Dishabituation as a treatment for impaired awareness of hypoglycaemia in type 1 diabetes

Not Applicable

Completed

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine; Type 1 diabetes mellitus

• Registration Number: ISRCTN15236211
• Lead Sponsor: niversity of Dundee/NHS Tayside

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-25
• Study Completion: 2019-08-02
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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
11. Physical ability that may limit exercise
12. Inability to give consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified