| Trial Acronym | My Diabetes and Me |
| Clinical Area | Diabetes |
| Trial Title | The clinical and cost-effectiveness of the DESMOND-ID education programme for adults with Intellectual disability and Type 2 Diabetes |
| Trial Status | Open to Recruitment |
| Trial Registration | https://www.isrctn.com/ISRCTN83150600 |
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Recruitment
Recruitment Target 450 Date Open to Recruitment January 2023 Recruitment 250 as of August 2024 Date Closed to Recruitment Ongoing -
Chief Investigator
Chief Investigator Professor Laurence Taggart, Ulster University -
Trial Design
2-stage parallel group randomised trial with an internal pilot, economic evaluation and process evaluation. STUDY POPULATION: 450 adults aged ≥18yrs; mild/moderate ID and T2D
RANDOMISATION PROCEDURES: All adults will be randomised to either the study intervention (DESMOND-ID) or Treatment As Usual (TAU) and allocated a unique participant ID number by the NICTU Statistics Department. Randomisation will be stratified by site only.
The primary outcome will be measured at 6, 12 and 18 months post randomisation. The 18 month time point is for internal pilot participants only.
Aim: To determine whether DESMOND-ID improves outcomes and is cost-effective compared to TAU in adults with ID and T2D. The primary objective is:
To conduct a UK based, multicentre, randomised control trial to determine the effectiveness of the DESMOND-ID programme on HbA1c levels (primary outcome) and a range of secondary outcomes compared to TAU.
The secondary objectives are:
-To determine the cost-effectiveness of the DESMOND-ID programme compared to TAU via a within-trial economic evaluation and a long-term model.
-To determine the facilitators, barriers and mechanisms of actions involved in the DESMOND-ID process via a process evaluation.
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Sponsor & Funder
Sponsor Ulster University Funder National Institute for Health and Care Research Health Technology Assessment