70-180 mg/dL [3.9-10.0 mmol/L])	12 month
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
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
glycemic variability	glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD)	12 m,onth
mean sensor glucose value	mean sensor glucose value	12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Masaryk Hospital Usti nad Labem
• Investigators: Study Chair: Jiri Lastuvka, Masaryk Hospital

Publications and helpful links

General Publications

• 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 Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Type 1 diabetes mellitus; glycated hemoglobin; hybrid closed loop system for automatic insulin dosing
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Masaryk Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes