Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000907549
Ethics application status
Approved
Date submitted
11/07/2024
Date registered
25/07/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
25/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Next Generation Automated Insulin Delivery in Children and Adults with Type 1 Diabetes
Scientific title
Effectiveness and safety of a Novel Medtronic Experimental Automated Insulin Delivery (NMX-AID) system in children and adults with type 1 diabetes
Secondary ID [1] 311327 0
0005-AHCL
Universal Trial Number (UTN)
U1111-1302-6776
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 332580 0
Condition category
Condition code
Metabolic and Endocrine 329278 329278 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week multiphase single site and single arm clinical trial. The co-primary objectives of this exploratory study are to investigate the safety and effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery (NMX-AID) system in children (2 – 17 years, inclusive) and adults (18 years and older) with type 1 diabetes over a duration of up to 9 weeks. For baseline data collection, participants will be trained in the use of MiniMed™ 780G AHCL system with Guardian 4 sensors and Guardian Link 4 transmitters (Medtronic) and wear this system for 3 weeks (NB: All participants in this study will have prior experience using the MiniMed 770G/780G system).
Following the 3-week baseline data collection, participants will undergo NMX-AID system training (approx. 5 hours) and use the system for up to 9 weeks (duration dependent on participant age as described below). Study enrolment will be staggered by age groups, with adults (aged 18 years and older) starting first, followed by children aged 7-17 years, and lastly children aged 2-6 years, as described below:

- Adults (aged 18 years and older) will be the first cohort to commence the study. Following training on the NMX-AID system, adult participants will use the system for 9 weeks at home.
- Children 7 to 17 years of age (inclusive) will commence the study following study completion of adult participants and no detection of safety concerns (severe hypoglycaemia or diabetic ketoacidosis attributable to NMX-AID system wear).
Immediately following training on the NMX-AID system, children aged 7-17 years (together with a parent/guardian) will enter a supervised hotel phase for 5 days/4 nights. Constant on-site supervision will be provided by health care professionals (HCP; medical and nursing staff), including overnight monitoring using CareLinkâ„¢ Clinical App, which allows for remote data monitoring from a HCP's study smartphone. Following the supervised hotel phase, participants will use the NMX-AID system for up to 9 weeks at home, with support from their parent/guardian.
- Children 2-6 years of age (inclusive) will commence the study following study completion of children aged 7-17 years and no detection of safety concerns (severe hypoglycaemia or diabetic ketoacidosis attributable to NMX-AID system wear). Children aged 2-6 years will follow identical study procedures as described for children ages 7-17 years above.

The NMX-AID system is capable of continuous insulin delivery, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. When used with the continuous glucose monitoring (CGM) components (Simplera Sync), the insulin pump is capable of continuous or periodic monitoring of glucose levels via a sensor that is inserted in the interstitial fluid under the skin, including the detection of possible low or high blood glucose episodes. The pump also displays glucose values, storing the data so that it can be retrospectively analysed to track patterns and improve diabetes management. The NMX-AID system has the capability to operate in Manual Mode (also referred to as open loop) or in Auto Mode (also referred to as closed loop). While users have the option to manually announce meals to the system, the closed loop algorithm of the NMX-AID system enables the auto-delivery of meal insulin boluses without user input or acknowledgement. When Auto Mode is enabled, the sensor glucose (SG) value received by the pump from the CGM system will be used to automatically calculate the required insulin dose. It will then deliver insulin to the user, at five-minute intervals, to achieve glycaemic control. Basal rates are set for periods of Manual Mode (open loop) therapy. When Auto Mode is not enabled, the user may use the Low Management features. Here, basal rate delivery will be suspended either when the SG has reached a programmed low glucose threshold (Suspend on Low) or before the SG has reached the programmed low glucose threshold (Suspend before Low).

Participants will receive face-to-face education at the study site by trained study staff (research nurses or diabetes educators with diabetes knowledge who are insulin pump trainers) based on the manufacturer's user guides. The initial educational session will take approximately 4-5 hours, including the device set-up of the pump. All participants will be monitored remotely by study staff during at-home NMX-AID system use. Monitoring will occur in form of review of system data uploads via CareLink™ software and phone calls with participants or parents/guardians (as applicable). Participants’ pump data will be automatically uploaded to CareLink™ through the MiniMed™ Mobile phone app, which will be installed on participants’ phones and is connected with the pump via Bluetooth, every 24 hours, where study staff can review the data and give feedback to refine pump settings if necessary. These refinements are personalised based on the participant’s uploaded data and will happen after each review of the uploaded pump data.
Intervention code [1] 327770 0
Treatment: Devices
Comparator / control treatment
This is a single-arm study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338532 0
Glycaemic control as measured by percentage of time in range 3.9 – 10mmol/L.
Timepoint [1] 338532 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Primary outcome [2] 338533 0
Glycaemic control as measured by percentage of time below 3.9 mmol/L.
Timepoint [2] 338533 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [1] 436294 0
Glycaemic control as measured by percentage of time below 3.0 mmol/L.
Timepoint [1] 436294 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [2] 436295 0
Glycaemic control as measured by percentage of time above 10.0 mmol/L.
Timepoint [2] 436295 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [3] 436296 0
Glycaemic control as measured by percentage of time above 13.9 mmol/L.
Timepoint [3] 436296 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [4] 436297 0
Glycaemic control as measured by percentage of time in range 3.9 to 7.8 mmol/L.
Timepoint [4] 436297 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [5] 436298 0
Glycaemic control as measured by glycated hemoglobin (HbA1c) from blood samples.
Timepoint [5] 436298 0
At baseline, and at the end of the study 9 weeks post-intervention commencement.
Secondary outcome [6] 436299 0
The change in fear of hypoglycaemia
Timepoint [6] 436299 0
At baseline, and at the end of the study 9 weeks post-intervention commencement.
Secondary outcome [7] 436300 0
The change in diabetes impact and device satisfaction.
Timepoint [7] 436300 0
At baseline, and at the end of the study 9 weeks post-intervention commencement.
Secondary outcome [8] 436301 0
Glucose levels during the day (0600-2359 hours).
Timepoint [8] 436301 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [9] 436302 0
Glucose levels during the night (0000 to 0559 hours).
Timepoint [9] 436302 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [10] 436303 0
Safety of NXG-AID system
Timepoint [10] 436303 0
Continuously from start of baseline to end of study 9 weeks post-intervention commencement.
Secondary outcome [11] 436304 0
Safety of NXG-AID system
Timepoint [11] 436304 0
Continuously from start of baseline to end of study 9 weeks post-intervention commencement.
Secondary outcome [12] 436305 0
Platform performance as measured by percentage of time of sensor wear
Timepoint [12] 436305 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [13] 436306 0
Platform performance as measured by percentage of insulin delivery distribution.
Timepoint [13] 436306 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [14] 436307 0
Platform performance as measured by percentage of time spent in automode,
Timepoint [14] 436307 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [15] 436308 0
Platform performance as measured by alarm frequency.
Timepoint [15] 436308 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [16] 436309 0
Platform performance as measured by amount of carbohydrates entered.
Timepoint [16] 436309 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [17] 437430 0
Glycaemic control as measured by coefficient of variation.
Timepoint [17] 437430 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [18] 437431 0
Glycaemic control as measured by sensor glucose concentration.
Timepoint [18] 437431 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [19] 437432 0
Glycaemic control as measured by proportion of participants meeting the glycaemic target of spending equal to or greater than 70% of time in range 3.9 – 10mmol/L.
Timepoint [19] 437432 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.
Secondary outcome [20] 437433 0
Glycaemic control as measured by proportion of participants meeting the glycaemic target of having a glycated hemoglobin (HbA1c) result of less than 53mmol/mol.
Timepoint [20] 437433 0
At baseline, and at 9 weeks post-intervention commencement.
Secondary outcome [21] 437434 0
Glycaemic control as measured by proportion of participants meeting the glycaemic target of spending less than 4% of time below 3.9mmol/L.
Timepoint [21] 437434 0
At baseline, and at the 3, 6, and 9 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
1. Male or female aged 2 years or older on day of consent.
2. Type 1 diabetes as per the American Diabetes Association Classification.
3. Duration of diabetes at least 12 months prior to Study Day 1 (or 6 months for those <7 years).
4. HbA1c of equal to or greater than 6.5% (48 mmol/mol) on day of consent.
5. Previous experience with 770G/780G systems for at least 3 months prior to study start.
6. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units/day.
7. Willing and able to adhere to the study protocol.
8. Adults aged 18 years or older with access to the internet and a computer system that meets requirements for uploading the study pump (willingness to attend clinic for upload is possible if no other option).
9. Children aged 2-17 years (inclusive) with at least one parent/legal guardian willing and able to upload system data as per preceding criterion, and proficient in basic diabetes management.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous significant adverse event at investigator discretion that precludes the participant safely using advanced diabetes technology/sensors e.g., unable to wear glucose sensors due to prior cutaneous adverse events.
2. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
3. Current use of Metformin, SGLT-2 or GLP-1 medications.
4. History or current evidence of severe psychiatric disorder, uncontrolled seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), or severe visual impairment that in the opinion of the Investigator would limit study involvement or be a safety issue.
5. Moderate to severe diabetic retinopathy.
6. If participant is of child-bearing potential, is pregnant or becomes pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
7. Any clinically significant pre-existing medical condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
8. Planned travel either outside New Zealand, or in remote areas within New Zealand that would hinder study system data uploads.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
21/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 26376 0
New Zealand
State/province [1] 26376 0

Funding & Sponsors
Funding source category [1] 315580 0
Commercial sector/Industry
Name [1] 315580 0
Medtronic Inc.
Country [1] 315580 0
United States of America
Primary sponsor type
Government body
Name
Health New Zealand - Southern
Address
Country
New Zealand
Secondary sponsor category [1] 319180 0
None
Name [1] 319180 0
Address [1] 319180 0
Country [1] 319180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314476 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314476 0
Ethics committee country [1] 314476 0
New Zealand
Date submitted for ethics approval [1] 314476 0
12/01/2024
Approval date [1] 314476 0
23/02/2024
Ethics approval number [1] 314476 0
2024 FULL 19434

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

Contacts
Principal investigator
Name 131718 0
Prof Benjamin J Wheeler
Address 131718 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 131718 0
New Zealand
Phone 131718 0
+64 274701980
Fax 131718 0
Email 131718 0
[email protected]
Contact person for public queries
Name 131719 0
Benjamin J Wheeler
Address 131719 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 131719 0
New Zealand
Phone 131719 0
+64 274701980
Fax 131719 0
Email 131719 0
[email protected]
Contact person for scientific queries
Name 131720 0
Benjamin J Wheeler
Address 131720 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 131720 0
New Zealand
Phone 131720 0
+64 274701980
Fax 131720 0
Email 131720 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.