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Trial registered on ANZCTR


Registration number
ACTRN12614000660684
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
24/06/2014
Date last updated
24/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
In search of the most effective protocol to treat hypoglycaemia in type 1 diabetes: a randomised trial testing 3 different hypoglycaemia treatment protocols for resolution of hypoglycaemia and symptoms in adolescents and adults with type 1 diabetes
Scientific title
In search of the most effective protocol to treat hypoglycaemia in type 1 diabetes: a randomised trial testing 3 different hypoglycaemia treatment protocols for resolution of hypoglycaemia and symptoms in adolescents and adults with type 1 diabetes
Secondary ID [1] 284183 0
Nil
Universal Trial Number (UTN)
Trial acronym
SEPTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 291281 0
Condition category
Condition code
Metabolic and Endocrine 291635 291635 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised cross-over trial of 3 treatment doses of glucose for hypoglycaemia (0.2 g/kg, 0.3 g/kg and 15 g).

As per protocol each treatment is administered as glucose tablets at onset of spontaneously occurring hypoglycaemia, and only repeated at 10 minutes if hypoglycaemia has not resolved. As blood glucose is very dynamic "a wash-out" is not really applicable, and hypoglycaemia had always resolved prior to any repeat episodes. Patients record on the treatment sheet when an episode occurs, what treatment is given and then blood glucose at specified intervals - it si unlikely they would complete the data sheet without adhering to treatment for that episode.
Intervention code [1] 288880 0
Treatment: Other
Comparator / control treatment
Randomised cross-over trial of 3 treatment doses of glucose for hypoglycaemia (0.2 g/kg, 0.3 g/kg and 15 g). 15 g is current standard treatment, 0.2 and 0.3 g/kg are comparator treatments
Control group
Dose comparison

Outcomes
Primary outcome [1] 291566 0
Blood glucose 10 miuntes after treatment, on supplied (and standardised) glucometer measured by participant
Timepoint [1] 291566 0
10 minutes
Secondary outcome [1] 307083 0
Change in blood glucose at 10 minutes, on supplied (and standardised) glucometer measured by participant
Timepoint [1] 307083 0
10 minutes
Secondary outcome [2] 307084 0
Proportion of episodes requiring repeat treatment at 10 minutes (given if glucose on supplied glucometer remained less than 4 mmol/L at 10 minutes)
Timepoint [2] 307084 0
10 minutes

Eligibility
Key inclusion criteria
Adults with type 1 diabetes, recieving insulin and having more than one episode of hypoglycaemia per week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. adrenal insufficiency
2. untreated hypothyroidism
3. clinical autonomic neuropathy
4. coeliac disease
5. Living alone

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)
Subjects recruited from diabetes clinic. One of three treatments randomly allocated by sealed envelope for each episode requiring treatment (up to 15 per subject)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Details of treatment dose and recording sheet written on each treatment episode form, placed in sealed envelope and then shuffled. for each subject, 5 envelopes for each treatment (15 envelopes altogether) provided. Envelopes then shuffled and numbered from 1 to 15, with subjects instructed to take the next numbered treatment episode envelope. This is simple randomisation, akin to dice-rolling. No stratification required.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
18/08/2011
Date of last participant enrolment
Anticipated
1/10/2012
Actual
22/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5857 0
New Zealand
State/province [1] 5857 0

Funding & Sponsors
Funding source category [1] 288808 0
Charities/Societies/Foundations
Name [1] 288808 0
New Zealand Society for the Study of Diabetes Nursing Development Grant
Country [1] 288808 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast District Health Board, Wellington Hospital
Address
Private Bag 7902
Wellington
New Zealand 6021
Country
New Zealand
Secondary sponsor category [1] 287507 0
None
Name [1] 287507 0
Address [1] 287507 0
Country [1] 287507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290657 0
Central Regional Ethics Committee
Ethics committee address [1] 290657 0
Central Regional Ethics Committee
Ministry of Health
PO Box 5013
1 the Terrace
Wellington 6145
Ethics committee country [1] 290657 0
New Zealand
Date submitted for ethics approval [1] 290657 0
Approval date [1] 290657 0
12/07/2011
Ethics approval number [1] 290657 0
CEN/10/09/042

Summary
Brief summary
The best treatment for episodes of hypoglycaemia has not been studied in detail and most guidelines have a small evidence base. The study aimed to investigate whether using an individualised dose of glucose, based on weight, rather than a fixed dose of 15 g, as currently recommended, would be more effective in resolving hypoglycaemia. Adult subjects with T1DM and frequent hypoglycaemia (more than one per week) were enrolled into this study. Treatment for each hypoglycaemia episode, defined as capillary glucose <4.0 mmol/L, was randomly assigned one of three protocols: 0.2 grams/kg and 0.3 grams/kg or15 grams of glucose (Dextro glucose tablets). Each subject received each treatment in random order for up to 15 hypoglycaemia episodes. Glucose was re-tested 10 minutes after treatment, with a repeat dose if < 4 mmol/L. The study shows 0.3 g/kg treatment dose resulted in a greater change in glucose and higher glucose at 10 minutes, with less need for extra treatment.
Trial website
Trial related presentations / publications
McTavish L, Wiltshire E, Krebs J. Weight based treatment is more effective for resolving hypoglycaemia in adults: a randomised trial. International Diabetes Federation, World Diabetes Congress, Melbourne, Australia, December 2013. Poster PD-0787
Public notes

Contacts
Principal investigator
Name 46630 0
Mr Lindsay McTavish
Address 46630 0
Department of Diabetes and Endocrinology
Capital and Coast District Health Board
Wellington Hospital
Private Bag 7902
Wellington 6021
Country 46630 0
New Zealand
Phone 46630 0
+64 4 3855999
Fax 46630 0
Email 46630 0
[email protected]
Contact person for public queries
Name 46631 0
Esko Wiltshire
Address 46631 0
Department of Paediatrics
University of Otago Wellington
PO Box 7343
Wellington South 6242
Country 46631 0
New Zealand
Phone 46631 0
+64 4 3855999/6912
Fax 46631 0
Email 46631 0
[email protected]
Contact person for scientific queries
Name 46632 0
Esko Wiltshire
Address 46632 0
Department of Paediatrics
University of Otago Wellington
PO Box 7343
Wellington South 6242
Country 46632 0
New Zealand
Phone 46632 0
+64 4 3855999/6912
Fax 46632 0
Email 46632 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
EmbaseWeight-based hypoglycaemia treatment protocol for adults with Type 1 diabetes: A randomized crossover clinical trial.2015https://dx.doi.org/10.1111/dme.12730
N.B. These documents automatically identified may not have been verified by the study sponsor.