Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease (DIALCAT)
Patients Aged 65-85 (Both Included), Diagnosed of Mild Cognitive Impairment, Diagnosed of Type 2 Diabetes in Active Treatment (Hypoglycemic Agents) for a Period ≥5 Years
About this trial
This is an interventional prevention trial for Patients Aged 65-85 (Both Included) focused on measuring Type 2 diabetes mellitus, Mild cognitive impairment, Alzheimer disease, Intervention, Clinical trial, mHealth, Smart electronic pillbox, Interactive digital platform
Eligibility Criteria
Inclusion criteria:
- Patients diagnosed of diabetes mellitus type 2 with time evolution ⋝5 years.
- Age between 65 and 85 years old (both included).
- Ability to read and write.
- Active treatment with hypoglycemic agents.
- Diagnosed with mild cognitive impairment.
Exclusion Criteria:
- Familiar history of Alzheimer's' disease.
- Patients with any type of dementia.
- History of neurological or psychiatric conditions not stabilized that can substantially affect cognition.
Severe metabolic or systemic disease that affects the cognitive state. This includes:
- Unstable acute cardiovascular disease.
- Renal failure with glomerular filtration rate <30 ml/min/m2.
- Decompensated cirrhosis or liver failure.
- Untreated hypothyroidism or vitamin B12 deficiency. If known.
- Active cancer or chemotherapy treatment the previous year.
Treatment with drugs that alter the cognitive state, for example:
- Antipsychotic.
- Daily consumption of opioids.
- Benzodiazepines (BZD) long action (for example Diazepam). Benzodiazepines (BZD) short-acting at high doses such as Alprazolam at doses greater than 1 mg / day; Lorazepam at doses greater than 1 mg / day and Lormetazepam at doses greater than 1 mg / day.
- Fentanil patches in doses greater than 2.5 mg every 72 h.
- Gabapentin in doses greater than 600 mg / day.
- Pregabalin in doses greater than 50 mg / day.
- Amitriptyline in doses greater than 25 mg / day.
- Limitations of mobility that can avoid or restrict the application or evaluation of the intervention.
- Patients with other types of diabetes: diabetic mellitus type 1, LADA; MODY
- Unstable advanced diabetic retinopathy
- Patients with serious uncorrected sensory deficits that make assessment impossible (blindness, deafness).
- Patients with access to other online platforms for patients.
- Patients with access to other intelligent electronic dispensing devices for improved adherence to treatment.
Sites / Locations
- Fundació Privada Hospital Asil de Granollers (HAG)
- Fundació Althaia (FA)
- Fundació Recerca Mútua Terrassa (FMT)
- Consorci Sanitari de Terrassa (CST)
- Consorci Hospitalari de Vic (CHV)
- Parc Sanitari Pere Virgili
- LambdaLoopers
- University Hospital Vall d'Hebron - Vall d'Hebron Institute of Research
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Arm 1
Arm 2
Arm 3
Control group - Treatment as usual: Type 2 diabetic patients with mild cognitive impairment who will receive the standard clinical treatment recommended by their primary care physician/endocrinologist.
Intervention - Smart pillbox: Type 2 diabetic patients with mild cognitive impairment receiving the standard clinical treatment recommended by their primary care physician/endocrinologist, plus the use of a smart pillbox.
Intervention - Smart pillbox & Interactive digital platform: Description: Type 2 diabetic patients with mild cognitive impairment receiving the standard clinical treatment recommended by their primary care physician/endocrinologist, plus the use of a smart pillbox and an interactive digital platform.