Insulin intervention development for people with type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN13339678
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37237318/ Feasibility and acceptability (added 30/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-30
• Study Completion: 2021-03-31
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Initial interviews and testing:
1. Diagnosis of type 2 diabetes
2. 18 years or over

Randomized controlled feasibility study:
1. Diagnosis of type 2 diabetes
2. Aged 40-65 years
3. Identified by general practitioner as requiring insulin treatment, i.e. on maximum tolerated dose of 2 OADs and glycaemic control HbA1c >/=7.5% (58 mmols/mol) on two occasions

Exclusion Criteria

Initial interviews and testing:
1. Non-fluency in English
2. Severe mental illness

Randomized controlled feasibility study:
1. Non-fluency in English
2. Morbid obesity (BMI >/=35)
3. In employment that contraindicates insulin treatment, e.g. HGV driver
4. Severe depression, anxiety disorders, psychotic disorders, or personality disorders, or cognitive impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified