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Trial registered on ANZCTR


Registration number
ACTRN12610000024044
Ethics application status
Approved
Date submitted
27/11/2009
Date registered
8/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Low Glucose Suspend Trial - Comparing insulin pump therapy with low glucose suspend feature versus standard insulin pump therapy in patients with type 1 diabetes with hypoglycaemia unawareness
Scientific title
The use of continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and low glucose suspend feature (CSII + RT-CGMS + LGS) versus continuous subcutaneous insulin infusion only (CSII) in patients with type 1 diabetes (T1D) with impaired awareness of hypoglycaemia - a randomised controlled trial
Secondary ID [1] 1255 0
None
Universal Trial Number (UTN)
Trial acronym
LGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes
Hypoglycaemia unawareness 252305 0
Condition category
Condition code
Metabolic and Endocrine 252485 252485 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 low glucose suspend feature (Paradigm Veo)for six months duration. Dose of insulin will remain unchanged as per clinician prescribed regimen. Continuous glucose monitoring will involve insertion of a sensor just under the skin that sends continuous blood glucose readings back to the Paradigm Veo pump. This pump has the added feature of Low Glucose Suspend function. If a low glucose level is detected 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] 241618 0
Treatment: Devices
Comparator / control treatment
Standard pump therapy - continuous subcutaneous insulin infusion only for the duration of six months. Dose of insulin will remain unchanged as per clinician prescribed regimen.
Control group
Active

Outcomes
Primary outcome [1] 253368 0
The primary outcome is the rate of severe and moderate hypoglycaemia. Severe hypoglycaemia is defined a hypoglycaemic event associated with loss of consciousness or seizure. Moderate hypoglycaemia is defined as a hypoglycaemic event requiring assistance. In addition to patient recall, moderate hypoglycaemia will be further quantified with the use of blinded CGMS before, during and after the intervention period. Moderate hypoglycaemia will be described as episodes of blood glucose level <2.8mmol/L.
Timepoint [1] 253368 0
Baseline, after 6 months on pump and after 6 months off pump
Secondary outcome [1] 262444 0
Hypoglycaemia awareness score
Timepoint [1] 262444 0
Baseline, after 6 months on pump and after 6 months off pump
Secondary outcome [2] 262445 0
Duration of nocturnal hypoglycaemia
Timepoint [2] 262445 0
Baseline, after 6 months on pump and after 6 months off pump
Secondary outcome [3] 262446 0
Change in glycaemic control measured by glycated haemaglobin (HbA1C)
Timepoint [3] 262446 0
Baseline, after 6 months on pump and after 6 months off pump
Secondary outcome [4] 262447 0
In a subset of adolescent patients, counterregulatory hormone response to hypoglycaemia, as measured during hyperinsulinaemic hypoglycaemic clamp study. This involves recreating hypoglycaemia through a controlled infusion of insulin and glucose. Participants will need to spend a day in hospital around visit 3 and 5, before and after the 6 month intervention. During this procedure, patients have two intravenous drips inserted into the veins in each arm, one for infusion of insulin and glucose and one for blood samples to be taken. Blood glucose levels are monitored closely and dropped from normal range to a low level over several hours. This level is low enough to cause the body to respond and drive the glucose level in the body up but not low enough to cause seizures or coma.
Timepoint [4] 262447 0
Before and after the 6 month intervention
Secondary outcome [5] 262448 0
During the hypoglycaemic clamp study as described previoiusly, we also ask about symptoms experienced during hypoglycaemia (such as shakiness, hunger) to obtain an adrenergic symptoms score
Timepoint [5] 262448 0
Before and after the 6 month intervention
Secondary outcome [6] 262449 0
Patient-reported outcomes - EQ-5D, Hypoglycaemia Fear Survey and Pump Satisfaction Questionnaire
Timepoint [6] 262449 0
Baseline, after 6 months on pump and 6 months off pump

Eligibility
Key inclusion criteria
Duration of diabetes greater than or equal 12 months
On insulin pump therapy greater than or equal to 6 months
Glycated haemaglobin (HbA1C) between 6 and 8.5%
Impaired awareness of hypoglycaemia
Minimum age
4 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has adrenal insufficiency
Has growth hormone insufficiency
Has multiple pituitary hormone deficiency
Is pregnant

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)
Recruitment of participants will be performed by study co-ordinator 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)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256099 0
Hospital
Name [1] 256099 0
Princess Margaret Hospital for Children
Country [1] 256099 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Level 3, Roberts Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 251445 0
None
Name [1] 251445 0
Address [1] 251445 0
Country [1] 251445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258186 0
Princess Margaret Hospital for Children
Ethics committee address [1] 258186 0
Children's Clinical Research Facility
Roberts Road
Subiaco WA 6008
Ethics committee country [1] 258186 0
Australia
Date submitted for ethics approval [1] 258186 0
Approval date [1] 258186 0
15/10/2009
Ethics approval number [1] 258186 0
1697/EP

Summary
Brief summary
This study will compare the new insulin pump with low glucose suspend feature with current pump therapy to see if there is any change in rates of hypoglycaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30559 0
Address 30559 0
Country 30559 0
Phone 30559 0
Fax 30559 0
Email 30559 0
Contact person for public queries
Name 13806 0
Dr. Trang Ly
Address 13806 0
Department of Endocrinology and Diabetes
Princess Margaret Hospital for Children
Roberts Road
Subiaco WA 6008
Country 13806 0
Australia
Phone 13806 0
+61 403 136 117 / +61 8 9340 8090
Fax 13806 0
Email 13806 0
[email protected]
Contact person for scientific queries
Name 4734 0
Dr. Trang Ly
Address 4734 0
Department of Endocrinology and Diabetes
Princess Margaret Hospital for Children
Roberts Road
Subiaco WA 6008
Country 4734 0
Australia
Phone 4734 0
+61 403 136 117 / +61 8 9340 8090
Fax 4734 0
Email 4734 0
[email protected]

No information has been provided regarding IPD availability


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.