Prevention of Functional Decline by Multimodal Intervention in Older Patients with Diabetes

Diabetes is highly prevalent in older subjects, affecting more than 25% of people over the age of 65. Screening, intervention, and monitoring of older subjects with diabetes requires facing complexity. Older diabetic patients are at greater risk of macro-vascular cardiovascular (CV) complications (myocardial infarction, stroke, peripheral arterial disease). Because of micro-vascular complications of diabetes (falls because of neuropathy, walking limitation because of peripheral artery disease or leg amputation, blindness, etc.), coexisting chronic disease, and consequent polypharmacy, older subjects with diabetes are at dramatically greater risk of disability and functional loss. Older diabetic patients have higher rates of premature death (4.6 years earlier), functional disability, accelerated muscle loss, and develop disability 6 to 7 years earlier than peers without diabetes. Too often, in routine clinical practice, the decision-making process is characterized by a fundamental dilemma: the older diabetic patient for whom the clinician is recommending treatment according to the Guidelines is quite different from the inclusion criteria adopted in the studies the guidelines are based on. Last, but not least, older patients often underestimate their risk of adverse outcomes. Care incorporating patient preferred/reported outcome may facilitate communication concerning the clinical course of diabetes and can increase the attention and participation of patients and caregivers. Indeed, a growing proportion of older diabetic subjects give higher importance to outcomes such as functional independence and related quality of life than on short-term complications or survival. Not to mention that also the preference for a specific functional outcome differs from patient to patient.

In this context, the conventional approach to the diabetic patient - focusing primarily on metabolic and CV risk factor control - does not meet the needs of older diabetic subjects and of their caregivers. Comprehensive Geriatric Assessment (CGA) is an effective tool for the holistic evaluation of the older patients through a comprehensive assessment of the physical, psychological, functional and socio-economic dimensions. Thus, CGA is intended to guide an overall approach to care from the determination of targets and therapeutic approaches to identification of patient's ability for diabetes self-management, from the aspect of patient's preferences and needs to the improvement or maintenance of functions and residual ability. However, CGA in older diabetic subjects is still predominantly adopted only to determine targets for glucose and CV risk factor levels A knowledge gap exists regarding the risk of functional dependency in older diabetic patients and the impact of CGA on the achievement of easily calculated and objective patient-centered outcomes.

METHODOLOGY Study design This project consists of a multicenter parallel groups randomized controlled trial conducted in three diabetological outpatient clinics in the University Centers in Cagliari, Ferrara, and Milan, Italy.

Participants Patients will be eligible if affected by diabetes and aged ≥75 years. Inclusion criteria: Age ≥75 years; diagnosis of diabetes mellitus; functional limitation defined as a Short Physical Performance Battery (SPPB) score between 4 (included) and 9 (included), and willingness to participate in the study. Exclusion criteria: severe disability in basic activity of daily living (dependency in 3 or more activities), not being resident in the hospital catchment area; residence in long-term care; diagnosis of schizophrenia, other psychotic or bipolar disorder, or severe cognitive impairment (MMSE score < 21/30); alcohol abuse (> 14 drinks per week); cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., the early stage breast or prostate cancer); respiratory insufficiency requiring regular use of supplemental oxygen; recent (< 6 months) myocardial infarction; class IV NYHA heart failure; severe chronic kidney disease (stage V, dialysis); decompensated liver cirrhosis, inability or unwillingness to provide informed consent. Recruitment All patients attending the diabetological outpatient clinics will be screened for potential participation in the study. Specifically trained researchers embedded in the medical units will assess participants for inclusion and exclusion criteria. Potentially eligible participants who agreed to participate will be finally evaluated with the Short Physical Performance Battery for final inclusion in the study. Patients with a SPPB score between 4 and 9, after giving written consent will be randomized to intervention or control group with a 1:1 ratio.

Randomisation. A secure internet-based system to randomize individual participants one to one between the intervention and control groups, with stratification by center, will be used.