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Trial registered on ANZCTR


Registration number
ACTRN12614000510640
Ethics application status
Approved
Date submitted
6/05/2014
Date registered
13/05/2014
Date last updated
6/12/2019
Date data sharing statement initially provided
6/12/2019
Date results information initially provided
6/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictive Low Glucose Management (PLGM) Trial : Comparing insulin pump therapy with predictive low glucose suspend feature versus standard sensor augmented pump therapy in patients with type 1 diabetes.
Scientific title
The prediction and prevention of hypoglycaemia using insulin suspension in a randomised controlled trial with the use of continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and predictive low glucose suspend feature (CSII + RT-CGMS + PLGM) versus sensor augmented pump therapy with continuous subcutaneous insulin infusion only (CSII+ RT-CGMS) in children and adolescents with type 1 diabetes (T1D)
Secondary ID [1] 284551 0
NIL
Universal Trial Number (UTN)
Trial acronym
PLGM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 291815 0
Condition category
Condition code
Metabolic and Endocrine 292178 292178 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and predictive low glucose suspend feature (Medtronic Minimed 640G) for six months duration. Continuous glucose monitoring will involve insertion of a sensor just under the skin that sends continuous glucose readings back to the insulin pump. This pump has the added feature of Predictive Low Glucose Suspend function. If a low glucose level is predicted to be reached in 30 minutes and the patient does not respond to the alarm, the pump will suspend insulin infusion for 2 hours. Both the pump and glucose sensor system will be worn for the entire 6 months.
Intervention code [1] 289312 0
Treatment: Devices
Comparator / control treatment
Standard sensor augmented pump therapy - continuous subcutaneous insulin infusion with real-time continuous glucose monitoring for the duration of six months. The predictive function will be off on the pump.
Control group
Active

Outcomes
Primary outcome [1] 292056 0
To compare the average % time spent hypoglycaemic (sensor glucose level <3.5 mmol/l) during 6 months of therapy with the CSII + RT-CGMS + predictive low glucose insulin suspend and resume vs. CSII + RT-CGMS alone.
Timepoint [1] 292056 0
End of 6 months
Secondary outcome [1] 308094 0
To compare the events of hypoglycaemia, defined as 20 minutes or more with sensor glucose < 3.5mmol/l, during 6 months of therapy with the CSII + RT-CGMS + predictive low glucose insulin suspend and resume vs. CSII + RT-CGMS alone
Timepoint [1] 308094 0
End of 6 months
Secondary outcome [2] 308095 0
To compare the sensor glucose profile during 6 months of therapy with CSII + RT-CGMS + predictive low glucose insulin suspend and resume vs. CSII + RT-CGMS alone.
Timepoint [2] 308095 0
End of 6 months
Secondary outcome [3] 308096 0
To determine the counterregulatory hormone response and adrenergic responses to hypoglycaemia, as measured during hyperinsulinaemic hypoglycaemic clamp study in participants with hypoglycaemia unawareness
Timepoint [3] 308096 0
Baseline and end of 6 months
Secondary outcome [4] 308097 0
To determine patient satisfaction and acceptability assessed by a Pump Satisfaction Questionnaire and to measure the impact of the intervention on patient’s quality of life and fear of hypoglycaemia as assessed by Quality of Life Questionnaire (EQ-5Dy), the Fear of Hypoglycaemia and Hypoglycaemia Awareness questionaire
Timepoint [4] 308097 0
At the beginning, 3 months and 6 months of the study.

Eligibility
Key inclusion criteria
1) Age: 8-20yrs at Princess Margaret Hospital, Perth and John Hunter Children's Hospital, Newcastle; Age 8-18yrs at Westmead Children's Hospital, Sydney, Women and Children's Hospital,Adelaide and RCH, Melbourne
2) T1DM for >1 year
3) On insulin pump therapy for >6 months
4) HbA1c < 10.0%
Minimum age
8 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Medical conditions predisposing to hypoglycaemia other than diabetes
2) Oral glycaemic medications
3) Inability or refusal to meet protocol requirements
4 ) Pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment of participants will be performed by study co-ordinator at each site who is unaware at the time of recruitment, which group the participant will be allocated. Allocation of treatment is concealed and performed by computerised central randomisaion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using a computer software which is adapted to minimisation of variation in gender, age, diabetes duration, HbA1c, fear of hypoglycaemia score and centre site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 2416 0
Princess Margaret Hospital for Children, Perth
Recruitment hospital [2] 2417 0
The Children’s Hospital at Westmead, Sydney
Recruitment hospital [3] 2418 0
John Hunter Children’s Hospital, Newcastle
Recruitment hospital [4] 2419 0
Royal Children’s Hospital, Melbourne
Recruitment hospital [5] 2443 0
Womens and Childrens Hospital - North Adelaide

Funding & Sponsors
Funding source category [1] 289177 0
Charities/Societies/Foundations
Name [1] 289177 0
Juvenile Diabetes Research Foundation
Address [1] 289177 0
PO Box 183, St Leonards NSW 1590
Country [1] 289177 0
Australia
Primary sponsor type
Individual
Name
Professor Timothy Jones
Address
Princess Margaret Hospital
Level 3, Roberts Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 287846 0
Individual
Name [1] 287846 0
Dr Jan Fairchild
Address [1] 287846 0
Endocrinology and Diabetes Centre,
Women’s and Children’s Hospital,
72 King William Road,
North Adelaide, SA 5006
Country [1] 287846 0
Australia
Secondary sponsor category [2] 287875 0
Individual
Name [2] 287875 0
Professor Fergus Cameron
Address [2] 287875 0
Department of Endocrinology and Diabetes,
Royal Children’s Hospital,
Flemington Road,
Parkville, VIC 3052
Country [2] 287875 0
Australia
Secondary sponsor category [3] 287876 0
Individual
Name [3] 287876 0
A/Professor Bruce King
Address [3] 287876 0
Department of endocrinology and diabetes,
John Hunter Children's Hospital,
Lookout Road,
Newcastle, NSW 2310
Country [3] 287876 0
Australia
Secondary sponsor category [4] 287877 0
Individual
Name [4] 287877 0
Professor Geoff Ambler
Address [4] 287877 0
Institute of Endocrinology and Diabetes,
The Children’s Hospital at Westmead,
Locked Bag 4001, Westmead,
Sydney NSW 2145
Country [4] 287877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290953 0
Princess Margaret Hospital for Children
Ethics committee address [1] 290953 0
Children's Clinical Research Facility
Roberts Road
Subiaco WA 6008
Ethics committee country [1] 290953 0
Australia
Date submitted for ethics approval [1] 290953 0
Approval date [1] 290953 0
02/05/2014
Ethics approval number [1] 290953 0
2013121EP
Ethics committee name [2] 290954 0
John Hunter Children's Hospital
Ethics committee address [2] 290954 0
Department of endocrinology and diabetes,
Lookout Road,
Newcastle, NSW 2310
Ethics committee country [2] 290954 0
Australia
Date submitted for ethics approval [2] 290954 0
Approval date [2] 290954 0
07/04/2014
Ethics approval number [2] 290954 0
13/12/11/3.07
Ethics committee name [3] 290955 0
Women’s and Children’s Hospital, Adelaide
Ethics committee address [3] 290955 0
Endocrinology and Diabetes Centre,
72 King William Road,
North Adelaide, SA 5006
Ethics committee country [3] 290955 0
Date submitted for ethics approval [3] 290955 0
12/03/2014
Approval date [3] 290955 0
Ethics approval number [3] 290955 0
Ethics committee name [4] 290956 0
The Children’s Hospital at Westmead
Ethics committee address [4] 290956 0
Institute of Endocrinology and Diabetes,
The Children’s Hospital at Westmead,
Locked Bag 4001, Westmead,
Sydney NSW 2145
Ethics committee country [4] 290956 0
Australia
Date submitted for ethics approval [4] 290956 0
Approval date [4] 290956 0
Ethics approval number [4] 290956 0
Ethics committee name [5] 290957 0
Royal Children’s Hospital, Melbourne
Ethics committee address [5] 290957 0
Department of Endocrinology and Diabetes,
Royal Children’s Hospital,
Flemington Road,
Parkville, VIC 3052
Ethics committee country [5] 290957 0
Australia
Date submitted for ethics approval [5] 290957 0
20/05/2014
Approval date [5] 290957 0
Ethics approval number [5] 290957 0

Summary
Brief summary
This study will compare the new insulin pump with predictive low glucose suspend feature with current pump therapy with the aim to reduce the time spent hypoglycaemic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48142 0
Prof Timothy Jones
Address 48142 0
Department of Endocrinology and Diabetes,
Princess Margaret Hospital for Children,
Roberts Road,
Subiaco WA 6008
Country 48142 0
Australia
Phone 48142 0
+61 8 9340 8090
Fax 48142 0
Email 48142 0
Tim.Jones@health.wa.gov.au
Contact person for public queries
Name 48143 0
Ms Jennifer Nicholas
Address 48143 0
Princess Margaret Hospital for Children,
Roberts Road,
Subiaco WA 6008
Country 48143 0
Australia
Phone 48143 0
+61 8 9340 7861
Fax 48143 0
Email 48143 0
Jennifer.Nicholas2@health.wa.gov.au
Contact person for scientific queries
Name 48144 0
Dr Mary Abraham
Address 48144 0
Department of Endocrinology and Diabetes,
Princess Margaret Hospital for Children,
Roberts Road,
Subiaco WA 6008
Country 48144 0
Australia
Phone 48144 0
+61 8 9340 8090
Fax 48144 0
Email 48144 0
Mary.Abraham@health.wa.gov.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6059 0
Abraham MB, Nicholas JA, Smith GJ, Fairchild JM, King BR, Ambler GR, et al. Reduction in Hypoglycemia with the Predictive Low-Glucose Management System: A Long-term Randomized Controlled Trial in Adolescents with Type 1 Diabetes. Diabetes care. 2018; 41(2):303-10.
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary