Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000244404
Ethics application status
Approved
Date submitted
19/02/2025
Date registered
4/04/2025
Date last updated
4/04/2025
Date data sharing statement initially provided
4/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of a Combined Insulin-Delivery and Glucose Sensory System and Patch Pump System in Persons with Type 1 Diabetes
Scientific title
Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of the SynerG TM CGM sensor Integrated with the Niia Essential Insulin Patch Pump System in Persons with Type 1 Diabetes.
Secondary ID [1] 314003 0
None
Universal Trial Number (UTN)
Trial acronym
SMART01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 336735 0
Condition category
Condition code
Metabolic and Endocrine 333233 333233 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, non-randomised, single-centre, feasibility study.
The participants will have an experimental combined insulin cannula and glucose sensor (Synergy) delivering insulin integrated with a novel Insulin Patch Pump (Pharmasens Niia Essential patch pump system). There is no control device. The participants will also have a Dexcom G6 Continuous glucose Monitor (CGM) system inserted.

It is the first human clinical trial to be conducted with this system. Insulin delivery will be operated manually via the patch pump by trained study personnel. There will be no closed- or hybrid closed loop system in operation.

The study will consist of two phases: Firstly a pilot phase, and secondly the main three day study phase.

The device is inserted using sterile non-touch technique and with the assistance of an insertion device to ensure the glucose sensing cannula sits in the subcutaneous tissue.

PILOT PHASE:
Three participants will use the investigational device for 12 hours. The patch pump and integrated SynerG CGM Sensor will be inserted by trained study personnel. During this time there will be one meal test. The meal test will last 4-5 hours with 15 minutely interval blood sampling. Trained study staff will manually operate the insulin patch pump to administer insulin.
After achieving stable glucose elves the systems will be removed and participants will resume their usual diabetes management.
Participants involved in the pilot phase will not be involved in the main phase.

MAIN PHASE
15 participants will wear the investigational devices for 72 hours spread across four consecutive calendar days. During this extended monitoring period, each participant will undergo two meal tests in the clinical trials centre on days 1 and 3, with free living days in between and until the end of the study period. During the free living period, participants will stay at a hotel near the clinic with study staff onsite. Study staff will manually operate insulin pumps to deliver insulin and CGM glucose levels will be monitored remotely by trained study staff. Participants will perform fingerpick glow glucose measurements throughout the day (fasting, preprandial/2-h postprandial at each meal, bedtime) or when required (suspected hypoglycaemia, suspected technical failure of CGM, etc.). The study staff will be available at the hotel promptly whenever needed..

MEAL TESTS
The meal tests in both the pilot phase and the main phase, participants will arrive to the clinical trials centre at 7am after an overnight fast. After insertion of investigational devices (if required), participants will consume a standardised carbohydrate breakfast of 30-60g of carbohydrate. 15 minutely venous blood samples will be taken to monitor blood glucose levels. Meal tests will last over 4-5 hours.

After 72 hours, all study devices will be removed, and participants will resume normal diabetes management with their personal devices.

Experimental device CGM data will be collected throughout the study period. Experimental device CGM accuracy will be compared with reference Yellow Springs Instruments (YSI) blood glucose level (BGL) as well as commercially available Dexcom G6 CGM readings.

Training of the device will be provided to study staff by Pharmasens with 2 hours of face to face practical training 1 week prior to enrolment of the first participant.

Adherence to the intervention is assessed by direct observation of participants and measurement of blood glucose levels.
Intervention code [1] 330587 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340797 0
Glucose Sensor Accuracy
Timepoint [1] 340797 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Primary outcome [2] 340798 0
Glucose sensor accuracy
Timepoint [2] 340798 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Secondary outcome [1] 445097 0
Glucose sensor Accuracy
Timepoint [1] 445097 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Secondary outcome [2] 445098 0
Glucose Sensor Accuracy
Timepoint [2] 445098 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Secondary outcome [3] 445144 0
Glucose Sensor Accuracy
Timepoint [3] 445144 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Secondary outcome [4] 445145 0
Glucose Sensor Accuracy
Timepoint [4] 445145 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Secondary outcome [5] 445146 0
Glucose Sensor Accuracy
Timepoint [5] 445146 0
PILOT PHASE: During the mixed meal test MAIN PHASE: During the mixed meal tests on days 1 and 3. Experimental device glucose sensor readings (which will be continuous glucose readings) will be compared to 15 minutely blood samples tested via YSI glucose analyser and finger test strips during the mixed meal tests - over a 4-5 hour period on those days.
Secondary outcome [6] 445147 0
Insulin Set Survival
Timepoint [6] 445147 0
Infusion set failure defined by any of the above over a 72 hour period, from insertion (day 1) to end of trial. Primary timepoint would be 72 hours, to see if in the infusion set lasts the full 72 hours. Glucose readings will be done via continuous glucose monitoring on the experimental device. Blood ketone readings will be done during mixed meal tests if the patients blood glucose is greater than 13.9 mmol/L and/or the participant is nauseated or vomiting.
Secondary outcome [7] 445586 0
Infusion Set Survival
Timepoint [7] 445586 0
Infusion set failure defined by any of the above over a 72 hour period, from insertion (day 1) to end of trial. Primary timepoint would be 72 hours, to see if in the infusion set lasts the full 72 hours. Glucose readings will be done via continuous glucose monitoring on the experimental device. Blood ketone readings will be done during mixed meal tests if the patients blood glucose is greater than 13.9 mmol/L and/or the participant is nauseated or vomiting.
Secondary outcome [8] 445587 0
Infusion Set Survival
Timepoint [8] 445587 0
Infusion set failure defined by any of the above over a 72 hour period, from insertion (day 1) to end of trial. Primary timepoint would be 72 hours, to see if in the infusion set lasts the full 72 hours. Glucose readings will be done via continuous glucose monitoring on the experimental device. Blood ketone readings will be done during mixed meal tests if the patients blood glucose is greater than 13.9 mmol/L and/or the participant is nauseated or vomiting.
Secondary outcome [9] 445588 0
Infusion set survival
Timepoint [9] 445588 0
Infusion set failure defined by any of the above over a 72 hour period, from insertion (day 1) to end of trial. Primary timepoint would be 72 hours, to see if in the infusion set lasts the full 72 hours. Glucose readings will be done via continuous glucose monitoring on the experimental device. Blood ketone readings will be done during mixed meal tests if the patients blood glucose is greater than 13.9 mmol/L and/or the participant is nauseated or vomiting.

Eligibility
Key inclusion criteria
• Adults aged 18-75
• Type 1 diabetes of a least 6 months duration
• HbA1C <10%
• Usage of CSII therapy and GCM for at least 3 months
• An understanding of and willingness to follow the protocol and sign the informed consent
• Willing to use Lispro during the study participation
• Average daily insulin dose of participants is between 30 IU/d and 75 IU/d
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe hypoglycaemia resulting in seizure or loss of consciousness in the 3 months prior to enrolment
• Significantly impaired awareness of hypoglycaemia
• History or high risk of ketoacidosis within the last 12 months
• Female participants: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use an acceptable form of contraception during the study (for sexually active participants of childbearing potential)
• History of frequent catheter abscesses associated with pump therapy
• Participants currently taking or who have taken within the last 3 months any non-insulin
hypoglycaemic agents, including but not limited to: Metformin, Sodium-glucose co-
transporter inhibitors (SGLT2i), Glucagon-like peptide-1 inhibitors (GLP-1 inh)
• Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the participant, e.g. seizure disorder, adrenal
disorder, dialysis for renal failure, cystic fibrosis, active infection
• Any incapacity or general condition that, in the opinion of the investigator, prevents
adequate compliance with the study procedures, e.g. mental or visual incapacity, language
barriers, alcohol or drug misuse
• Know allergies against adhesives

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/03/2025
Date of last participant enrolment
Anticipated
5/05/2025
Actual
Date of last data collection
Anticipated
9/05/2025
Actual
Sample size
Target
18
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27657 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 43831 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 318510 0
Commercial sector/Industry
Name [1] 318510 0
Pacific Diabetes Technology
Country [1] 318510 0
United States of America
Funding source category [2] 318524 0
Commercial sector/Industry
Name [2] 318524 0
Pharmasens
Country [2] 318524 0
Switzerland
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne Human Research Ethics Commitee
Address
Country
Australia
Secondary sponsor category [1] 320918 0
None
Name [1] 320918 0
Address [1] 320918 0
Country [1] 320918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317115 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317115 0
Ethics committee country [1] 317115 0
Australia
Date submitted for ethics approval [1] 317115 0
03/12/2024
Approval date [1] 317115 0
04/03/2025
Ethics approval number [1] 317115 0
278/24

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

Contacts
Principal investigator
Name 140042 0
Prof David O'Neal
Address 140042 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC, 3065
Country 140042 0
Australia
Phone 140042 0
+61 425731665
Fax 140042 0
Email 140042 0
[email protected]
Contact person for public queries
Name 140043 0
Ms Catriona Sims
Address 140043 0
University of Melbourne, Department of Medicine, 41 Victoria Parade, Fitzroy, VIC, 3065
Country 140043 0
Australia
Phone 140043 0
+61 417482010
Fax 140043 0
Email 140043 0
[email protected]
Contact person for scientific queries
Name 140044 0
David O'Neal
Address 140044 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VIC, 3065
Country 140044 0
Australia
Phone 140044 0
+61 425731665
Fax 140044 0
Email 140044 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.