Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001076662p
Ethics application status
Submitted, not yet approved
Date submitted
5/09/2023
Date registered
9/10/2023
Date last updated
9/10/2023
Date data sharing statement initially provided
9/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a New Medtronic Experimental Automated Insulin Delivery (Artificial Pancreas) System
Scientific title
Evaluation of the Feasibility of a Novel Medtronic Experimental Automated Insulin Delivery System In Adults With Type 1 Diabetes
Secondary ID [1] 310543 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 331367 0
Condition category
Condition code
Metabolic and Endocrine 328114 328114 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this research study is to demonstrate feasibility and to generate initial data to evaluate safety, user acceptance and system efficacy of the Novel Medtronic Experimental Automated Insulin Delivery (NMX-AID) system in adults with type 1 diabetes. The NMX-AID system includes a Medtronic 780G insulin pump with updated software, a factory-calibrated ‘DS5’ continuous glucose sensor, and an extended wear infusion set. A sequential before and after study design will be undertaken in four stages, with data analysis occurring to compare data between stages. User perception of the technology will be assessed at the end of Run-in and at the end of each study stage with a validated questionnaire (Insulin Delivery System Rating Questionnaire-Short Form). Continuous glucose sensor data and insulin delivery data will be collected from the study devices throughout the study and monitored for safety and for adherence by the study staff/diabetes educators. A semi-structured interview to assess participants’ perceptions of NMX-AID will be implemented at the end of the study.

Participation in this research will occur over approximately 12-16 weeks. Fifteen participants with type 1 diabetes, with at least three months experience with the Minimed 780G will be recruited. Following informed consent, a baseline clinical history will be obtained, and physical examination performed. Adjustment of all device settings may occur throughout all study stages. Device education and review will be performed by accredited diabetes nurse educators.

The schedule of the four stages is as follows, with further details regarding study visits provided thereafter:
Run-in: Participants will commence a three-to-four-week run-in using an updated Medtronic 780g system (BLE2.0 Advanced Hybrid Closed-loop (HCL) system), with user-initiated meal boluses performed 15 minutes prior to eating. The last 14 days of Run-in prior to Stage 1 will serve as baseline glucose control reference. Run-in will last a minimum of three weeks and will not exceed four weeks. The duration of this stage will be dependent on achieving stable device data for the final 2 weeks of the stage, as determined by the investigators.
Stage 1: Progression to stage 1 will begin immediately following run-in. All participants will be provided with the NMX-AID system and educated in its use, which will occur in small groups of ~4 people. They will use the device after activating the PumpStart function, enabling immediate AID activation and will announce all meals or snacks by initiating a bolus of insulin approximately 15 minutes before any food. Stage 1 will last a minimum of three weeks and will not exceed four weeks. The duration of this stage will be dependent on achieving stable device data for the final 2 weeks of the stage, as determined by the investigators.
Stage 2: Progression to stage 2 will begin immediately following stage 1. All participants will use the NMX-AID system as a full closed loop system where meals will be unannounced (they will be requested not to bolus for any meals) though they will be permitted to correct elevated glucose readings and modify the AID target in preparation for exercise. Stage 2 will last a minimum of three weeks and will not exceed four weeks. The duration of this stage will be dependent on achieving stable device data for the final 2 weeks of the stage, as determined by the investigators.
Stage 3: Progression to stage 3 will begin immediately following stage 2. All participants will continue to use the NMX-AID system and will be advised to bolus as they see fit. Stage 3 will last a minimum of three weeks and will not exceed four weeks. The duration of this stage will be dependent on achieving stable device data for the final 2 weeks of the stage, as determined by the investigators.


The study will require five study visits, with a minimum of 3 face-to-face visits and 2 visits which may occur remotely.

The initial visit will be face-to-face and involve screening and provision of BLE2 devices, and will last approximately 2 hours. After enrollment, participants will be screened with demographic data recorded and a clinical history and physical examination will be performed. Carbohydrate counting knowledge will be reviewed. Guidelines will be provided for correction of hyperglycaemia. Blood will be collected for HbA1c and electrolytes. Participants with Minimed 780G experience who have passed screening will be provided with and educated in the use of the BLE2 system (insulin pumps and sensors) and extended wear insulin infusion sets (EWIS). They will commence Run-in which will last three to four weeks. During Run-in participants will be asked to bolus / administer rapid acting insulin approximately 15 minutes prior to each meal (announced meal-time insulin).
The second visit will also be face-to-face, will take approximately 4-6 hours and will involve commencement of Stage 1. All BLE2 insulin pumps and sensors will be collected from participants. Questionnaires will be administered to all participants. All participants will be provided with and trained in the use of NMX-AID pumps and associated sensors. All will be advised to continue to announce meals with an insulin bolus for the 3-4 week duration of Stage 1.
The third visit can occur remotely, will last approximately 30mins and will involve commencement of Stage 2. Questionnaires will be administered to all participants. Participants will continue the use of NMX-AID devices but will be advised not to bolus for meals nor for corrections for the 3-4 week duration of Stage 2.
The fourth visit can also occur remotely, will take approximately 30mins and will involve commencement of Stage 3. Questionnaires will be administered to all participants. Participants will continue the use of NMX-AID devices but will be able to decide if a pre-meal bolus is required or not for the 3-4 week duration of Stage 3.
The fifth and final visit will involve the End-of Study Visit, will take approximately 4-6 hours and will occur face-to-face. Questionnaires will be administered. All study devices will be collected. The participants will return to their usual care after their own device settings have been reviewed. Semi-Structured interviews will be conducted. A blood sample will be collected for measurement of HbA1c.
Intervention code [1] 326935 0
Treatment: Devices
Comparator / control treatment
The interventional treatment (Novel Experimental Automated Insulin Delivery system [NMX-AID]) will be benchmarked against the participants' previous use with the Medtronic 780g BLE2.0 system, with a crossover study design.

Participants will use BLE2.0 for the first 3-4 weeks of the study (run-in) which will act as a comparator for the NMX-AID system, used in Stage 1 (weeks ~4-8), Stage 2 (weeks ~8-12) and Stage 3 (weeks ~12-16). NMX-AID used in each stage will be compared with data from BLE2.0 used in the run-in phase.
Control group
Active

Outcomes
Primary outcome [1] 335988 0
Percentage of time spent with sensor glucose levels greater than 13.9mmol/l
Timepoint [1] 335988 0
CGM outcomes will be collected for the final two weeks of Run-in (2-4 weeks post-enrolment) as well as the final 2 weeks of each Stage (Stages 1 (6-8 weeks post-enrolment), 2 (10-12 weeks post-enrolment) and 3 (14-16 weeks post-enrolement)).
Primary outcome [2] 336194 0
Semi-structured interviews will occur to assess feasibility of the NMX-AID system, including subjective data regarding participant expectations, effectiveness of the system with regards to sleep, cognition, exercise, driving and overall.
Timepoint [2] 336194 0
The interview will occur at the end of the study (week 16 post-enrolment).
Secondary outcome [1] 426386 0
User satisfaction will be measured via the Insulin Delivery System Rating Questionnaire
Timepoint [1] 426386 0
The questionnaire will be administered at the end of each stage; Run-in (4 weeks post-enrolment), Stage 1 (8 weeks post-enrolment), 2 (12 weeks post-enrolment) and Stage 3 (16 weeks post-enrolment).
Secondary outcome [2] 426387 0
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each Stage, including:
CGM % time spent in target glycaemia ([a] 3.9-10.0 mmol/L).
Timepoint [2] 426387 0
CGM outcomes will be collected for the final two weeks of Run-in (2-4 weeks post-enrolment) as well as the final 2 weeks of each Stage (Stages 1 (6-8 weeks post-enrolment), 2 (10-12 weeks post-enrolment) and 3 (14-16 weeks post-enrolment)).
Secondary outcome [3] 427281 0
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each Stage, including:
CGM % time spent in tighter target glycaemia (3.9-7.8 mmol/L)
Timepoint [3] 427281 0
CGM outcomes will be collected for the final two weeks of Run-in (2-4 weeks post-enrolment) as well as the final 2 weeks of each Stage (Stages 1 (6-8 weeks post-enrolment), 2 (10-12 weeks post-enrolment) and 3 (14-16 weeks post-enrolment)).
Secondary outcome [4] 427282 0
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each Stage, including:
% time spent in hyperglycaemia (>10.0 mmol/L).
Timepoint [4] 427282 0
CGM outcomes will be collected for the final two weeks of Run-in (2-4 weeks post-enrolment) as well as the final 2 weeks of each Stage (Stages 1 (6-8 weeks post-enrolment), 2 (10-12 weeks post-enrolment) and 3 (14-16 weeks post-enrolment)).
Secondary outcome [5] 427283 0
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each Stage, including:
CGM % time spent in hypoglycaemia (<3.9 mmol/L).
Timepoint [5] 427283 0
CGM outcomes will be collected for the final two weeks of Run-in (2-4 weeks post-enrolment) as well as the final 2 weeks of each Stage (Stages 1 (6-8 weeks post-enrolment), 2 (10-12 weeks post-enrolment) and 3 (14-16 weeks post-enrolment)).
Secondary outcome [6] 427284 0
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each Stage, including:
CGM % time spent in severe hypoglycaemia (<3.0 mmol/L).
Timepoint [6] 427284 0
CGM outcomes will be collected for the final two weeks of Run-in (2-4 weeks post-enrolment) as well as the final 2 weeks of each Stage (Stages 1 (6-8 weeks post-enrolment), 2 (10-12 weeks post-enrolment) and 3 (14-16 weeks post-enrolment)).

Eligibility
Key inclusion criteria
Age > 18 years;
T1D of >1 year duration;
stable on Medtronic Minimed 780G system pump therapy for >3 months;
proficient in carbohydrate counting;
HbA1c <10.0%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or planned pregnancy;
eGFR<40;
a history of diabetic ketoacidosis in the last 3 months;
diabetic gastroparesis;
tape allergy
major medical or psychiatric illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314745 0
Commercial sector/Industry
Name [1] 314745 0
Medtronic
Country [1] 314745 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
35 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 316730 0
None
Name [1] 316730 0
Address [1] 316730 0
Country [1] 316730 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313755 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313755 0
Ethics committee country [1] 313755 0
Australia
Date submitted for ethics approval [1] 313755 0
22/08/2023
Approval date [1] 313755 0
Ethics approval number [1] 313755 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129254 0
Prof David O'Neal
Address 129254 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 129254 0
Australia
Phone 129254 0
+61 3 92882012
Fax 129254 0
Email 129254 0
[email protected]
Contact person for public queries
Name 129255 0
Dale Morrison
Address 129255 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 129255 0
Australia
Phone 129255 0
+61 3 92314164
Fax 129255 0
Email 129255 0
[email protected]
Contact person for scientific queries
Name 129256 0
Dale Morrison
Address 129256 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 129256 0
Australia
Phone 129256 0
+61 413137853
Fax 129256 0
Email 129256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.