D-Med Study
Research type
Research Study
Full title
Evaluation of an electronic decision-support system, plus training with follow-up support and performance review, for the deintensification of potentially inappropriate medications (D-Med) to prevent overtreatment in the management of older frail people with type 2 diabetes: a 12-month follow-up cluster randomised trial
IRAS ID
280971
Contact name
Samuel Seidu
Contact email
ISRCTN Number
ISRCTN53221378
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
Evaluation of an electronic-based decision support system, plus training and support, for the deintensification of potentially inappropriate medications (D-Med) to prevent overtreatment in the management of older frail people with type 2 diabetes: a 12-month follow-up cluster randomised trial.
Many older people suffer from frailty with progressive age, characterised by a decline in both their physical and mental health and a number of health conditions requiring treatment. In type 2 diabetes, managing frailty means striking a balance to prevent over treatment with some diabetes medications which increase the risk of low blood sugars and lead to more falls, fractures and deaths. Guidelines are now in place detailing when to deintensify (stop, change or reduce) some diabetes medications in frail older people; however, these have not been well implemented in primary care. Pragmatic interventions are needed to address this problem.
Our study aims to address this problem by developing and evaluating an enhanced care intervention involving an electronic decision-support system, with training and follow-up support, to help primary care providers identify and manage their frail older type 2 diabetes patients more effectively. The study is funded by the NIHR Applied Research Collaboration East Midlands.
The primary objective will be to evaluate the effectiveness of the intervention on reducing the number of potentially inappropriate diabetes medications prescribed whilst secondary objectives will evaluate the effect on clinical outcomes and associated adverse events. As a cluster trial, practices (from different regions) and not patients will be recruited and randomised to either the control or intervention group. Database searches will find frail type 2 diabetes patients, aged 65 years and over, with blood sugar levels below the recommended targets. Then, relevant demographic, clinical and prescription pseudonymised data will be extracted for these patients at baseline, 6- and 12-months, and the two groups will be compared.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0163
Date of REC Opinion
12 Jul 2021
REC opinion
Favourable Opinion