AHCL System Initiation in T1D Patients naïve to Technology
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
1 other identifier
interventional
40
0 countries
N/A
Brief 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. Patients will be followed up during approximatively 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2020
CompletedStudy Start
First participant enrolled
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedNovember 5, 2020
November 1, 2020
5 months
October 29, 2020
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Day 78-90
Secondary Outcomes (6)
Between group TIR difference >70%
Day 78-90
Between group difference in the percentage of time spent:
Day 78-90
Between group difference in the mean glucose level
Day 78-90
Between group difference in the glycemic variability measure by SD and CV
Day 78-90
Between group difference in the HbA1c levels
Day 78-90
- +1 more secondary outcomes
Other Outcomes (3)
Number of severe hypoglycemic episodes
Day 90
Number of Diabetic Ketoacidosis events
Day 90
Number of Severe Hyperglycemia episodes
Day 90
Study Arms (2)
MDI group:
NO INTERVENTIONThe patient continues MDI treatment as per routine procedures
AHCL group
EXPERIMENTALThe patient will use MiniMed 780G AHCL system
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jagiellonian Universitylead
- Medtronic Poland Spółka z ograniczoną odpowiedzialnościącollaborator
- University of Rzeszowcollaborator
Related Publications (7)
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.
PMID: 27629148RESULTCordero 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.
PMID: 29148821RESULTForlenza 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.
PMID: 30259309RESULTPetrovski 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.
PMID: 31953687RESULTBeck 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.
PMID: 28118453RESULTCyranka 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.
PMID: 36692945DERIVEDCyranka 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.
PMID: 36270020DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tomasz Klupa, Prof
Hospital University; jagiellonian University Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 5, 2020
Study Start
November 2, 2020
Primary Completion
March 31, 2021
Study Completion
July 1, 2021
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share