ISRCTN15236211
Completed
N/A
Dishabituation as a treatment for impaired awareness of hypoglycaemia in type 1 diabetes: a randomised cross over study
niversity of Dundee/NHS Tayside0 sites12 target enrollmentOctober 25, 2017
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 1 diabetes
- Sponsor
- niversity of Dundee/NHS Tayside
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31942669/ results (added 04/09/2020) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33532608/ (added 17/08/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults \=18 and \= 55 years
- •2\. Type 1 diabetes
- •3\. \> 5 years disease duration
- •4\. HbA1c \< 75 mmol/l
- •5\. On intensive insulin therapy (CSII or MDI)
- •6\. Impaired awareness of hypoglycaemia (Gold score \=4 or Modified Clark score\=4 or DAFNE hypoglycaemia awareness rating 2 or 3\)
Exclusion Criteria
- •1\. Competitive sportsman/woman
- •2\. History of significant heart disease
- •3\. Treatment with beta blockers
- •4\. Renal impairment (eGFR\<60\)
- •5\. History of significant lung disease – that limits exercise
- •6\. History of significant neurological disease – including seizures second to hypoglycaemia
- •7\. High risk foot disease
- •8\. Previous amputation of toes/foot/leg
- •9\. Pregnant women or breast feeding mothers
- •10\. Participation in HIT or equivalent in past 6 months
Outcomes
Primary Outcomes
Not specified
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