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Trial registered on ANZCTR


Registration number
ACTRN12622000190707
Ethics application status
Approved
Date submitted
18/01/2022
Date registered
3/02/2022
Date last updated
1/11/2022
Date data sharing statement initially provided
3/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study to assess a new Dexcom algorithm for fully automated insulin delivery in adults with diabetes
Scientific title
First in human feasibility study; automated insulin delivery utilizing the Dexcom next generation algorithm in adults with diabetes
Secondary ID [1] 306209 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 324916 0
Type 2 diabetes mellitus 328102 0
Condition category
Condition code
Metabolic and Endocrine 322350 322350 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a new, next generation, algorithm for automated insulin delivery developed by Dexcom (inControl Auto). This is a closed loop system using a Dexcom G6 continuous glucose monitor, Ypsomed insulin pump, and Google Pixel Android handset. Unlike previous hybrid systems (where users need to announce meals with an estimation of carbohydrate content of a meal), this algorithm is fully automated and aims to maximise time in sensor glucose range (3.9-10.0 mmol/L) without the need for meal announcement. Study participants will have their diabetes treated by this algorithm for a 12-week period.

Under the control of the algorithm, insulin will be delivered continuously by the Ypsomed pump. The dosage of insulin will be individualised to the patient (by the algorithm) in order to maximise the time that sensor-detected glucose is in the target range (3.9-10.0 mmol/L). The devices (Dexcom G6 continuous glucose monitor and Ypsomed insulin pump) will be continuously active throughout the 12-week period, as will the algorithm under investigation. The automated nature of the system means that no user input is required from participants other than wearing the device. Participant adherence will be verified through review of device data (glucose recordings and recorded insulin delivery).

Qualitative interviews will be held with a sub-group of participants within the 14-day run-in period and within 14 days of the participant completing the study, to gain understanding of the factors important to quality of life for participants; the impact of living with diabetes on those important factors; and the impact of the novel intervention on both diabetes and broader quality of life. Interviews will be held using an electronic platform that works for both investigator and participant. Experienced qualitative researchers who have conducted a number of diabetes studies and are mindful of the complexities associated with diabetes and its psychosocial impact will conduct the interviews. Interviews will be held with a sub-group of participants, n=10-12 in total. A purposive sampling approach will be taken to ensure representation across participants in terms of ethnicity, gender, diabetes duration, age.
Intervention code [1] 322611 0
Treatment: Devices
Intervention code [2] 322612 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330117 0
Sensor glucose time in range, defined as percentage of time 3.9-10.0 mmol/L as measured by continuous glucose monitor, calculated separately for day (0600-2359hrs), night (0000-0559hrs), and overall (24hrs)
Timepoint [1] 330117 0
14 days continuous glucose monitor data at end of intervention period (days 70-84), compared to 14 days of continuous glucose monitor data during initial 14-day run-in period
Primary outcome [2] 330118 0
Hypoglycaemia, defined as percentage of time glucose < 3.9 and < 3.0 mmol/L as measured by continuous glucose monitor, calculated separately for day (0600-2359hrs), night (0000-0559hrs), and overall (24hrs)
Timepoint [2] 330118 0
14 days continuous glucose monitor data at end of intervention period (days 70-84), compared to 14 days of continuous glucose monitor data during initial 14-day run-in period
Primary outcome [3] 330119 0
Hyperglycaemia, defined as percentage of time glucose > 10.0 and > 13.9 mmol/L as measured by continuous glucose monitor, calculated separately for day (0600-2359hrs), night (0000-0559hrs), and overall (24hrs)
Timepoint [3] 330119 0
14 days continuous glucose monitor data at end of intervention period (days 70-84), compared to 14 days of continuous glucose monitor data during initial 14-day run-in period
Secondary outcome [1] 404940 0
Quality of life, as measured by self-administered INSPIRE questionnaires developed to evaluate impact of AID systems and the psychosocial functioning and quality of life of individuals with type 1 diabetes.
Timepoint [1] 404940 0
At baseline and at study end (after 12-week intervention completed)
Secondary outcome [2] 404941 0
One-to-one semi-structured interviews will be conducted using the SEIQoL interview framework, to gain understanding of the factors important to quality of life for participants; the impact of living with diabetes on those important factors; and the impact of the novel intervention on both diabetes and broader quality of life.
Timepoint [2] 404941 0
Interviews will be held during the 14-day run-in period and within 14 days of the participant completing the study (after the 12-week intervention).
Secondary outcome [3] 405596 0
Quality of life, as measured by self-administered EQ-5D-5L questionnaire developed to measure health status
Timepoint [3] 405596 0
At baseline and at study end (after 12-week intervention completed)

Eligibility
Key inclusion criteria
1. Type 1 or type 2 diabetes mellitus, diagnosed > 6 months prior to the screening visit
2. Have never used an automated insulin delivery system
3. HbA1c 58 mmol/mol or greater within the 6 months prior to the screening visit
4. Total daily basal insulin requirement compatible with basal rate allowed by inControl Auto algorithm
5. Willing and able to adhere to the study protocol
6. Have daily access to a Wi-Fi network
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or planning to become pregnant while participating in the study
2. Alcohol or drug dependence (as reported by participants)
3. Severe visual impairment that would impair use of the devices
4. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
5. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study
6. Allergic or intolerant of Humalog® and NovoRapid® insulin

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
Safety/efficacy
Statistical methods / analysis
Data produced will generate mean and standard deviation data which can be used in power calculations in future planned randomized control trials. As this is a feasibility first in human study, outcomes are exploratory and descriptive. Therefore, power calculations for statistical purposes are not required. An initial study population n = 20 was chosen as the optimal sample size for defining a confidence interval around the mean. The study size population was subsequently expanded to n = 40 to allow for assessment of outcomes in a more heterogenous population, including specifically adults aged 60 years or older (n = 10) and participants with type 2 diabetes (n = 10).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
9/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 24501 0
New Zealand
State/province [1] 24501 0

Funding & Sponsors
Funding source category [1] 310559 0
Commercial sector/Industry
Name [1] 310559 0
DexCom, Inc.
Country [1] 310559 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 311748 0
None
Name [1] 311748 0
Address [1] 311748 0
Country [1] 311748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310167 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 310167 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 310167 0
New Zealand
Date submitted for ethics approval [1] 310167 0
10/12/2021
Approval date [1] 310167 0
28/01/2022
Ethics approval number [1] 310167 0
2021 FULL 11513

Summary
Brief summary
Less than one third of people with type 1 diabetes (T1D) achieve glycaemic targets known to reduce the risk of long-term complications. Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is a new therapy that improves outcomes for people with diabetes. This study investigates a new AID system that does not require people to announce meals with an estimation of the carbohydrate content before they eat. The system has been tested using computer simulations on thousands of “virtual” people with diabetes and has shown to be safe, however, this is the first time it will be used in people.

Additionally, some people with type 2 diabetes require insulin as a component of therapy and would therefore potentially benefit from AID, however existing trials of AID in type 2 diabetes are very limited.

The study will include 40 adults with diabetes (both type 1 and type 2). The duration of the study is approximately 14 weeks. During the first two weeks of the study subjects will continue with their usual diabetes treatment and in addition will wear a blinded continuous glucose monitor. For the remaining 12 weeks of the study they will use the new automated delivery system. The system consists of an insulin pump, a continuous glucose monitor (CGM), which is worn as a small sensor in subject’s skin, and a maths program (Dexcom next generation algorithm) installed in an app on an Android phone. At set times during the 12 weeks automatic updates will occur to the maths programme in order to optimise the subjects’ average glucose levels. Subjects will be able to view their glucose readings and research staff will regularly monitor subjects’ glucose readings and pump information for safety throughout the study.

In addition to CGM and pump data, clinical, diabetic, demographic and psychosocial information will also be collected. There is also a qualitative component of the research where a sub-group of subjects will be invited to take part in an interview at the start and end of the study to gain an understanding of the factors important to quality of life for subjects; the impact of living with diabetes on those important factors; and the impact of the novel intervention on both diabetes and broader quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116726 0
Dr Martin de Bock
Address 116726 0
University of Otago
Terrace House, 4 Oxford Terrace
Christchurch 8011
Country 116726 0
New Zealand
Phone 116726 0
+64 3 3726763
Fax 116726 0
Email 116726 0
martin.debock@otago.ac.nz
Contact person for public queries
Name 116727 0
Dr Martin de Bock
Address 116727 0
University of Otago
Terrace House, 4 Oxford Terrace
Christchurch 8011
Country 116727 0
New Zealand
Phone 116727 0
+64 3 3726763
Fax 116727 0
Email 116727 0
martin.debock@otago.ac.nz
Contact person for scientific queries
Name 116728 0
Dr Martin de Bock
Address 116728 0
University of Otago
Terrace House, 4 Oxford Terrace
Christchurch 8011
Country 116728 0
New Zealand
Phone 116728 0
+64 3 3726763
Fax 116728 0
Email 116728 0
martin.debock@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
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.