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Clinical Trials/ISRCTN15236211
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)

Registry
who.int
Start Date
October 25, 2017
End Date
August 2, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Dundee/NHS Tayside

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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