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RecruitingNCT05924932Updated Nov 3, 2023

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

An observational study in Diabetes Mellitus, Type 1, sponsored by Masaryk Hospital Usti nad Labem. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Masaryk Hospital Usti nad Labem · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1

Keywords

  • Type 1 diabetes mellitus
  • hybrid closed loop system for automatic insulin dosing
  • glycated hemoglobin
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult patients with Type 1 diabetes

Inclusion criteria

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

Exclusion criteria

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).
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

Interventions

  • DeviceTandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6

    type of hybrid close loop insulin delivery system

    Also known as: Control IQ

  • DeviceMiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4

    type of hybrid close loop insulin delivery system

    Also known as: SmartGuard

05

What researchers measure

Primary outcomes

  1. glycated hemoglobin

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

    Time frame: 12 month

Secondary outcomes

  1. tim spent in TIR

    changes in percentage of time in range (%TIR, 70-180 mg/dL \[3.9-10.0 mmol/L\])

    Time frame: 12 month

  2. time spent in hypoglycemia

    percentage of time spent in hypoglycemia (%TBR, \<70 mg/dL \[\<3.9 mmol/L\] and \<54 mg/dL \[\<3.0 mmol/L\])

    Time frame: 12 month

  3. time spent in hyperglycemia

    percentage of time spent in hyperglycemia (%TAR, \>180 mg/dL \[\>10.0 mmol/L\] and \>250 mg/dL \[\>13.9 mmol/L\])

    Time frame: 12 month

  4. glycemic variability

    glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD)

    Time frame: 12 m,onth

  5. mean sensor glucose value

    mean sensor glucose value

    Time frame: 12 month

Other outcomes

  1. 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.

    Time frame: 12 month

06

Study locations

1 of 1 sites recruiting
  • Lucie Radovnická
    Usti Nad Labem, 401 13, Czechia
    Recruiting
07

References and documents

Publications

  • 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. PubMed 33269551 ↗
  • 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. PubMed 33453783 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05924932
Lead sponsor
Masaryk Hospital Usti nad Labem
Responsible party
Lucie Radovnická (MD, Masaryk Hospital Usti nad Labem) — Principal investigator
First posted
Jun 29, 2023
Start date
Dec 1, 2022
Primary completion
Dec 1, 2023 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Nov 3, 2023

Study contacts

Lucie Radovnická
Contact
radovnickal@gmail.com
+420777624793
Jiri Lastuvka
Contact
jiri.lastuvka@kzcr.eu
1420477114202
Jiri Lastuvka
study chair · Masaryk hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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