Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease
Condition: 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
MeSH terms: Alzheimer Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This randomized controlled trial is aimed at studying the effects of an eHealth intervention
      on improving metabolic control and other cardiovascular risk factors (obesity, lipidic
      profile and hypertension) as the approach to prevent or delay the process of cognitive
      impairment, and to reduce conversion rates to Alzheimer's disease (AD) in a sample of
      patients diagnosed of type 2 diabetes mellitus (T2D) and with mild cognitive impairment
      (MCI).

      For these purposes, the standard clinical treatment for this type of patients will be
      compared with two types of interventions (parallel groups): one aimed at promoting adherence
      to treatment through the use of a smart pillbox; and the other intervention will be based on
      the use of the smart pillbox plus and interactive digital platform allowing communication
      between patients and caregivers with healthcare professionals. Both interventions are
      targeted to improve adherence to treatment.

      The hypothesis is that the rate of conversion from MCI to AD will be higher in the control
      group than in the intervention groups (higher conversion rates are expected in control group,
      followed by the smart pillbox group, and lower conversion rates are expected in the group
      using the interactive digital platform and the smart pillbox).
    

Detailed description: 
      The objective of the DIALCAT randomized controlled trial is to study the effects of an
      eHealth intervention (smart pillbox, digital platform) on the progression of cognitive
      impairment evaluated by means of a neuropsychological examination, in a sample of elderly
      patients with type II diabetes (T2D) and mild cognitive impairment (MCI). As secondary goals,
      this research is intended to:

        1. Assess if the intervention improves the metabolic control of the study sample.

        2. Evaluate the effects of the intervention on the conversion rate (yes vs. no) from MCI to
           Alzheimer's' disease (AD).

        3. Compare the effectiveness of the interventions to reduce functional decline (quantified
           by a battery of neuropsychological tests [see detailed description below]) and the
           conversion rate to AD.

        4. Identify the clinical and analytical predictors (biomarkers) of conversion from MCI to
           AD.

      To this purposes, a total of 174 T2D patients with MCI (MMSE≥24) will be recruited with a
      18-month follow-up. Eligible patients will be randomized in a 1:1:1 ratio in one of the arms
      of the RCT (for randomization, a sex-by-sex-swapped sequence and the ApoE genotype will be
      used). The three groups will receive the following interventions:

      Arm 1: T2D patients (n = 58) with MCI, receiving treatment as usual (TAU) by their primary
      care physician/endocrinologist.

      Arm 2: T2D patients (n = 58) with MCI, receiving TAU and using a smart pillbox that allows to
      monitor adherence to treatment.

      Arm 3: T2D patients (n = 58) with MCI, receiving TAU, using the smart pillbox and receiving
      periodic feedback on their metabolic control and how to improve it by an endocrinologist via
      a digital platform.

      Since it is expected that the different factors related to the intervention will have an
      additive or synergistic effect, the hypothesis is that the cognitive impairment and
      progression of MCI to AD would be higher in arm 1, followed by arm 2 and, finally, arm 3.
    

Intervention name(s): Smart pillbox; Interactive digital platform
Intervention type(s): Device; Other
Intervention description(s): The smart electronic pillbox will monitor adherence to pharmacological treatment by means of registering time of medications intake. It will incorporate visual and auditory reminders for taking medications (all of them, being or not being inside the dispenser such as insulin or eye drops). The dispenser will also have sensors and alarms to ensure the proper preservation of the medicines contained. The dispenser will be recharged weekly by a trained pharmacist. Each dispenser will be identified unequivocally with one user, and it will be interconnected with a mobile application (app).; The digital interactive platform will allow communication between patients and caregivers and healthcare professionals. Its aims are to provide feedback and guidelines on treatment adherence and also, on how to better optimize treatment on cardiovascular risk factors. The platform will inform about medication dosages and intake schedule, healthy lifestyles related to diabetes, occurrence of adverse events, and it will also monitor patients' glycemic control. In this sense, several alarms are programmed to warn caregivers or even healthcare professionals when the patient has hyperglycemia or hypoglycaemia. The platform will provide too guidelines on how to treat hypo or hyperglycemia as well as most common adverse events, and it will describe reasons to have suffered it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 2 diabetes mellitus; Mild cognitive impairment; Alzheimer disease; Intervention; Clinical trial; mHealth; Smart electronic pillbox; Interactive digital platform