NCT05924932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

June 21, 2023

Last Update Submit

November 1, 2023

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes mellitushybrid closed loop system for automatic insulin dosingglycated hemoglobin

Outcome Measures

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.

    12 month

Secondary Outcomes (5)

  • tim spent in TIR

    12 month

  • time spent in hypoglycemia

    12 month

  • time spent in hyperglycemia

    12 month

  • glycemic variability

    12 m,onth

  • mean sensor glucose value

    12 month

Other Outcomes (1)

  • Safety and Tolerability

    12 month

Study Arms (2)

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

Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6DEVICE

type of hybrid close loop insulin delivery system

Also known as: Control IQ
group 1 with Control IQ system
MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4DEVICE

type of hybrid close loop insulin delivery system

Also known as: SmartGuard
Group 2 with SmartGuard system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients with Type 1 diabetes

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucie Radovnická

Ústí nad Labem, 401 13, Czechia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33269551RESULT

  • 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.

    PMID: 33453783RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for measurement of glycated hemoglobin

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jiri Lastuvka

    Masaryk hospital

    STUDY CHAIR

Central Study Contacts

Lucie Radovnická

CONTACT

+420777624793radovnickal@gmail.com

Jiri Lastuvka

CONTACT

1420477114202jiri.lastuvka@kzcr.eu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

May 1, 2024

Last Updated

November 3, 2023

Record last verified: 2023-11

Locations

CZ(1)