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Trial registered on ANZCTR


Registration number
ACTRN12612000449831
Ethics application status
Approved
Date submitted
19/04/2012
Date registered
20/04/2012
Date last updated
7/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of changes to insulin pump basal rates in type 1 diabetes
Scientific title
Time to reach steady state insulin levels following a clinically-relevant increment and reduction in subcutaneous basal insulin infusion rates administered via an insulin pump in adults with type 1 diabetes
Secondary ID [1] 279957 0
Nil
Universal Trial Number (UTN)
U1111-1128-2409
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 285873 0
Condition category
Condition code
Metabolic and Endocrine 286059 286059 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insulin pump therapy with aspart insulin. Insulin pumps are small computerised devices delivering subcutaneous rapid-acting insulin continuously, accurately and flexibly.

Intervention - following a stable baseline subcutaneous insulin infusion rate for 6 hours, a clinically-relevant change is to be made to the basal insulin infusion rate. For the next 5 hours, circulating insulin levels are to be tested 15-minutely to assess the time to reach steady state circulating insulin levels. At the first study visit, the basal insulin rate change is to be an increment, and at the second study visit (1-6 weeks after the first visit) the rate change is to be a reduction. The total dose of subcutaneous insulin infused during the 5-hour intervention period will be between 2 units and 10 units (depending on the insulin requirements of the individual). Standardised insulin pumps and aspart insulin will be used for each study visit, and participants will resume their usual insulin and insulin pump at the conclusion of each visit.
Intervention code [1] 284289 0
Treatment: Devices
Intervention code [2] 284686 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286540 0
Time to reach steady state circulating insulin levels following a change in basal insulin infusion rate. Insulin levels will be measured using plasma from venous blood for free insulin radioimmunoassay (plasma with insulin antibodies will be pre-treated with polyethylene glycol to precipitate bound insulin).
Timepoint [1] 286540 0
Insulin levels assessed for 5 hours after basal insulin infusion rate change (insulin levels tested 15-minutely over this period)
Secondary outcome [1] 296120 0
Time to reach 90% steady state circulating insulin levels following a change in basal insulin infusion rate. Insulin levels will be measured using plasma from venous blood for free insulin radioimmunoassay (plasma with insulin antibodies will be pre-treated with polyethylene glycol to precipitate bound insulin).
Timepoint [1] 296120 0
Insulin levels assessed for 5 hours after basal insulin infusion rate change (insulin levels tested 15-minutely over this period)
Secondary outcome [2] 296121 0
The impact of the baseline insulin infusion rate on time to reach steady state circulating insulin levels following a change in basal insulin infusion rate. Insulin levels will be measured using plasma from venous blood for free insulin radioimmunoassay (plasma with insulin antibodies will be pre-treated with polyethylene glycol to precipitate bound insulin).
Timepoint [2] 296121 0
Insulin levels assessed for 5 hours after basal insulin infusion rate change (insulin levels tested 15-minutely over this period)
Secondary outcome [3] 296122 0
The impact of percentage increment in insulin infusion rate on time to reach steady state circulating insulin levels following a change in basal insulin infusion rate. Insulin levels will be measured using plasma from venous blood for free insulin radioimmunoassay (plasma with insulin antibodies will be pre-treated with polyethylene glycol to precipitate bound insulin).
Timepoint [3] 296122 0
Insulin levels assessed for 5 hours after basal insulin infusion rate change (insulin levels tested 15-minutely over this period)
Secondary outcome [4] 297174 0
Time to reach steady state blood glucose levels following a change in basal insulin infusion rate. Glucose concentrations will be measured via the glucose oxidase method using plasma from venous blood.
Timepoint [4] 297174 0
Venous glucose levels assessed for 5 hours after basal insulin infusion rate change (venous glucose levels tested 15-minutely over this period)
Secondary outcome [5] 297175 0
Time to reach steady state interstitial glucose levels following a change in basal insulin infusion rate. Interstitial glucose will be measured using a continuous glucose monitoring device with a small sensor inserted under the skin for the duration of the intervention.
Timepoint [5] 297175 0
Interstitial glucose levels assessed continuously for 5 hours after basal insulin infusion rate change

Eligibility
Key inclusion criteria
Clinical diagnosis of type 1 diabetes, managed with insulin pump therapy for minimum of 3 months, established insulin:carbohydrate ratio, established insulin sensitivity, established basal insulin delivery profile including a rate of 0.60-1.40 units per hour overnight (without significant variation during this period).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or planned pregnancy, episode of diabetic ketoacidosis or major hypoglycaemia (requiring third party assistance) within the last 3 months, significant renal impairment (estimated glomerular filtration rate <40 mL per min), unresolved adverse skin condition in the area of cannula or device placement, body mass index >30 or <18, allergy to insulin aspart.

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
Phase 4
Type of endpoint(s)
Pharmacokinetics
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)
VIC
Recruitment hospital [1] 311 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 5242 0
3065

Funding & Sponsors
Funding source category [1] 285102 0
Hospital
Name [1] 285102 0
St Vincent's Hospital, Melbourne
Address [1] 285102 0
41 Victoria Parade
Fitzroy VIC 3065
Country [1] 285102 0
Australia
Funding source category [2] 285103 0
Government body
Name [2] 285103 0
National Health and Medical Research Council
Address [2] 285103 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 285103 0
Australia
Funding source category [3] 285107 0
Charities/Societies/Foundations
Name [3] 285107 0
Royal Australian College of Physicians Research and Education Foundation
Address [3] 285107 0
145 Macquarie Street
Sydney NSW 2000
Country [3] 285107 0
Australia
Funding source category [4] 285108 0
Commercial sector/Industry
Name [4] 285108 0
Roche Diagnostics
Address [4] 285108 0
81-89 Cotham Road
Kew VIC 3101
Country [4] 285108 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Melbourne
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 283997 0
University
Name [1] 283997 0
The University of Melbourne, Department of Medicine, St Vincent's
Address [1] 283997 0
29 Regent Street
Fitzroy VIC 3065
Country [1] 283997 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286733 0
St Vincent's Hospital, Melbourne
Ethics committee address [1] 286733 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 286733 0
Australia
Date submitted for ethics approval [1] 286733 0
23/01/2012
Approval date [1] 286733 0
27/03/2012
Ethics approval number [1] 286733 0
#013/12

Summary
Brief summary
Insulin pumps are increasingly being used to deliver insulin for people with type 1 diabetes. The two main components of insulin pump delivery are firstly "bolus" insulin, used with meals or to correct high glucose levels, and secondly "basal" insulin which provides the background insulin requirements of the individual. The rate of basal insulin delivered can be adjusted with the pump, and this may vary according to the time of day, stress, illness or exercise.

Information regarding changes in the basal insulin infusion rate to best match an individual's insulin requirement is essential to guide clinical decision-making. The purpose of this study is to determine the time to reach steady state circulating insulin levels after a clinically-relevant increase and also a clinically-relevant reduction in basal insulin infusion rates delivered by insulin pumps to adults with type 1 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30834 0
A/Prof David O'Neal
Address 30834 0
Department of Endocrinology, St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy 3065 VIC
Country 30834 0
Australia
Phone 30834 0
+61 3 92882574
Fax 30834 0
Email 30834 0
dno@unimelb.edu.au
Contact person for public queries
Name 14081 0
Dr Dr Sybil McAuley
Address 14081 0
Department of Endocrinology
St Vincent's Hospital, Melbourne
35 Victoria Parade
Fitzroy VIC 3065
Country 14081 0
Australia
Phone 14081 0
+61 3 92882211
Fax 14081 0
Email 14081 0
sybil.mcauley@svhm.org.au
Contact person for scientific queries
Name 5009 0
Dr Dr Sybil McAuley
Address 5009 0
Department of Endocrinology
St Vincent's Hospital, Melbourne
35 Victoria Parade
Fitzroy VIC 3065
Country 5009 0
Australia
Phone 5009 0
+61 3 92882211
Fax 5009 0
Email 5009 0
sybil.mcauley@svhm.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary