Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001138875
Ethics application status
Approved
Date submitted
24/10/2012
Date registered
26/10/2012
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Low carbohydrate diet vs carbohydrate counting in type 1 diabetes
Scientific title
A Comparison of a Low Carbohydrate Diet vs Carbohydrate Counting on Glycaemic Control, Renal Function and Quality of Life in Type 1 Diabetes– a pilot
Secondary ID [1] 281432 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 287685 0
Condition category
Condition code
Metabolic and Endocrine 288027 288027 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A low carbohydrate diet (50-75g of carbohydrate total per day patients choice of level within this range) over 12 weeks. Participants will be given information on carbohydrate amounts in foods and guidance on selecting up to 75g per day, with unlimited protein and free vegetables. Added fats will be encouraged to be limited and good choices in line with cardiocascular health advice. 8 participants will be randomised to this arm and will attend 4 group sessions to learn about the diet and matching insulin doses to this. These will be 1.5hrs once a week for the first 4 weeks of the intervention facilitated by a diabetes nurse and dietitian.
Intervention code [1] 285937 0
Lifestyle
Intervention code [2] 285939 0
Treatment: Other
Comparator / control treatment
Carbohydrate counting - current usual treatment over 12 weeks. 8 participants will be randomised to this arm and will attend 4 group sessions to learn about carbohydrate counting and matching insulin. This involves estimating carbohydrate content of each meal or snack and then using ratios to determine insulin dose required to match the meal. These will be 1.5hrs once a week for the first 4 weeks of the intervention facilitated by a diabetes nurse and dietitian.
Control group
Active

Outcomes
Primary outcome [1] 288234 0
Glycaemic control: Glucose excursions above 8 mmol/l and below 4mmol/l over 24 hours by continuous glucose monitoring (CGMS) and glycated haemoglobin (HbA1c)
Timepoint [1] 288234 0
3 months
Primary outcome [2] 288235 0
Kidney function - Albumin creatinine ratio
Timepoint [2] 288235 0
3 months
Primary outcome [3] 288236 0
Quality of Life - audit of diabetes dependant quality of life questionnaire (AddQol)
Timepoint [3] 288236 0
3 months
Secondary outcome [1] 299670 0
Diabetes self efficacy - using the diabetes empowerment scale (DES) questionnaire for diabetes
Timepoint [1] 299670 0
3 months
Secondary outcome [2] 299671 0
Blood lipid profile
Timepoint [2] 299671 0
3 months
Secondary outcome [3] 299672 0
Weight change from baseline by electronic scale
Timepoint [3] 299672 0
3 months

Eligibility
Key inclusion criteria
Type 1 diabetes mellitus on a suitable insulin regime for carbohydrate and insulin manipulation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breastfeeding women
Unstable glycaemic control – HbA1c over 85

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)
Participants will be enrolled in the study in the order they present and randomisation envelopes will be given out consecutively
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation). Numbers will then be put into sealed envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2013
Actual
2/04/2013
Date of last participant enrolment
Anticipated
Actual
24/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 4623 0
New Zealand
State/province [1] 4623 0
Wellington

Funding & Sponsors
Funding source category [1] 286199 0
Hospital
Name [1] 286199 0
Capital and Coast District Health Board
Country [1] 286199 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast District Health Board
Address
Private Bag 7902
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 285008 0
None
Name [1] 285008 0
Address [1] 285008 0
Country [1] 285008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288270 0
Health and Disability Ethics Committee Central
Ethics committee address [1] 288270 0
Ethics committee country [1] 288270 0
New Zealand
Date submitted for ethics approval [1] 288270 0
11/12/2012
Approval date [1] 288270 0
22/02/2013
Ethics approval number [1] 288270 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34867 0
Dr Jeremy Krebs
Address 34867 0
Diabetes Research Capital and Coast DHB Private Bag 7902 Wellington 6021
Country 34867 0
New Zealand
Phone 34867 0
+6448062458
Fax 34867 0
Email 34867 0
jeremy.krebs@ccdhb.org.nz
Contact person for public queries
Name 18114 0
Amber Parry Strong
Address 18114 0
Diabetes Research
Capital and Coast DHB
Private Bag 7902
Wellington 6021
Country 18114 0
New Zealand
Phone 18114 0
+6448062458
Fax 18114 0
Email 18114 0
amber.parry-strong@ccdhb.org.nz
Contact person for scientific queries
Name 9042 0
Amber Parry Strong
Address 9042 0
Diabetes Research
Capital and Coast DHB
Private Bag 7902
Wellington 6021
Country 9042 0
New Zealand
Phone 9042 0
+6448062458
Fax 9042 0
Email 9042 0
amber.parry-strong@ccdhb.org.nz

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.