Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease

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).

Conditions

• 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

Interventions

DEVICE

Smart pillbox

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).

OTHER

Interactive digital platform

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.

Sponsors & Collaborators

• Hospital Vall d'Hebron

  collaborator OTHER

• Consorci Sanitari de Terrassa

  collaborator OTHER

• Fundació Recerca Mútua Terrassa (FMT)

  collaborator UNKNOWN

• Clínica Universitària de la Fundació Universitària del Bages (FUB)

  collaborator UNKNOWN

• Althaia Xarxa Assistencial Universitària de Manresa

  collaborator OTHER

• Fundació Privada Hospital Asil de Granollers (HAG)

  collaborator UNKNOWN

• Consorci Hospitalari de Vic

  collaborator OTHER

• LambdaLoopers

  collaborator OTHER

• Universitat Politècnica de Catalunya

  collaborator OTHER

• Leitat

  collaborator UNKNOWN

• Mixestat

  collaborator UNKNOWN

• Meditecnologia

  collaborator UNKNOWN

• Parc Sanitari Pere Virgili

  lead OTHER

Principal Investigators

• Marco Inzitari, MD, PhD · Parc Sanitari Pere Virgili

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2020-04-15

Completion

2020-04-15

Countries

• Spain

Study Locations