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Trial registered on ANZCTR


Registration number
ACTRN12610001042033
Ethics application status
Approved
Date submitted
17/11/2010
Date registered
29/11/2010
Date last updated
29/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Insulin titration in General Practice: the TIME program
TIME = treat initiate manage educate
Scientific title
observational study in general practice of type 2 diabetics using a Diabetes Educator program to initiate and titrate insulin to improve HbA1c
Secondary ID [1] 253116 0
nil
Universal Trial Number (UTN)
U1111-1118-1962
Trial acronym
TIME trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes type 2 258675 0
Condition category
Condition code
Metabolic and Endocrine 258821 258821 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
diabetes education was provided on 3 occasions over 3 months and involved insulin initiation and review, titration and followup
insulin initiation and titration was by a standard local protocol provided in consultation with each patient's GP based on BSL diary entries
basal insulin was commenced at 10 units and titrated by 2 units every 3 days until the fasting BSL was <7
HbA1c was measured at baseline, 3 and 6 months
Intervention code [1] 257636 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259686 0
HbA1c was measured using Point of Care testing ie finger prick sample in the GP surgery.
testing apparatus was a BioRad In2It machine
Timepoint [1] 259686 0
baseline, 3 and 6 months
Secondary outcome [1] 266382 0
patient satisfaction was measured using a Diabetes Treatment Satisfaction Questionaire ( DTSQc Bradley)

qualitative interviews at exit from trial were conducted by a research nurse
Timepoint [1] 266382 0
DTSQc baseline and 6 months

Eligibility
Key inclusion criteria
type 2 diabetes
HbA1c >7%
inadequate control on oral medication
Minimum age
21 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
type 1 diabetes
use of GLP analogues in previous 6 months

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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)

Funding & Sponsors
Funding source category [1] 258092 0
Commercial sector/Industry
Name [1] 258092 0
Diabetes Australia
Address [1] 258092 0
W: diabetesaustralia.com.au

Level 2 103-105 Northbourne Avenue TURNER ACT 2612

GPO Box 3156 CANBERRA ACT 2601
Country [1] 258092 0
Australia
Primary sponsor type
University
Name
Spencer Gulf Rural Health School
Address
University of Adelaide
122 Frome St
Adelaide
SA
Australia 5005
Country
Australia
Secondary sponsor category [1] 257272 0
None
Name [1] 257272 0
Address [1] 257272 0
Country [1] 257272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260086 0
University of Adelaide, Human Research Ethics Committee
Ethics committee address [1] 260086 0
Research Ethics and Compliance Unit
Research Branch, Level 7, 115 Grenfell St
Adelaide
SA
The University of Adelaide, AUSTRALIA 5005
Ph : 8303 6028 (Mon - Thurs)
Fax : 8303 7325
Ethics committee country [1] 260086 0
Australia
Date submitted for ethics approval [1] 260086 0
26/03/2009
Approval date [1] 260086 0
26/03/2009
Ethics approval number [1] 260086 0
H-030-2009.

Summary
Brief summary
6 month observational study in general practice using a diabetes educator program to initiate and titrate insulin
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 31929 0
Address 31929 0
Country 31929 0
Phone 31929 0
Fax 31929 0
Email 31929 0
Contact person for public queries
Name 15176 0
DR David Mills
Address 15176 0
Spencer Gulf Rural Health School
122 Frome St Adelaide SA 5005
Country 15176 0
Australia
Phone 15176 0
+61 8 83034528
Fax 15176 0
Email 15176 0
pdavid.mills@adelaide.edu.au
Contact person for scientific queries
Name 6104 0
DR David Mills
Address 6104 0
Spencer Gulf Rural Health School
122 Frome St Adelaide SA 5005
Country 6104 0
Australia
Phone 6104 0
+61 8 83034528
Fax 6104 0
Email 6104 0
pdavid.mills@adelaide.edu.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