Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000648820
Ethics application status
Approved
Date submitted
19/04/2021
Date registered
31/05/2021
Date last updated
23/05/2022
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Wearing your Continuous Glucose Monitor on your Sleeve : A Trial in Adults with Type 1 Diabetes
Scientific title
A Randomised Cross Over Trial Investigating the Impact of Smart Watch Integrated Do-it-yourself (DIY) Continuous Glucose Monitoring on Glycaemic Control in Adults with Type 1 Diabetes
Secondary ID [1] 303973 0
nil known
Universal Trial Number (UTN)
U111-1262-2784.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 321588 0
Glycaemic control 321607 0
Condition category
Condition code
Metabolic and Endocrine 319329 319329 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multicentre randomized controlled crossover trial investigating the impact of do-it-yourself continuous glucose monitoring (DIY-CGM) compared to Flash Glucose Monitoring(FGM) alone on optimizing glycaemic control.
DIY-CGM uses near field communication to detect the signal/raw data generated by FGM and broadcasts it to a Bluetooth enabled device such as a watch or phone. Our study will utilise a study phone (android) to broadcast DIY-CGM glucose levels to a fit bit versa 2 smart watch. Both devices will be provided by the study team.
Participants will be educated using a mixture of online and printed sponsor(University of Otago) derived instruction manuals and troubleshooting guides.
The intervention(s) will be administered by an adult Endocrinologist(independent of the clinic treating team) together with two research nurses.
The trial will be a randomized crossover trial with two 8 week intervention periods and a 4-week washout.
The primary outcome is time in range from baseline compared to end of study(week 21).
Expected duration of subject participation is 21 weeks .
Intervention code [1] 320281 0
Treatment: Devices
Intervention code [2] 320300 0
Lifestyle
Comparator / control treatment
Flash-Glucose Monitoring in the form of an Abbot Free Style Libre Flash Glucose Monitor.
Control group
Active

Outcomes
Primary outcome [1] 327196 0
Time in Range - Percentage of time that Interstitial Glucose Levels between 3.9-10mmol/L.using both a flash glucose monitor and a do-it yourself continuous glucose monitor(DIY-CGM) linked to participants personal mobile phone.
The research team will access the results as they are uploaded to Tidepool- a secure , password-protected cloud-based server.
Timepoint [1] 327196 0
Baseline- Week1
Every 2 weeks between the two endpoints( weeks 3,5,7,9,11,13,15,17 ,19)
Endpoint- Week 21.
Secondary outcome [1] 394149 0
Continuous Glucose Monitoring - Percentage of time that interstitial glucose levels are above 10mmol./L.through an audit of patient's cloud-based glucose data on Tidepool..
Timepoint [1] 394149 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [2] 394150 0
Continuous Glucose Monitoring - Percentage of time that interstitial glucose levels are >13.9mmol through an audit of patient's cloud-based glucose data on Tidepool..
Timepoint [2] 394150 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [3] 394151 0
Continuous Glucose Monitoring - Percentage of time that interstitial glucose levels are <3.9mmol through an audit of patient's cloud-based glucose data on Tidepool..
Timepoint [3] 394151 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [4] 394152 0
Continuous Glucose Monitoring - Time spent in severe hypoglycaemia (glucose < 3.0 mmol/L) through an audit of patient's cloud-based glucose data on Tidepool..
Timepoint [4] 394152 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [5] 394154 0
Fear of hypoglycemia- As measured by the Hypoglycemia Fear Survey Behavior(B) and Worry (W)subscales
Timepoint [5] 394154 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [6] 394155 0
Diabetes-related distress in patients measured by the Problem Areas in Diabetes (PAID-20) scale
Timepoint [6] 394155 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [7] 394156 0
Diabetes-related quality of life - evaluated by Dawn 2 impact of Diabetes Profile (DIDP) questionnaire.
Timepoint [7] 394156 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [8] 394157 0
Partner distress will be evaluated by The Diabetes Distress Scale-Partner (DDS-P) questionnaire
Timepoint [8] 394157 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [9] 394158 0
User- Acceptability of Glucose Management technology(FGM and CGM)- Glucose Management Satisfaction Survey (GMSS) questionnaire
Timepoint [9] 394158 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [10] 394159 0
Awareness of hypoglycemia- Measured by the GOLD score questionnaire
Timepoint [10] 394159 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [11] 394160 0
Sleep Timing, quantity, and quality a measured by the Pittsburgh Sleep Quality index (PSQI)
Timepoint [11] 394160 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [12] 394243 0
Glycaemic control as measured by glycated hemoglobin (Hba1c)
Timepoint [12] 394243 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [13] 394244 0
Diabetes Treatment Satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire -Status(S) and change(C) Verisons
Timepoint [13] 394244 0
Baseline- Week1 -Status version
Midpoint 1- Week 9-Change Version
Midpoint 2-Week 13-Change Version
Endpoint- Week 21.-Status Version
Secondary outcome [14] 394245 0
Number of Days of School/University/Work missed per month on electronically administered study specific Questionnaire
Timepoint [14] 394245 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [15] 394246 0
Hospitalization episodes for Diabetic Ketoacidosis -through audit of patient's electronic medical data.
Timepoint [15] 394246 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [16] 394247 0
Continuous Glucose Monitoring- Percentage of time that either DIY-CGM or FGM sensor is used through an audit of patient's cloud-based glucose data.
Timepoint [16] 394247 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [17] 394248 0
If the following function is being used by participant's spouse on DIY-CGM- response to be evaluated by questionnaire as binary(yes/no)
Timepoint [17] 394248 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.
Secondary outcome [18] 394249 0
intervention adherence as assessed by the percentage of time sensor use is captured by cloud-based tool Tidepool)
Timepoint [18] 394249 0
Baseline- Week1
Midpoint 1- Week 9
Midpoint 2-Week 13
Endpoint- Week 21.

Eligibility
Key inclusion criteria
1) Aged greater than or equal to 16 years
2) Already using FGM (Abbot Free Style Libre) technology with no restrictions based on insulin regimen;
3) Diagnosed with T1 Diabetes for at least 6 months;
4) At least 0.5 units of insulin/kg/day;
5) Plans to continue with routine clinical care during the whole period of the study;
6) Intention for continuous use of FGM during the whole study period (17-week)
7) Currently residing in and expecting to remain in regions served by the Capital and Coast District Health Board (DHB), Canterbury DHB. Waikato, Mid-central DHB, Hawkes Bay, and Southern District Health Boards for the next 21 weeks.
8) Ability to understand study procedures, including English language proficiency, and to comply with them for the entire length of the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Already using DIY-CGMS or another CGM product (other than FGM)
2) Any severe diabetes related complications (nephropathy requiring renal replacement therapy, retinopathy with associated visual loss – milder degrees will not be excluded);
3) Other severe uncontrolled medical or psychiatric co-morbidity/severe mental illness.
4) Participation in another device or drug study that could affect glucose measurements during the study period;
5) Inability of the patient to give written informed consent.
6) Plan to leave study regions prior to study completion.
7) Pregnant or planning to become pregnant during the study.
8) Using oral steroid medication (prednisone or another steroid) for two weeks or more prior to starting the study.
9) Taking tablets or injections for type 2 diabetes such as GLP-1 and SGLT-2 inhibitors.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized Sequence Generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study has a primary endpoint comparing Time in Range (TIR) and average sensor glucose from baseline CGM data to the final two weeks of the intervention(weeks 19-21). Data will be presented as mean changes and standard deviations.
The primary analysis will follow the intent-to-treat principle with all participants analysed in the group to which they were randomised, regardless of actual DIY-CGM/FGM wear (with departures from pure intent-to-treat due to missing data due to sensor failure/lack of data capture at particular assessment times). The results will be analysed using linear mixed models for continuous outcomes (including the primary outcome of time in range) with a random participant-phase effect to incorporate the multiple measurements taken for study participants within each 8-week phase (once at the start and once at the end of that phase) and a random participant effect for the multiple measurements from each participant both using the DIY-CGM and then without this device. The centres will be modelled using a random effect, although we do not anticipate this having any effect on results.
The statistical models will include period effects to accommodate systematic changes during the study. Tests for washout will be performed. Standard model diagnostics will be used and log-transformations considered if model residuals are skewed, and mixed quantile regression (modelling medians) if this does not resolve issues with residuals. The number of adverse events is likely to be low and will be compared between conditions using signed Wilcoxon tests, which will ignore any clustering effects within centres. Two-sided p<0.05 will be considered statistically significant. Missing data is unlikely to be substantial given our previous research but we have allowed for just under 10% loss to attrition in designing the study.
Additional sleep statistical analyses will be performed using linear mixed models as above to model sleep parameters, and related outcomes. The potential mediating effects of change in QOL, and fear of hypoglycaemia on sleep outcomes will be investigated as well as the potential mediating effects of change in sleep, QOL, and fear of hypoglycaemia outcomes.
Should higher levels of missing data eventuate, pattern mixture models will be used to explore the robustness of study findings under plausible scenarios of informative missing data. Statistical analysis will be performed using R 3.6.0 with two-sided p < 0.05 considered significant

MISSING DATA
All ITT analyses will incorporate all available data, the full analysis set, and there will be on imputation of missing data. For the general linear mixed models participants are not required to have both interventions to be included in the analyses.
DEVIATION FROM PLANNED STATISTICAL ANALYSIS
Any deviation from the planned statistical analysis will be described in the final study report.
ANALYSIS POPULATIONS
SAFETY ANALYSIS POPULATION
All subjects who have used the study device, whether prematurely withdrawn from the study or not, will be included in the safety analysis population.
INTENT-TO-TREAT POPULATION
All subjects who complete the screening process and are enrolled into the study (i.e. assigned to a treatment sequence) are included in the Intent-to-Treat (ITT) population. This population is the primary analysis population for all non-safety related analyses.
PER-PROTOCOL POPULATION
Subset of the ITT population who meet all inclusion and exclusion criteria and have complete CGM data will be included in the Per-Protocol (PP) population. All decisions on subject exclusions from the PP population will be made prior to database closure and will be justified in the clinical study report.
SAFETY DATA ANALYSIS
All safety analyses will be based on the safety analysis population.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2021
Date of last participant enrolment
Anticipated
16/06/2022
Actual
Date of last data collection
Anticipated
16/11/2022
Actual
Sample size
Target
60
Accrual to date
54
Final
Recruitment outside Australia
Country [1] 23602 0
New Zealand
State/province [1] 23602 0
Otago, Southland, HawkesBay, Wellington, Waikato.,Canterbury

Funding & Sponsors
Funding source category [1] 308353 0
Government body
Name [1] 308353 0
Health Research Council (New Zealand)
Country [1] 308353 0
New Zealand
Funding source category [2] 308355 0
University
Name [2] 308355 0
University of Otago Dunedin School of Medicine
Country [2] 308355 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Centre for Innovation Level 1
87 St David Street
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309175 0
None
Name [1] 309175 0
Address [1] 309175 0
Country [1] 309175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308325 0
Central Health and disability ethics committee
Ethics committee address [1] 308325 0
Ethics committee country [1] 308325 0
New Zealand
Date submitted for ethics approval [1] 308325 0
26/02/2021
Approval date [1] 308325 0
30/04/2021
Ethics approval number [1] 308325 0
21/CEN/74

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

Contacts
Principal investigator
Name 110310 0
A/Prof Ben Wheeler
Address 110310 0
Department of Woman's and Children's Health
University of Otago
201 Great King Street
Dunedin 9054
Dunedin
New Zealand
Country 110310 0
New Zealand
Phone 110310 0
+64 27 470 1980
Fax 110310 0
Email 110310 0
[email protected]
Contact person for public queries
Name 110311 0
Ben Wheeler
Address 110311 0
Department of Woman's and Children's Health
University of Otago
201 Great King Street
Dunedin 9054
Dunedin
New Zealand
Country 110311 0
New Zealand
Phone 110311 0
+64 27 470 1980
Fax 110311 0
Email 110311 0
[email protected]
Contact person for scientific queries
Name 110312 0
Ben Wheeler
Address 110312 0
Department of Woman's and Children's Health
University of Otago
201 Great King Street
Dunedin 9054
Dunedin
New Zealand
Country 110312 0
New Zealand
Phone 110312 0
+64 27 470 1980
Fax 110312 0
Email 110312 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
IPD is not available.


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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: Safety and efficacy of smart watch integrated do-it-yourself continuous glucose monitoring in adults with Type 1 diabetes, a randomised controlled trial.2021https://dx.doi.org/10.1007/s40200-021-00923-y
N.B. These documents automatically identified may not have been verified by the study sponsor.