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Trial registered on ANZCTR


Registration number
ACTRN12624000200583p
Ethics application status
Submitted, not yet approved
Date submitted
15/01/2024
Date registered
29/02/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Automated insulin delivery to optimise current care for Maori and Pacific peoples living with type 1 diabetes
Scientific title
Automated insulin delivery to optimse current care for Maori and Pacific peoples living with type 1 diabetes: Investigating the impact on glycaemic control
Secondary ID [1] 311325 0
Protocol number: 0006-AHCL
Universal Trial Number (UTN)
U1111-1302-6746
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 332576 0
Condition category
Condition code
Metabolic and Endocrine 329273 329273 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 3-month single-arm study followed by a 9-month extension phase investigating advanced hybrid closed loop (AHCL) in Maori and Pacific adults with type 1 diabetes (T1D) and suboptimal glycaemic control that have previously not been using closed loop therapy. Following baseline assessments of blinded continuous glucose monitoring (CGM) for 14 days (using Guardian sensor and transmitter CGM system), all participants will undergo a run-in period of 72 hours running as sensor augmented pump (SAP) with predictive low glucose monitoring (PLGM) to allow subjects to familiarize with the system and for control to be optimized, and will then enter into a 3-month study period of using the insulin pump in its trial settings with the SmartGuardTM feature enabled (i.e., in Auto Mode). All participants will use the AHCL system with SmartGuardTM for a further 9 months during the extension phase. While participants have the option to enable/disable SmartGuardTM during the study, the AHCL system provides optimal results in Auto Mode and therefore participants are encouraged to keep the system in Auto Mode during the study. Expected duration of participant involvement is approx. 13 months (14 days baseline assessments, 3 days run-in, 12 months intervention period).
The study intervention is the Medtronic MiniMed™ 780G BLE 2.0 AHCL insulin pump running in SmartGuardTM mode. In use with the continuous glucose monitoring (CGM) component (Medtronic's newest DS5 CGM system), the MiniMed™ 780G BLE 2.0 AHCL pump is capable of continuous insulin delivery at set and variable rates, and the 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 this data so that it can be retrospectively analysed. The MiniMed™ AHCL insulin pump also includes the closed loop algorithm as part of the SmartGuard™ collection of features. SmartGuard™ is comprised of Manual Mode Low Management, which includes the Suspend On Low feature (suspends insulin delivery when a pre-set low sensor glucose [SG] threshold is reached), the Suspend Before Low feature (enables insulin to suspend 30 minutes before a pre-set low SG threshold is reached) and Auto Mode (hybrid closed loop) feature. The pump can also be used as a simple pump without CGM or as a SAP without use of the SmartGuard™ features. When Auto Mode is enabled, the sensor glucose values (SGVs) 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 patient, at five-minute intervals, to achieve glycaemic control. With the AHCL system, subjects must still deliver bolus insulin for meals. In addition, the setting for active insulin must be programmed. Basal rates are set for periods of Manual Mode (open loop) therapy. When Auto Mode is not enabled, the user may use the Smart Guard™ Low Management features. Here, basal rate delivery will be suspended either when the SG has reached a programmed low threshold (Suspend on Low) or before the SGV has reached the programmed low threshold (Suspend before Low).
Participants will receive face-to-face education at the study site by trained study staff (research nurses with diabetes knowledge who are insulin pump education specialists) based on the manufacturer's user guides. The initial educational session will take approximately 5-6 hours, including the device set-up of the pump. Participants’ pump data will be automatically uploaded to CareLinkTM through the MiniMed™ Mobile phone app, which will be installed on participants’ phones and is connected with the pump via Bluetooth. The app uploads data every 24 hours into the cloud, 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. Remote reviews will happen daily for 7 days after initiation of AHCL, then weekly for 6 weeks, then monthly until the end of study. Personalised pump setting changes/refinements can be insulin basal rates, active insulin time, and insulin-to-carbohydrate-ratios, if required, and will be verified by the investigative staff by way of electronic review of the pump upload with the new settings.
Intervention code [1] 327767 0
Treatment: Devices
Comparator / control treatment
This is a single-arm study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337093 0
Glycaemic control as measured by glycated hemoglobin (HbA1C) from blood samples.
Timepoint [1] 337093 0
At baseline, and at 3 (primary endpoint), 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [1] 430649 0
Glycaemic control as measured by percentage of time in range (3.9 – 10mmol/L).
Timepoint [1] 430649 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [2] 430650 0
Glycaemic outcomes via CGM data for % CGM time below 3.0mmol/L
Timepoint [2] 430650 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [3] 430651 0
Glycaemic outcomes via CGM data for % CGM time below 3.9mmol/L
Timepoint [3] 430651 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [4] 430652 0
Glycaemic outcomes via CGM data for % CGM time above 10.0mmol/L
Timepoint [4] 430652 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [5] 430653 0
Glycaemic outcomes via CGM data for % CGM time above 13.9mmol/L
Timepoint [5] 430653 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [6] 430654 0
Glucose levels during the day (0600-2359 hours).
Timepoint [6] 430654 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [7] 430655 0
Glucose levels during the night (0000-0559 hours).
Timepoint [7] 430655 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [8] 430656 0
Safety of AHCL system.
Timepoint [8] 430656 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [9] 430657 0
Safety of AHCL system
Timepoint [9] 430657 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [10] 430658 0
The change in fear of hypoglycaemia
Timepoint [10] 430658 0
At baseline, and at 3 months postintervention phase commencement.
Secondary outcome [11] 430659 0
The change in diabetes treatment satisfaction
Timepoint [11] 430659 0
At baseline, and at 3 months postintervention phase commencement.
Secondary outcome [12] 430660 0
The change in diabetes treatment satisfaction
Timepoint [12] 430660 0
At 3 months postintervention phase commencement.
Secondary outcome [13] 430661 0
The change in sleep quality
Timepoint [13] 430661 0
At baseline, and at 3 months postintervention phase commencement.
Secondary outcome [14] 430662 0
The change in diabetes impact and device satisfaction
Timepoint [14] 430662 0
At baseline, and at 3 months postintervention phase commencement.
Secondary outcome [15] 430663 0
Platform performance as measured by percentage of time spent in automode,
Timepoint [15] 430663 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [16] 430664 0
Platform performance as measured by percentage of time of sensor wear
Timepoint [16] 430664 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [17] 430665 0
Platform performance as measured by percentage of insulin delivery distribution.
Timepoint [17] 430665 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [18] 430666 0
Platform performance as measured by alarm frequency
Timepoint [18] 430666 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.
Secondary outcome [19] 430667 0
Glycaemic control as measured by percentage of time in tight range (3.9 – 7.8mmol/L).
Timepoint [19] 430667 0
At baseline, and at 3, 6, 9, and 12 months postintervention phase commencement.

Eligibility
Key inclusion criteria
1. Adults of Maori or Pacific ethnicity, any gender, aged 16 – 65 years inclusive on day of consent.
2. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
3. Current HbA1c level of greater than or equal to 8.0% (64 mmol/mol).
4. Minimum daily insulin requirement (total daily dose [TDD]) of greater than or equal to 8 units.
5. Willing and able to adhere to the study protocol.
6. Access to the internet and a computer system that meets requirements for uploading the study pump.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous use of automated insulin delivery technology prior to baseline visit.
2. 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.
3. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
4. Current use of Metformin, SGLT-2 or GLP-1 medications.
5. 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.
6. Known moderate to severe diabetic retinopathy.
7. If participant is of child-bearing potential, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
8. 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.

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
The primary outcome is the mean change in HbA1c from baseline to 13 weeks of AHCL use (primary endpoint). Additional outcomes include standard glycaemic metrics, time in SmartGuard, safety, and psychosocial variables using Poisson and linear mixed models as appropriate. Analyses will be undertaken in Stata (StataCorp, Texas) by the study biostatistician (or supervised by the study biostatistician) with two-sided p < 0.05 considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26077 0
New Zealand
State/province [1] 26077 0

Funding & Sponsors
Funding source category [1] 315576 0
Government body
Name [1] 315576 0
NZ Lottery Grants Board
Country [1] 315576 0
New Zealand
Funding source category [2] 315578 0
University
Name [2] 315578 0
University of Otago
Country [2] 315578 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street Dunedin North Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317672 0
None
Name [1] 317672 0
Address [1] 317672 0
Country [1] 317672 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314474 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314474 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 314474 0
New Zealand
Date submitted for ethics approval [1] 314474 0
12/01/2024
Approval date [1] 314474 0
Ethics approval number [1] 314474 0

Summary
Brief summary
Despite modern treatment, complications of type 1 diabetes (T1D) and a reduced life expectancy continue to be a reality for patients. Irrespective of socioeconomic status, Maori and Pacific people are particularly over-represented in suboptimal health outcomes, which is evident shortly following diagnosis and remains predictive for long-term complications. These groups may have the most to gain from newer automated technologies. To test our hypothesis that automation of insulin delivery via AHCL will safely facilitate improvements in glycaemic control and reduce disease burden in Maori and Pacific adults with out-of-target glycaemic control and naïve to closed loop therapy, 20 Maori and Pacific participants, aged 16 – 65 years, with current HbA1c of greater than or equal to 64 mmol/mol will use AHCL for 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131710 0
Prof Benjamin J Wheeler
Address 131710 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 131710 0
New Zealand
Phone 131710 0
+64 3 470 9189
Fax 131710 0
Email 131710 0
ben.wheeler@otago.ac.nz
Contact person for public queries
Name 131711 0
Prof Benjamin J Wheeler
Address 131711 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 131711 0
New Zealand
Phone 131711 0
+64 3 470 9189
Fax 131711 0
Email 131711 0
ben.wheeler@otago.ac.nz
Contact person for scientific queries
Name 131712 0
Prof Benjamin J Wheeler
Address 131712 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 131712 0
New Zealand
Phone 131712 0
+64 3 470 9189
Fax 131712 0
Email 131712 0
ben.wheeler@otago.ac.nz

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.