Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000171314
Ethics application status
Approved
Date submitted
28/11/2016
Date registered
1/02/2017
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Long term benefits of insulin pump use in people with type 1 diabetes
Scientific title
Long term follow-up on the real-world efficacy of insulin pump therapy in people with type 1 diabetes: retrospective cohort study.
Secondary ID [1] 290636 0
none
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes mellitus 301158 0
Condition category
Condition code
Metabolic and Endocrine 300922 300922 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective cohort study that does not involve participant recruitment/enrollment. Data collection will be from electronic medical records of clinical data routinely collected as part of clinical care.

Clinic data obtained as part of patient follow-up will be collected from the electronic medical record of people commenced on insulin pump therapy compared to people provided with standard care which is a formalised training in insulin dose adjustment (FlexIt Program). People included are those where commencement of insulin pump therapy or the FlexIt program was between 2000 and 2011. Clinic data will be collected from the time of commencement of nsulin pump therapy or the FlexIt program to December 2016 which is the end of follow-up..

Clinical outcome data that will be extracted includes:
1. demographic information – age and gender, duration of diabetes
2. glycemic control (HbA1c)
3. diabetes renal complications (albuminuria and eGFR) and cardiovascular risk factors (SBP and DBP, lipid profile (total cholesterol, LDL, HDL, triglycerides, weight)
4. utilization of health care resources and appropriate technical and practical use of insulin pump therapy (as determined from insulin pump data uploaded to computer on clinic visits)
Intervention code [1] 296519 0
Not applicable
Comparator / control treatment
standard care in type 1 diabetes - formalised training in insulin dose adjustment
Control group
Active

Outcomes
Primary outcome [1] 300336 0
glycemic control (HbA1c)
Timepoint [1] 300336 0
Starting point: Commencement of insulin pump therapy (intervention group) or FlexIt Program (control group) for people commenced between 2000 and 2011
Endpoint: December 2016
Primary outcome [2] 300838 0
diabetes renal complications (albuminuria and eGFR)
Timepoint [2] 300838 0
Starting point: Commencement of insulin pump therapy (intervention group) or FlexIt Program (control group) for people commenced between 2000 and 2011
Endpoint: December 2016
Primary outcome [3] 300839 0
utilization of health care resources
Timepoint [3] 300839 0
Starting point: Commencement of insulin pump therapy (intervention group) or FlexIt Program (control group) for people commenced between 2000 and 2011
Endpoint: December 2016
Secondary outcome [1] 331005 0
glucose stability (based on blood glucose average, blood glucose SD, and HbA1c SD)
Timepoint [1] 331005 0
Starting point: Commencement of insulin pump therapy (intervention group) or FlexIt Program (control group) for people commenced between 2000 and 2011
Endpoint: December 2016
Secondary outcome [2] 331006 0
cardiovascular risk factors - SBP and DBP, lipid profile (total cholesterol, LDL, HDL, triglycerides), weight
Timepoint [2] 331006 0
Starting point: Commencement of insulin pump therapy (intervention group) or FlexIt Program (control group) for people commenced between 2000 and 2011
Endpoint: December 2016
Secondary outcome [3] 331007 0
appropriate technical and practical use of insulin pump therapy (as determined from insulin pump data uploaded to computer on clinic visits)
Timepoint [3] 331007 0
Starting point: Commencement of insulin pump therapy (intervention group) or FlexIt Program (control group) for people commenced between 2000 and 2011
Endpoint: December 2016

Eligibility
Key inclusion criteria
commencement of insulin pump therapy or undertaking of formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011 at the Baker Diabetes Clinical Services
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not being commencement of insulin pump therapy or not undertaking of formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011 at the Baker Diabetes Clinical Services

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Differences between the two patient groups will be by:
(i) ANOVA for continuous variables
(ii) chi2 test/Fisher exact for categorical variables.

Assessment of the impact of treatment modality and clinical factors on glycemic control, hypoglycaemia, weight changes and clinical service utilisation will be by:
(i) logistic regression analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2017
Actual
Date of last participant enrolment
Anticipated
31/05/2017
Actual
Date of last data collection
Anticipated
31/05/2017
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14733 0
3004 - St Kilda Road Melbourne

Funding & Sponsors
Funding source category [1] 295070 0
Other
Name [1] 295070 0
Baker Heart and Diabetes Institute
Country [1] 295070 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Level 4, 99 Commercial Road, Melbourne Victoria 3004, Australia
Country
Australia
Secondary sponsor category [1] 293880 0
None
Name [1] 293880 0
Address [1] 293880 0
Country [1] 293880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296414 0
Alfred Health HREC
Ethics committee address [1] 296414 0
55 Commercial Road, Melbourne Victoria 3004, Australia
Ethics committee country [1] 296414 0
Australia
Date submitted for ethics approval [1] 296414 0
21/11/2016
Approval date [1] 296414 0
20/12/2016
Ethics approval number [1] 296414 0
547/16

Summary
Brief summary
Insulin pump therapy is a potential long-term treatment options in patients with type 1 diabetes not achieving optimal glycemic control. Compared to standard care insulin pump therapy is expensive and requires high levels of medical and patient input, and its use in Australia is rapidly increasing. Despite this the potential long-term effects of insulin pump therapy in patients with type 1 diabetes in comparison with standard of care is poorly documented, with no studies published with more than 5 years of follow-up.

The aim of this study is to review long term (5 to 16 years) follow-up clinic data relating to clinical outcomes (glycemic control, hypoglycaemia, weight, clinical service utilisation) between 2000 and 2016 of people commenced on insulin pump therapy compared to standard care which is people who have undergone formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011..

We intend to provide “real life” long term data to examine the efficacy and costs of on insulin pump therapy compared to modern standard care.
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 70806 0
A/Prof Esther Briganti
Address 70806 0
Baker Diabetes Clinical Services
Level 4, 99 Commercial Road, Melbourne Victoria 3004, Australia
Country 70806 0
Australia
Phone 70806 0
+61 3 8532 1838
Fax 70806 0
+61 3 8532 1899
Email 70806 0
[email protected]
Contact person for public queries
Name 70807 0
A/Prof Esther Briganti
Address 70807 0
Baker Diabetes Clinical Services
Level 4, 99 Commercial Road, Melbourne Victoria 3004, Australia
Country 70807 0
Australia
Phone 70807 0
+61 3 8532 1838
Fax 70807 0
+61 3 8532 1899
Email 70807 0
[email protected]
Contact person for scientific queries
Name 70808 0
A/Prof Esther Briganti
Address 70808 0
Baker Diabetes Clinical Services
Level 4, 99 Commercial Road, Melbourne Victoria 3004, Australia
Country 70808 0
Australia
Phone 70808 0
+61 3 8532 1838
Fax 70808 0
+61 3 8532 1899
Email 70808 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
SourceTitleYear of PublicationDOI
EmbaseLong-term effectiveness of continuous subcutaneous insulin infusion in the prevention of hypoglycemia in adults with type 1 diabetes.2019https://dx.doi.org/10.1089/dia.2019.0108
N.B. These documents automatically identified may not have been verified by the study sponsor.