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Trial registered on ANZCTR


Registration number
ACTRN12610000797077
Ethics application status
Approved
Date submitted
20/09/2010
Date registered
24/09/2010
Date last updated
28/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study Examining the Efficacy of a Support Algorithm for Commencing Patients with Type 2 Diabetes on a Basal / Prandial Insulin Regimen in the Primary Care Setting With Professional Continuous Glucose Monitoring as an Adjunct.
Scientific title
A Pilot Study Examining the Efficacy of a Support Algorithm for Commencing Patients with Type 2 Diabetes on a Basal / Prandial Insulin Regimen in the Primary Care Setting With Professional Continuous Glucose Monitoring as an Adjunct.
Secondary ID [1] 252719 0
None.
Universal Trial Number (UTN)
Trial acronym
INITIATION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 258213 0
Condition category
Condition code
Metabolic and Endocrine 258391 258391 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
glulisine and glargine insulin and continuous glucose monitoring. Glargine insulin is to be administered subcutaneously (SC) once daily for 24 weeks. Glulisine is to be administered subcutaneously (SC) once daily initially for a maximum of 20 weeks. Dosing of the insulin will be dependent upon the subjects glucose levels. Subjects are to be randomised to continuous glucose monitoring or conventional glucose monitoring. The frequency of the monitoring will be according to a pre-specified schedule which will take into account the subject's glucose levels.
Intervention code [1] 257229 0
Treatment: Drugs
Intervention code [2] 257255 0
Treatment: Devices
Comparator / control treatment
Primary Intervention:None for insulin.
Secondary Intervention:Conventional glucose monitoring with multiple daily fingerpricks as comparator for continous glucose monitoring.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259233 0
The aim of the proposed study is to evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting. The primary outcome is to be the change in Haemoglobin A1c (HbA1c) at 12 and 24 weeks compared with baseline.
Timepoint [1] 259233 0
12 weeks and 24 weeks from baseline
Secondary outcome [1] 265638 0
To evaluate the relative glycaemic benefit of retrospective Continuous Glucose Monitoring (CGM) incomparison with conventional monitoring by fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting. This secondary outcome is to be assessed by comparing the change in HbA1c between baseline , 12 and 24 weeks in the continuous glucose monitoring group with the conventional glucose monitoring group.
Timepoint [1] 265638 0
12 weeks and 24 weeks from baseline.
Secondary outcome [2] 265671 0
To evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting upon glycaemia as determined by the secondary endpoint: Retrospective Continuous Glucose Monitoring (CGM) time spent in low (<4.0mmol/L), target (4.0-10.0mmol/L) and high (>10.0mmol/L) glucose range.
Timepoint [2] 265671 0
12 weeks and 24 weeks from baseline.
Secondary outcome [3] 265672 0
To evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting upon the secondary endpoint: incidence of severe hypoglycaemia (hypoglycaemia rresulting in loss of consciousness or requiring third party assistance)
Timepoint [3] 265672 0
12 weeks and 24 weeks from baseline.
Secondary outcome [4] 265673 0
To evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting upon the secondary endpoint: change in weight, BMI and waist-to-hip ratio at 12 weeks and 24 weeks compared with baseline.
Timepoint [4] 265673 0
12 weeks and 24 weeks from baseline.
Secondary outcome [5] 265681 0
To evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting upon the secondary endpoint: change in quality of life as measured by questionnaires Short Form 36 health survey questionnaire (SF-36) and Audit of Diabetes-Dependent Quality of Life (ADDQoL).
Timepoint [5] 265681 0
12 weeks and 24 weeks from baseline.
Secondary outcome [6] 265682 0
To evaluate the relative glycaemic benefit of retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting. This secondary endpoint is to be assessed by comparing the change in CGM time spent in low (<4.0mmol/L), target (4.0-10.0mmol/L) and high (>10.0mmol/L) glucose range.
Timepoint [6] 265682 0
12 weeks and 24 weeks from baseline.
Secondary outcome [7] 265683 0
To evaluate the relative glycaemic benefit of retrospective Continuous Glucose Monitoring (CGM) incomparison with conventional monitoring by fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting. This secondary endpoint is to be assessed by comparing the incidence of severe hypoglycaemia (hypoglycaemia rresulting in loss of consciousness or requiring third party assistance)
Timepoint [7] 265683 0
12 weeks and 24 weeks from baseline.
Secondary outcome [8] 265684 0
To evaluate the relative benefit on weight gain of retrospective Continuous Glucose Monitoring (CGM) incomparison with conventional monitoring by fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting. This secondary endpoint is to be assessed by comparing the
change in weight, Body Mass Index (BMI) and waist-to-hip ratio (WHR) at 12 weeks and 24 weeks compared with baseline.
Timepoint [8] 265684 0
12 weeks and 24 weeks from baseline.
Secondary outcome [9] 265685 0
To evaluate the relative benefit on quality of life of retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting. This secondary endpoint is to be assessed by comparing the change in quality of life as measured by questionnaires SF36 and ADDQoL.
Timepoint [9] 265685 0
12 weeks and 24 weeks from baseline.
Secondary outcome [10] 265686 0
To evaluate the relative glycaemic benefit of retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting upon glycaemia. This secondary endpoint is to be assessed by comparing the time taken to achieve target glycaemia as determined by HbA1c of 7% or less.
Timepoint [10] 265686 0
12 weeks and 24 weeks from baseline.
Secondary outcome [11] 265687 0
The aim of the proposed study is to evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting upon glycaemia. This secondary endpoint is the proportion of subjects acheiving an HbA1c of 7% or less.
Timepoint [11] 265687 0
12 weeks and 24 weeks from baseline.
Secondary outcome [12] 265688 0
To evaluate the relative glycaemic benefit of retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting upon glycaemia. This secondary endpoint is to be assessed by comparing the proportion of subjects acheiving an HbA1c of 7% or less.
Timepoint [12] 265688 0
12 weeks and 24 weeks from baseline.
Secondary outcome [13] 265689 0
To evaluate, as a secondary endpoint ,the relative dose of insulin required in subjects monitored by retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting.
Timepoint [13] 265689 0
12 weeks and 24 weeks from baseline.
Secondary outcome [14] 265690 0
To evaluate, as a secondary endpoint, the clinical utility of the monitoring technologies in subjects monitored by retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting as determined by a questionnaire.
Timepoint [14] 265690 0
24 weeks
Secondary outcome [15] 265691 0
To evaluate, as a secondary endpoint ,the proportion of subjects, monitored by retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings with regard to the initiation and titration of insulin in the primary care setting who were deemed to require ani njection of short acting insulin in addition to the injection of basal insulin.
Timepoint [15] 265691 0
12 weeks and 24 weeks
Secondary outcome [16] 265692 0
To evaluate, as a secondary endpoint ,the total time spent by a health professional with subjects, monitored by retrospective Continuous Glucose Monitoring (CGM) in comparison with conventional monitoring using fingerprick glucose readings.
Timepoint [16] 265692 0
24 weeks

Eligibility
Key inclusion criteria
Type 2 diabetes patients who are insulin naive. Age>18 Years<80 Years. At least 2 oral hypoglycaemic agents (metformin, sulphonylurea, Thiazolidindiones) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary if the patient is on less than 2 oral hypoglycaemic agents. The doses of the oral hypoglycaemic agents should be stable for at least 3 months prior to enrollment into the study. Haemoglobin A1c(HbA1c)>7.0%. Willing to monitor glucose levels at least twice daily. Willing to commence insulin and comply with follow-up.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes.
Evidence of satisfactory fasting glucose levels (mean <6.0mmol/L) with post-prandial hyperglycaemia (mean >10.0mmol/L).
Previous or current treatment with insulin (excluding the short term (<2weeks) use of insulin in acute illness or during hospitalization).
Non-English speaking.
Significant cognitive impairment.
Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin.
Significant renal impairment: estimated glomerular filtration rate (egfr)< 20.
Any recent (<3months) or ongoing life-threatening illness.
Needle phobia.
Pregnancy or planned pregnancy.
Major psychiatric disorder.

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 concealment will be done via opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257675 0
Commercial sector/Industry
Name [1] 257675 0
Medtronic
Country [1] 257675 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Aventis
Address
Talavera Corporate Centre - Building D | 12-24 Talavera Road Macquarie Park NSW AUSTRALIA 2113
Country
Australia
Secondary sponsor category [1] 256890 0
University
Name [1] 256890 0
National Health and Medical Research Council (NHMRC) Clinical Centre for Research Excellence (CCRE ) in Diabetes
Address [1] 256890 0
University of Melbourne Dept of Medicine,
4th Floor Clinical Sciences Building,
St Vincent's Public Hospital,
Cnr Princess and Regent st
Fitzroy, Victoria
3065
Country [1] 256890 0
Australia
Other collaborator category [1] 251528 0
Other Collaborative groups
Name [1] 251528 0
Baker-International Diabetes heart Institute
Address [1] 251528 0
75 Commercial Road
Melbourne, Victoria 3004
Country [1] 251528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259702 0
St Vincent's Hospital
Ethics committee address [1] 259702 0
Research Governance Unit,
Aikenhead Wing, Level 5,
St Vincent's Hospital,
27 Victoria Pde,
P.O. Box 2900,
Fitzroy, Vic, 3065
Australia
Ethics committee country [1] 259702 0
Australia
Date submitted for ethics approval [1] 259702 0
26/08/2010
Approval date [1] 259702 0
Ethics approval number [1] 259702 0

Summary
Brief summary
The purpose of this research project is to evaluate a plan of action designed for general practitioners and practice nurses to safely and efficiently start patients with Type 2 diabetes on insulin injections who have high sugar (glucose) levels despite taking tablets.

To be eligible to take part in this study subjects must have Type 2 diabetes; be aged between 18-80 years old; are on at least two diabetes tablets at the highest doses that they are able to tolerate and that these doses have been unchanged over the last 3 months, or based on the opinion of the general practitioner who normally cares for the patient insulin, is required to ensure ensure their health health. The subject must have a HbA1c (a simple laboratory measurement on blood that reflects average glucose levels in a person's blood over the previous three months) between 7.5-10.5% which indicates less than satisfactory diabetic control; and must have never taken insulin before. Women of childbearing age must not get pregnant during the study. There will be up to 142 subjects recruited for this study across 16 sites in Victoria Australia only.

Participating subjects will be commenced on insulin initially with a single injection of an insulin (Glargine) which lasts for 24 hours. The dose will then be adjusted to match the subject’s needs. If necessary, because sugar levels rise after meals despite providing an appropriate dose of the long acting insulin, a second injection of a short acting insulin (Glulisine) will be added in to coincide with the subject’s biggest meal for the day.

A second purpose of this study is to determine if a new device that provides information regarding a patient’s glucose levels continuously is helpful in guiding treatment that results in better control of diabetes when compared to current methods for monitoring glucose levels by finger-prick readings.

The study will be looking to see if the protocol used improves sugar levels as measured by a fall in HbA1c which will be measured at the start of a subject's involvement in the study, at 12 weeks and at 24 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31661 0
Address 31661 0
Country 31661 0
Phone 31661 0
Fax 31661 0
Email 31661 0
Contact person for public queries
Name 14908 0
Dr David O'Neal
Address 14908 0
University of Melbourne Department of Medicine,
St Vincent's Public Hospital,
Cnr Princess and Regent st
Fitzroy,
Victoria, 3065
Country 14908 0
Australia
Phone 14908 0
+61 3 9288 2574
Fax 14908 0
+61 3 92882581
Email 14908 0
dno@unimelb.edu.au
Contact person for scientific queries
Name 5836 0
Dr David O'Neal
Address 5836 0
University of Melbourne Department of Medicine,
St Vincent's Public Hospital,
Cnr Princess and Regent st
Fitzroy,
Victoria, 3065
Country 5836 0
Australia
Phone 5836 0
+61 3 9288 2574
Fax 5836 0
+61 3 92882581
Email 5836 0
dno@unimelb.edu.au

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
EmbaseAn exploratory trial of insulin initiation and titration among patients with type 2 diabetes in the primary care setting with retrospective continuous glucose monitoring as an adjunct: INITIATION study protocol.2014https://dx.doi.org/10.1186/1471-2296-15-82
EmbaseImpact of insulin initiation on glycaemic variability and glucose profiles in a primary healthcare Type 2 diabetes cohort: Analysis of continuous glucose monitoring data from the INITIATION study.2016https://dx.doi.org/10.1111/dme.12979
EmbaseHypoglycemia in people with type 2 diabetes and CKD.2019https://dx.doi.org/10.2215/CJN.11650918
N.B. These documents automatically identified may not have been verified by the study sponsor.