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

NCT03578991 | Completed

• 2 other identifiers: DIALCAT COMRDI-B64574221423350COMRDI B64574221423350
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Type 2 diabetes mellitus; Mild cognitive impairment; Alzheimer disease; Intervention; Clinical trial; mHealth; Smart electronic pillbox; Interactive digital platform

Outcome Measures

Primary Outcomes (1)

• Change of score obtained in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

  The main variable of the study will be the score obtained in the RBANS in the different assessment periods. The RBANS was designed to be administered in adult population between 20 and 89 years. It is sensitive to the detection of cognitive disorder in degenerative and non-degenerative pathology. This battery evaluates 5 functions, by means of 12 subtests: 1) attention (repetition of digits and numerical key), 2) language (designation of drawings and semantic fluency), 3) visual-espacial / constructive ability (copy a figure and orientation of lines), 4) immediate memory (word learning and memory of the story) and 5) deferred memory (record of the list, word recognition, record of the story, record of the figure). The RBANS is a short battery (time of administration ≦30 minutes), and has two parallel forms of evaluation (forms A and B) to avoid the effect of learning.

  At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.

Secondary Outcomes (19)

• Cardiovascular risk factor: Hypertension.

  At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.

• Cardiovascular risk factor: Obesity.

  At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.

• Cardiovascular risk factor: Dyslipidemia.

  At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.

• Degree of diabetes control.

  At baseline (at the moment of the study enrollment), at 9 and an average of 18 months after enrollment.

• Usal medication.

  At baseline (at the moment of the study enrollment), and an average of 18 months after enrollment.

Study Arms (3)

Arm 1

NO INTERVENTION

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.

Arm 2

EXPERIMENTAL

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.

Device: Smart pillbox

Arm 3

EXPERIMENTAL

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.

Device: Smart pillbox; Other: Interactive digital platform

Interventions

Smart pillbox DEVICE

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).

Arm 2; Arm 3

Interactive digital platform OTHER

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.

Arm 3

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc Sanitari Pere Virgili: lead
• Hospital Vall d'Hebron: collaborator
• Consorci Sanitari de Terrassa: collaborator
• Fundació Recerca Mútua Terrassa (FMT): collaborator
• Clínica Universitària de la Fundació Universitària del Bages (FUB): collaborator
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator
• Fundació Privada Hospital Asil de Granollers (HAG): collaborator
• Consorci Hospitalari de Vic: collaborator
• LambdaLoopers: collaborator
• Universitat Politècnica de Catalunya: collaborator
• Leitat: collaborator
• Mixestat: collaborator
• Meditecnologia: collaborator

Study Sites (8)

Fundació Privada Hospital Asil de Granollers (HAG)

Granollers, Barcelona, 08402, Spain

Location

Fundació Althaia (FA)

Manresa, Barcelona, 08243, Spain

Location

Fundació Recerca Mútua Terrassa (FMT)

Terrassa, Barcelona, 08221, Spain

Location

Consorci Sanitari de Terrassa (CST)

Terrassa, Barcelona, 08227, Spain

Location

Consorci Hospitalari de Vic (CHV)

Vic, Barcelona, 08500, Spain

Location

Parc Sanitari Pere Virgili

Barcelona, 08023, Spain

Location

LambdaLoopers

Barcelona, 08034, Spain

Location

University Hospital Vall d'Hebron - Vall d'Hebron Institute of Research

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Marco Inzitari, MD, PhD

  Parc Sanitari Pere Virgili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 6, 2018
• Study Start: July 1, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)