Diabetes Mellitus, Type 1NCT05924932
Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D
An observational study of Diabetes Mellitus, Type 1, run by Masaryk Hospital Usti nad Labem at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with Type 1 diabetes
Who may be able to join
- patients with T1D
- Type 1 diabetes for > 1 years
- ≥ 18 years old
- CSII (without HCL) or MDI
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Lucie Radovnická
Ústí nad Labem, 401 13
Lucie Radovnická, +420777624793, radovnickal@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6, MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
- Keywords
- Type 1 diabetes mellitus, hybrid closed loop system for automatic insulin dosing, glycated hemoglobin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6Device
Also called Control IQ
type of hybrid close loop insulin delivery system
MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4Device
Also called SmartGuard
type of hybrid close loop insulin delivery system
| Study group | Role | What they receive |
|---|---|---|
| group 1 with Control IQ system | Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6 Receives: 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 Receives: Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
The difference and changes in glycated hemoglobin (HbA1c, % DCCT [mmol/mol]) between baseline and at 12 months after using HCL.
Measured: 12 month
Secondary outcomes (5)
tim spent in TIR
changes in percentage of time in range (%TIR, 70-180 mg/dL [3.9-10.0 mmol/L])
Measured: 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])
Measured: 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])
Measured: 12 month
glycemic variability
glycemic variability expressed as the percentage coefficient of variation (%CV) and standard deviation (SD)
Measured: 12 m,onth
mean sensor glucose value
mean sensor glucose value
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Usti nad Labem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucie Radovnická, Masaryk Hospital Usti nad Labem
- Investigators
- Jiri Lastuvka, Study chair, Masaryk hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924932
- Sponsor's protocol ID
- Masaryk Hospital
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 33269551Bergenstal 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05924932
- Acronym / sponsor ID
- Masaryk Hospital
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes mellitus, hybrid closed loop system for automatic insulin dosing, glycated hemoglobin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Masaryk Hospital Usti nad LabemUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 with Control IQ system | – | Device: Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6 |
| Group 2 with SmartGuard system | – | Device: MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with Type 1 diabetes
Key inclusion criteria (4 listed)
- patients with T1D
- Type 1 diabetes for > 1 years
- ≥ 18 years old
- CSII (without HCL) or MDI
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6Also: Control IQtype of hybrid close loop insulin delivery system | Device | group 1 with Control IQ system |
| MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4Also: SmartGuardtype of hybrid close loop insulin delivery system | Device | Group 2 with SmartGuard system |
Primary outcome
glycated hemoglobin
Time frame: 12 month
The difference and changes in glycated hemoglobin (HbA1c, % DCCT [mmol/mol]) between baseline and at 12 months after using HCL.
5 secondary outcomes
tim spent in TIR
Time frame: 12 month
time spent in hypoglycemia
Time frame: 12 month
time spent in hyperglycemia
Time frame: 12 month
glycemic variability
Time frame: 12 m,onth
mean sensor glucose value
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Results publication: PubMed 33269551Leelarathna 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.
- Results publication: PubMed 33453783Bergenstal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Lastuvka study chair
Masaryk hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Masaryk Hospital Usti nad Labem at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie Radovnická (+420777624793, radovnickal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924932, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.