Trial Review

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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
Sex
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
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
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
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
[email protected]
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
[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.