Diabetes Mellitus, Type 1NCT04616391
AHCL System Initiation in T1D Patients naïve to Technology
A study testing insulin pump Medtronic 780G in people with Diabetes Mellitus, Type 1, run by Jagiellonian University.
Trial summary
The primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies. The trial is a two-centers, randomized controlled, parallel group study. Read more about this study
- Who is it for?
- Ages 26 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- insulin pump Medtronic 780G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2020to 1 Jul 2021
- Phase
- Interventional
- 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 26 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 26 - 60 years at time of screening a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Willing to participate in a study for the specified duration
- Willing to perform ≥ 4 finger stick blood glucose measurements daily
- Willing to perform required sensor calibrations
- Willing to wear the system continuously throughout the study
- Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
Show all 9Show fewer
- Treated with MDI
- Willing to perform at least 4 BGM/day, when on MDI
- At least communicative level of English to be able to understand the pump interface.
Who cannot join
- Previous treatment with CSII/CGM
- Usage of ultra-rapid insulins, e.g. FIASP
- concurrent illness
- laboratory abnormalities, or medications that might affect study participation,
- current pregnancy
- renal impairment
- hemoglobin A1c value above 10%.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transition of Patients With T1D From Multiple Daily Injection (MDI) and Self-Monitoring of Blood Glucose (SMBG) Directly to MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) System :Impact on Glucose Control and Quality of Life Measures
The primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies.
The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
Read the detailed description
Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including hybrid closed loop (HCL) systems.
Initial studies on the MiniMed 670G system, the first HCL system approved, have reported increased glycemic control in both adults and pediatrics, having experience with insulin pump therapy with or without experience of CGM technology. More recently it was shown shown even further improvement in glycemic control with the 670G system, in children and adolescents naïve to both pump and CGM technologies. This may be, at least partially, due to lack of willingness of patients to "let the algorithm work" based on their previous experience with CSII and CGM.
The investigators aim to evaluate the impact of an Advanced Hybrid Closed Loop (AHCL) system in adults naïve to pump and CGM technology. For this purpose the investigators target the population of T1DM individuals who are older than 26 years. The study will be conducted in Poland, where only individuals under the age of 26 are entitled to CSII/CGM reimbursement.
If the study succeeds in terms of improved glycemic patterns, quality of life and patients' acceptance, it may provide evidence for consideration in CSII/CGM reimbursement for this population.
Devices usage in the study:
Envision Pro device (CE-marked) will be used to collect CGM data in a retrospective manner. Envision Pro records up to 6 days of data. Patients will wear 2 consecutive Envision Pro devices both during the run-in phase and the at the end of the study phase, i.e. up to 12 days of data. The first Envision Pro device will be placed in the hospital and the second Envision Pro device will be placed by the patient at home, assisted by the study staff on the phone.
In addition, patients from the AHCL group will use the MiniMed 780G AHCL system (CE-marked). The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature. In short, the protocol inputs the current insulin program (MDI) and calculates a 10-20% reduction in total daily dose, with a 40/60 basal/bolus distribution in four or five basal rates. Insulin-to-carbohydrate ratio (ICR) settings utilize the formula of 300-450/total daily dose (TDD) and the formula of 90-110/TDD (mmol/L) with two CF settings; the nighttime CF factor is set 10-20% higher than the daytime CF. Active insulin is set time (3 h); suspend before low feature is turned on with a threshold of 3.0-3.8 mmol/L (55-70 mg/dL), and glucose target ranges from 5.0 to 7.2 mmol/L (90-130 mg/dL.
The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2.At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits.
At each visit, the glycemic control will be reviewed, and system settings re-assessed and adjusted as needed, including ICR, AIT and basal rates in Manual Mode.
The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
Study phase
Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system.
MDI group:
The patient continues MDI treatment as per routine procedures
- Visit 1 (day 0, can be combined with the randomization visit): BG meter data download, data review and optimization of MDI management.
- Visit 2 (Visit 1 + 14 days, window +/- 3 days): BG meter data download, data review and optimization of MDI management
- Visit 3 (Visit 2 + 14 days, window +/- 3 days): BG meter data download, data review and optimization of MDI management
- Visit 4 (Visit 3 + 28 days, window +/- 7 days): BG meter data download, data review and optimization of MDI management
- Visit 5 Visit 4 + 22 days, window +/- 7 days): BG meter data download, data review and optimization of MDI management, first professional CGM evaluation start.
- Visit 6 (Visit 5 + 6 days, window +3 days) - phone call: second professional CGM evaluation start.
- Visit 7 (Visit 9 + 6 days, window + 3 days): QoL questionnaire, blood sample for HbA1c lab test.
Professional CGM evaluation will be repeated for 6 days in cased less than 10 days data is available.
Study conclusion.
AHCL group:
- Visit 1 (day 0, can be combined with the randomization visit): the patient will get the pre-reading materials on the 780G system, to be read before Visit 2. CGM training and initiation.
- Visit 2 (Visit 1 + 1 day, window +7 days): 780G system training and initiation in Manual Mode.
- Visit 3 (Visit 2 +3 days, window +3 days): 780G system data download. Auto Mode readiness assessment. 780G system initiation in Auto Mode with AHCL control
- Visit 4 (Visit 3 + 3 days, window +1 day) - phone call: Auto Mode initiation follow-up.
- Visit 5 (Visit 4 + 7 days, window +/- 3 days): 780G system data download, therapy assessment and optimization
- Visit 6 (Visit 5 + 14 days, window +/- 3 days): 780G system data download, therapy assessment and optimization
- Visit 7 (Visit 6 + 28 days, window +/- 7 days): 780G system data download, therapy assessment and optimization
- Visit 8 (Visit 7 + 22 days, window +/- 7 days): 780G system data download, therapy assessment and optimization, first professional CGM evaluation start.
- Visit 9 (Visit 8 + 6 days, window +3 days) - phone call: second professional CGM evaluation start.
- Visit 10 (Visit 9 + 6 days, window + 3 days): 780G system data download, QoL questionnaire, blood sample for HbA1c lab test.
Professional CGM evaluation will be repeated for 6 days in cased less than 10 days data is available.
Study Conclusion
Study endpoints
- Between group comparison of data measured by CGM technology will be performed based on data collected by professional CGM in both groups.
- Between group comparison of Quality of Life.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- insulin pump Medtronic 780G
- Keywords
- Medtronic 780G, Continous glucose monitoring systems, Insulin pump, diabetes type 1
- 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.
insulin pump Medtronic 780GDevice
Patients from the AHCL group will use the MiniMed 780G AHCL system. This system is already CE-marked.
The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature (Visit 1).
The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2 with the settings in the below table. The Insulin to Carb ratio (ICR) and the Active Insulin Time (AIT) may be adjusted by the physician during the study. The glucose target may not be adjusted, unless in case of safety concerns. The patients may not adjust system settings without consulting with the physician.
At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits.
| Study group | Role | What they receive |
|---|---|---|
| MDI group: | No intervention | The patient continues MDI treatment as per routine procedures |
| AHCL group | Experimental | The patient will use MiniMed 780G AHCL system Receives: Device: insulin pump Medtronic 780G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group TIR difference
Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L).
Measured: Day 78-90
Secondary outcomes (6)
Between group TIR difference >70%
Between groups difference in the percentage of participants achieving TIR >70%
Measured: Day 78-90
Between group difference in the percentage of time spent:
- Between group difference in the percentage of time spent:
- in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L)
- in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L)
- in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)
- in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)
Measured: Day 78-90
Between group difference in the mean glucose level
Between group difference in the mean glucose level
Measured: Day 78-90
Between group difference in the glycemic variability measure by SD and CV
Between group difference in the glycemic variability measure by SD and CV
Measured: Day 78-90
Between group difference in the HbA1c levels
Between group difference in the HbA1c levels
Measured: Day 78-90
Between group difference in the Diabetes Quality of Life (QoL) questionnaire score
Between group difference in the Diabetes Quality of Life (QoL) questionnaire score
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start2 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Poland Spółka z ograniczoną odpowiedzialnością, University of Rzeszow
- Responsible party
- Principal investigator, Tomasz Klupa, Jagiellonian University
- Investigators
- Tomasz Klupa, Prof, Principal investigator, Hospital University; jagiellonian University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616391
- Sponsor's protocol ID
- 1072.61201.8.2020
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
PubMed 27629148Cordero TL, Garg SK, Brazg R, Bailey TS, Shin J, Lee SW, Kaufman FR. The Effect of Prior Continuous Glucose Monitoring Use on Glycemic Outcomes in the Pivotal Trial of the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technol Ther. 2017 Dec;19(12):749-752. doi: 10.1089/dia.2017.0208. Epub 2017 Nov 17.
PubMed 29148821Forlenza GP, Messer LH, Berget C, Wadwa RP, Driscoll KA. Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field. Curr Diab Rep. 2018 Sep 26;18(11):114. doi: 10.1007/s11892-018-1078-1.
PubMed 30259309Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol. 2020 Jun;57(6):681-687. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.
PubMed 31953687Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
PubMed 28118453Cyranka K, Matejko B, Juza A, Kiec-Wilk B, Krzyzowska S, Cohen O, Da Silva J, Lushchyk M, Malecki MT, Klupa T. Improvement of Selected Psychological Parameters and Quality of Life of Patients With Type 1 Diabetes Mellitus Undergoing Transition From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to the MiniMed 780G Advanced Hybrid Closed-Loop System: Post hoc Analysis of a Randomized Control Study. JMIR Form Res. 2023 Jan 24;7:e43535. doi: 10.2196/43535.
PubMed 36692945Cyranka K, Matejko B, Chrobak A, Dudek D, Kiec-Wilk B, Cyganek K, Witek P, Lushchyk M, Krzyzowska S, Malecki MT, Klupa T. Assessment of the spectrum of depression and bipolarity in patients with type 1 diabetes. Diabetes Metab Res Rev. 2023 Jan;39(1):e3583. doi: 10.1002/dmrr.3583. Epub 2022 Nov 6.
PubMed 36270020
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition of Patients With T1D From Multiple Daily Injection (MDI) and Self-Monitoring of Blood Glucose (SMBG) Directly to MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) System :Impact on Glucose Control and Quality of Life Measures
- ClinicalTrials.gov ID
- NCT04616391
- Acronym / sponsor ID
- 1072.61201.8.2020
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Medtronic 780G, Continous glucose monitoring systems, Insulin pump, diabetes type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Medtronic Poland Spółka z ograniczoną odpowiedzialnością, University of Rzeszow
- Study start
- 2 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 5 Nov 2020 (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 primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies.
The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
Detailed description
Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including hybrid closed loop (HCL) systems.
Initial studies on the MiniMed 670G system, the first HCL system approved, have reported increased glycemic control in both adults and pediatrics, having experience with insulin pump therapy with or without experience of CGM technology. More recently it was shown shown even further improvement in glycemic control with the 670G system, in children and adolescents naïve to both pump and CGM technologies. This may be, at least partially, due to lack of willingness of patients to "let the algorithm work" based on their previous experience with CSII and CGM.
The investigators aim to evaluate the impact of an Advanced Hybrid Closed Loop (AHCL) system in adults naïve to pump and CGM technology. For this purpose the investigators target the population of T1DM individuals who are older than 26 years. The study will be conducted in Poland, where only individuals under the age of 26 are entitled to CSII/CGM reimbursement.
If the study succeeds in terms of improved glycemic patterns, quality of life and patients' acceptance, it may provide evidence for consideration in CSII/CGM reimbursement for this population.
Devices usage in the study:
Envision Pro device (CE-marked) will be used to collect CGM data in a retrospective manner. Envision Pro records up to 6 days of data. Patients will wear 2 consecutive Envision Pro devices both during the run-in phase and the at the end of the study phase, i.e. up to 12 days of data. The first Envision Pro device will be placed in the hospital and the second Envision Pro device will be placed by the patient at home, assisted by the study staff on the phone.
In addition, patients from the AHCL group will use the MiniMed 780G AHCL system (CE-marked). The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature. In short, the protocol inputs the current insulin program (MDI) and calculates a 10-20% reduction in total daily dose, with a 40/60 basal/bolus distribution in four or five basal rates. Insulin-to-carbohydrate ratio (ICR) settings utilize the formula of 300-450/total daily dose (TDD) and the formula of 90-110/TDD (mmol/L) with two CF settings; the nighttime CF factor is set 10-20% higher than the daytime CF. Active insulin is set time (3 h); suspend before low feature is turned on with a threshold of 3.0-3.8 mmol/L (55-70 mg/dL), and glucose target ranges from 5.0 to 7.2 mmol/L (90-130 mg/dL.
The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2.At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits.
At each visit, the glycemic control will be reviewed, and system settings re-assessed and adjusted as needed, including ICR, AIT and basal rates in Manual Mode.
The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
Study phase
Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system.
MDI group:
The patient continues MDI treatment as per routine procedures
- Visit 1 (day 0, can be combined with the randomization visit): BG meter data download, data review and optimization of MDI management.
- Visit 2 (Visit 1 + 14 days, window +/- 3 days): BG meter data download, data review and optimization of MDI management
- Visit 3 (Visit 2 + 14 days, window +/- 3 days): BG meter data download, data review and optimization of MDI management
- Visit 4 (Visit 3 + 28 days, window +/- 7 days): BG meter data download, data review and optimization of MDI management
- Visit 5 Visit 4 + 22 days, window +/- 7 days): BG meter data download, data review and optimization of MDI management, first professional CGM evaluation start.
- Visit 6 (Visit 5 + 6 days, window +3 days) - phone call: second professional CGM evaluation start.
- Visit 7 (Visit 9 + 6 days, window + 3 days): QoL questionnaire, blood sample for HbA1c lab test.
Professional CGM evaluation will be repeated for 6 days in cased less than 10 days data is available.
Study conclusion.
AHCL group:
- Visit 1 (day 0, can be combined with the randomization visit): the patient will get the pre-reading materials on the 780G system, to be read before Visit 2. CGM training and initiation.
- Visit 2 (Visit 1 + 1 day, window +7 days): 780G system training and initiation in Manual Mode.
- Visit 3 (Visit 2 +3 days, window +3 days): 780G system data download. Auto Mode readiness assessment. 780G system initiation in Auto Mode with AHCL control
- Visit 4 (Visit 3 + 3 days, window +1 day) - phone call: Auto Mode initiation follow-up.
- Visit 5 (Visit 4 + 7 days, window +/- 3 days): 780G system data download, therapy assessment and optimization
- Visit 6 (Visit 5 + 14 days, window +/- 3 days): 780G system data download, therapy assessment and optimization
- Visit 7 (Visit 6 + 28 days, window +/- 7 days): 780G system data download, therapy assessment and optimization
- Visit 8 (Visit 7 + 22 days, window +/- 7 days): 780G system data download, therapy assessment and optimization, first professional CGM evaluation start.
- Visit 9 (Visit 8 + 6 days, window +3 days) - phone call: second professional CGM evaluation start.
- Visit 10 (Visit 9 + 6 days, window + 3 days): 780G system data download, QoL questionnaire, blood sample for HbA1c lab test.
Professional CGM evaluation will be repeated for 6 days in cased less than 10 days data is available.
Study Conclusion
Study endpoints
- Between group comparison of data measured by CGM technology will be performed based on data collected by professional CGM in both groups.
- Between group comparison of Quality of Life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
| Arm | Type | Receives |
|---|---|---|
| MDI group: | No intervention | –The patient continues MDI treatment as per routine procedures |
| AHCL group | Experimental | Device: insulin pump Medtronic 780GThe patient will use MiniMed 780G AHCL system |
Who may qualify
- Ages
- 26 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 26 - 60 years at time of screening a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Willing to participate in a study for the specified duration
- Willing to perform ≥ 4 finger stick blood glucose measurements daily
- Willing to perform required sensor calibrations
- Willing to wear the system continuously throughout the study
Key exclusion criteria (7 listed)
- Previous treatment with CSII/CGM
- Usage of ultra-rapid insulins, e.g. FIASP
- concurrent illness
- laboratory abnormalities, or medications that might affect study participation,
- current pregnancy
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 |
|---|---|---|
| insulin pump Medtronic 780GPatients from the AHCL group will use the MiniMed 780G AHCL system. This system is already CE-marked. The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature (Visit 1). The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2 with the settings in the below table. The Insulin to Carb ratio (ICR) and the Active Insulin Time (AIT) may be adjusted by the physician during the study. The glucose target may not be adjusted, unless in case of safety concerns. The patients may not adjust system settings without consulting with the physician. At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits. | Device | AHCL group |
Primary outcome
Between group TIR difference
Time frame: Day 78-90
Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L).
6 secondary outcomes
Between group TIR difference >70%
Time frame: Day 78-90
Between group difference in the percentage of time spent:
Time frame: Day 78-90
Between group difference in the mean glucose level
Time frame: Day 78-90
Between group difference in the glycemic variability measure by SD and CV
Time frame: Day 78-90
Between group difference in the HbA1c levels
Time frame: Day 78-90
Between group difference in the Diabetes Quality of Life (QoL) questionnaire score
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Results publication: PubMed 27629148Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
- Results publication: PubMed 29148821Cordero TL, Garg SK, Brazg R, Bailey TS, Shin J, Lee SW, Kaufman FR. The Effect of Prior Continuous Glucose Monitoring Use on Glycemic Outcomes in the Pivotal Trial of the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technol Ther. 2017 Dec;19(12):749-752. doi: 10.1089/dia.2017.0208. Epub 2017 Nov 17.
- Results publication: PubMed 30259309Forlenza GP, Messer LH, Berget C, Wadwa RP, Driscoll KA. Biopsychosocial Factors Associated With Satisfaction and Sustained Use of Artificial Pancreas Technology and Its Components: a Call to the Technology Field. Curr Diab Rep. 2018 Sep 26;18(11):114. doi: 10.1007/s11892-018-1078-1.
- Results publication: PubMed 31953687Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol. 2020 Jun;57(6):681-687. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.
- Results publication: PubMed 28118453Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
- Derived from this study: PubMed 36692945Cyranka K, Matejko B, Juza A, Kiec-Wilk B, Krzyzowska S, Cohen O, Da Silva J, Lushchyk M, Malecki MT, Klupa T. Improvement of Selected Psychological Parameters and Quality of Life of Patients With Type 1 Diabetes Mellitus Undergoing Transition From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to the MiniMed 780G Advanced Hybrid Closed-Loop System: Post hoc Analysis of a Randomized Control Study. JMIR Form Res. 2023 Jan 24;7:e43535. doi: 10.2196/43535.
- Derived from this study: PubMed 36270020Cyranka K, Matejko B, Chrobak A, Dudek D, Kiec-Wilk B, Cyganek K, Witek P, Lushchyk M, Krzyzowska S, Malecki MT, Klupa T. Assessment of the spectrum of depression and bipolarity in patients with type 1 diabetes. Diabetes Metab Res Rev. 2023 Jan;39(1):e3583. doi: 10.1002/dmrr.3583. Epub 2022 Nov 6.
- Individual participant dataSharing planned: No
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Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Tomasz Klupa, Prof principal investigator
Hospital University; jagiellonian University Medical College
Questions about this trial
What is this clinical trial studying?
A study testing insulin pump Medtronic 780G in people with Diabetes Mellitus, Type 1, run by Jagiellonian University.
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 9 inclusion and 7 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Bartłomiej Matejko, PhD (48124003552, b.matejko@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group TIR difference (time frame: Day 78-90). 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 NCT04616391, which also lists 7 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 5 Nov 2020.