Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001288617
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
11/12/2023
Date last updated
11/12/2023
Date data sharing statement initially provided
11/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy and safety of a prototype ultra-low-cost insulin pump (ULCIP)
Scientific title
Clinical trial investigating the efficacy and safety of insulin delivery with a prototype ultra-low-cost insulin pump in adults with type 1 diabetes
Secondary ID [1] 310875 0
Nil known
Universal Trial Number (UTN)
U1111-1298-4492
Trial acronym
ULCIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus
331919 0
Condition category
Condition code
Metabolic and Endocrine 328650 328650 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This first-in-human feasibility study will assess the ability of a prototype ultra-low-cost insulin pump (ULCIP) to safely deliver insulin therapy. An ultra-low-cost insulin pump (ULCIP) developed at the Centre for Bioengineering (University of Canterbury) has been tested extensively to IEC 60601-2-24, the international testing standard which applies to insulin pumps. Bench side testing has demonstrated accuracy of insulin delivery comparable to commercially available insulin pumps.

This pump uses Medtronic consumables, a medtronic reservoir will be filled with insulin and a medtronic infusion set and cannula used to deliver insulin from the pump subcutaneously.

6 participants will complete a 4-8 day run-in period during which they use a Dexcom G7 continuous glucose monitor (CGM) while continuing their usual diabetes therapy at home. CGM data will be available to researchers. Participants will then the ULCIP for 9 hours in an inpatient clinical research facility, under the supervision of a diabetes physician and nurse. All 6 participants will use the ULCIP on the same day, adherence to the intervention will be determined by direct observation. The ULCIP will be used in manual mode, with basal rate, insulin sensitivity factor, and carbohydrate ratios programmed at the discretion of the study team based on insulin delivery and glucose data from the run-in period. Participants will consume two meals while using the ULCIP, each containing > 40 grams of carbohydrate. Study staff will assist participants in delivering a manual insulin bolus with the ULCIP, for each meal.

While using the ULCIP, participants will continue to use the Dexcom G7 CGM and will have venous blood samples obtained from an indwelling cannula hourly (every 60 minutes) (total of 10 samples). The CGM measures glucose every 5 minutes and transmits the result via Bluetooth in real-time. An alert will be generated for any CGM reading < 3.9 mmol/L or > 13.9 mmol/L, following which study staff will respond in accordance with a pre-defined safety plan. The safety plan includes administration of oral carbohydrate and/or IV dextrose for hypoglycaemia, administration of correction boluses via the ULCIP if required for hyperglycaemia and cessation of the ULCIP in the case of ketosis, with subsequent treatment of ketosis with insulin given by alternative device. Venous blood samples will be used to test glucose and beta-hydroxybutyrate on a point-of-care meter (CareSens Dual). The ULCIP will be discontinued if a participant has a beta-hydroxybutyrate result > 1.0 mmol/L. Serum insulin levels will be measured from the venous samples, on an assay validated for the detection of short-acting insulin analogues in order to monitor administered insulin.

After completion of 9 hours of use of the ULCIP participants will be assisted to transition back to their usual diabetes therapy.

Participants will be invited to participate in an optional focus group, which will be conducted either while using the ULCIP in the inpatient facility or in the subsequent 30 days in the department seminar room. The focus group will be about an hour but will be guided by the participants ensuring they have enough time to express their views. The focus group will be led by a diabetes nurse and aims to gain an understanding of the ULCIP device usability and attitudes towards ultra-low-cost diabetes technology. Participants will be able to elect to have a private interview either during the inpatient phase or in the 30 days following the inpatient phase if they feel uncomfortable participating in a group interview.
Intervention code [1] 327297 0
Treatment: Devices
Comparator / control treatment
Participants are their own control comparing run-in data to intervention data.
Control group
Active

Outcomes
Primary outcome [1] 336459 0
Time in range, defined as the percentage of the time that glucose is between 3.9 and 10.0 mmol/L.
Timepoint [1] 336459 0
Through the 4-8 day run-in period and throughout the 9-hour period of use of the ULCIP during the inpatient phase, day 6 (+/-2),
Primary outcome [2] 336538 0
Serum insulin concentration
Timepoint [2] 336538 0
Measured hourly during the 9-hour period of use of the ULCIP, day 6 (+/-2) , 10 time-points in total.
Secondary outcome [1] 428478 0
Determining device usability
Timepoint [1] 428478 0
During the inpatient phase, day 6 (+/- 2), after participants have used the novel device for more than 4 hours or up to 30 days after the inpatient phase as an outpatient,
Secondary outcome [2] 428630 0
Percentage of time blood glucose is >10 mmol/L
Timepoint [2] 428630 0
Through the 4-8 day run-in period and throughout the 9-hour period of use of the ULCIP during the inpatient phase, day 6 (+/-2),
Secondary outcome [3] 428631 0
Percentage of time blood glucose is less than 3.9 mmol/L
Timepoint [3] 428631 0
Through the 4-8 day run-in period and throughout the 9-hour period of use of the ULCIP during the inpatient phase, day 6 (+/-2),
Secondary outcome [4] 428632 0
Percentage of time blood glucose is less than 3.0 mmol/L
Timepoint [4] 428632 0
Through the 4-8 day run-in period and throughout the 9-hour period of use of the ULCIP during the inpatient phase, day 6 (+/-2),
Secondary outcome [5] 428633 0
Percentage time blood glucose in greater than 13.9 mmol/L
Timepoint [5] 428633 0
Through the 4-8 day run-in period and throughout the 9-hour period of use of the ULCIP during the inpatient phase, day 6 (+/-2),
Secondary outcome [6] 428635 0
Mean sensor glucose variability
Timepoint [6] 428635 0
Through the 4-8 day run-in period and throughout the 9-hour period of use of the ULCIP during the inpatient phase, day 6 (+/-2),
Secondary outcome [7] 428636 0
Serious adverse events (SAE), serious adverse device effects (SADE), adverse device effects (ADE), and device deficiencies (DD) as a composite secondary outcome
Timepoint [7] 428636 0
Day 6 (+/- 2), i.e. the inpatient phase while using the investigational device. Participants will be able to contact study staff in order to report any adverse effects throught the duration of the trial.
Secondary outcome [8] 428689 0
Serum beta-hydroxybutyrate
Timepoint [8] 428689 0
Measured hourly during the 9-hour period of use of the ULCIP, day 6 (+/- 2), 10 time-points in total
Secondary outcome [9] 428731 0
Total insulin dose programmed to be delivered by ULCIP during inpatient stay, further divided into basal insulin and bolus insulin delivery
Timepoint [9] 428731 0
During the 9-hour trial of the ULCIP on day 6 (+/-) 2,: Basal dose programmed over the 9-hour duration and boluses at meal times.

Eligibility
Key inclusion criteria
1. Type 1 diabetes as classified by the American Diabetes Association
2. Aged 18 years or older
3. Currently using insulin pump therapy for management of diabetes
4. Currently receiving basal insulin at a rate compatible with the investigational ultra-low-cost insulin pump
5. HbA1c < 97 mmol/mol (11.0%), based on the mean of all HbA1c results within the 6 months prior to the screening visit, or HbA1c at screening if no results are available
within the prior 6 months.
6. Willing and able to adhere to the study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A positive pregnancy test at screening is exclusionary
2. If female, is currently breastfeeding
3. Severe hypoglycaemia or diabetic ketoacidosis in the 6 months prior to study commencement.
4. Allergic or intolerant to Humalog® and NovoRapid® insulin
5. Alcohol or drug dependence (as reported by participants)
6. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
7. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the 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
Statistical methods / analysis
This is a first-in-human feasibility study to assess device safety and tolerability, therefore, no formal comparative statistical analyses are planned.

The focus group and any private interviews will be digitally recorded, transcribed, and thematic analysis will be conducted from the transcript.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/12/2023
Actual
Date of last participant enrolment
Anticipated
16/12/2023
Actual
Date of last data collection
Anticipated
17/12/2023
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 25944 0
New Zealand
State/province [1] 25944 0
Canterbury

Funding & Sponsors
Funding source category [1] 315136 0
University
Name [1] 315136 0
University of Canterbury
Country [1] 315136 0
New Zealand
Funding source category [2] 315147 0
University
Name [2] 315147 0
University of Otago
Country [2] 315147 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 317153 0
University
Name [1] 317153 0
University of Otago
Address [1] 317153 0
2 Riccarton Avenue Christchurch 8011
Country [1] 317153 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314074 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 314074 0
Ethics committee country [1] 314074 0
New Zealand
Date submitted for ethics approval [1] 314074 0
18/10/2023
Approval date [1] 314074 0
16/11/2023
Ethics approval number [1] 314074 0
2023 FULL 19050

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

Contacts
Principal investigator
Name 130314 0
A/Prof Martin de Bock
Address 130314 0
University of Otago Christchurch, 2 Riccarton Ave, Christchurch 8011
Country 130314 0
New Zealand
Phone 130314 0
+64 21 195 6579
Fax 130314 0
Email 130314 0
[email protected]
Contact person for public queries
Name 130315 0
Martin de Bock
Address 130315 0
University of Otago Christchurch, 2 Riccarton Ave, Christchurch 8011
Country 130315 0
New Zealand
Phone 130315 0
+64 21 195 6579
Fax 130315 0
Email 130315 0
[email protected]
Contact person for scientific queries
Name 130316 0
Martin de Bock
Address 130316 0
University of Otago Christchurch, 2 Riccarton Ave, Christchurch 8011
Country 130316 0
New Zealand
Phone 130316 0
+64 21 195 6579
Fax 130316 0
Email 130316 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
Privacy laws in New Zealand


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.