Skip to main content
OpenTrials
Completed

NCT Number: NCT03332472

Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)

To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1 diabetes mellitus (DM1) and regular metabolic control (HbA1c <8%) in multi-dose insulin treatment (MDI) measured HbA1c vs. conventional medical care.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga. Unidad de Diabetes

Málaga, 29010, Spain

About this study

The substitution of face-to-face visits for telematics visits has a similar effect on glycemic control (measured by HbA1c) in patients with DM1 treated with multiple daily doses of insulin (MDI) and regular metabolic control (HbA1c <8 %). It even saves costs and consumption of health resources, and improves the quality of life and satisfaction of subjects with DM1

To evaluate the effect of a 6-month Diabetic platform on telemedicine in patients with DM1 and regular metabolic control (HbA1c <8%) on MDI treatment in the following parameters:

A) Glycemic control: Mean glycemia, number of mild hypoglycemia / week, number of severe hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , Number of hospital admissions due to glycemic decompensation / 6 months.

B) Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).

C) Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life Questionnaire (DQoL). E) Stress: DDS questionnaire.

F) Costs and consumption of health resources:

-Cost-effectiveness (HbA1C)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with DM1 over 2 years of evolution.
  • Age ≥18 and <65 years.
  • HbA1c prior to inclusion of the study <8% (the measure being valid in the month prior to inclusion in the study)
  • Intensive insulin therapy with basal-bolus MDI.
  • Patients living in Andalusian
  • Patients candidates for telemonitoring.
  • Patients who have received written informed consent.

Exclusion criteria

  • Treatment with ISCI.
  • Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
  • Pregnancy or pregnancy planning.
  • Diabetes mellitus type 2.
  • Severe psychological disturbances.
  • Absence of collaboration (informed consent).
  • Patients who are participating in other clinical studies.

Treatment and study plan

Telemedicine Group

Other

Conventional Group

Other

Primary outcomes

  1. HbA1c

    Time frame: 6 months

    Glycosylated hemoglobin

Secondary outcomes

  1. Total daily dose of insulin

    Time frame: 6 months

    total daily doseof insulin (IU/day)

  2. Total daily dose of insulin by weight

    Time frame: 6 months

    Total daily dose by weight (IU / kg / day)

  3. Number of mild hypoglycaemia

    Time frame: 6 months

    Acude complications prior to V1: number of mild hypoglycaemia

  4. Number of severe hypoglycemia

    Time frame: 6 months

    Acute complications prior to V1: number of severe hypoglycemia

  5. Number of hyperglycemia greater than 250 mg / dl / week

    Time frame: 6 months

    Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week

  6. Number of episodes of ketosis number of episodes of ketoacidosis

    Time frame: 6 months

    Acute complications prior to V1: number of episodes of ketosis and number of episodes of ketoacidosis

  7. Number of hospital admissions due to glycemic decompensations

    Time frame: 6 months

    Acute complications prior to V1:number of hospital admissions due to glycemic decompensations.

  8. Fear of hypoglycemia: FH-15 scale

    Time frame: 6 months

    Hypoglycemia Fear test: FH-15 questionnaire (Annex)

  9. Quality of life

    Time frame: 6 months

    Diabetes Quality of Life Questionnaire (DQoL).

  10. Stress: DDS questionnaire

    Time frame: 6 months

    Diabetes Distress Scale (DDS) (Polonski et al, 2005)

  11. Time invested in the care of each patient

    Time frame: 6 months

    Costs and consumption of health resources: Time invested in the care of each patient in minutes

  12. Number of telephone calls

    Time frame: 6 months

    Costs and consumption of health resources: Number of telephone calls

  13. Number of face-to-face visits

    Time frame: 6 months

    Costs and consumption of health resources: Number of face-to-face visits

  14. Analytics performed in the center

    Time frame: 6 months

    Costs and consumption of health resources: Analytics performed in the center

  15. Analytic done in domestic scope with glucometer

    Time frame: 6 months

    Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer

  16. Cost of hypoglycaemic treatment (insulin)

    Time frame: 6 months

    Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros.

  17. Costs and consumption of health resources

    Time frame: 6 months

    Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations

  18. Costs associated with the time spent going to the patient's hospital and family members

    Time frame: 6 months

    Costs and consumption of health resources: costs associated with the time spent going to the patient's hospital and family members

  19. Costs associated with days lost due to complications.

    Time frame: 6 months

    Costs and consumption of health resources: costs associated with days lost due to complications.

  20. Mean blood glucose

    Time frame: 6 months

    Glycemic control: Mean blood glucose (mg / dL)

  21. Standard deviation

    Time frame: 6 months

    Glycemic control: Standard deviation.

Sponsors and collaborators

Lead sponsor

Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

Other

Registry information

Official study title

Evaluation of Telemedicine on Metabolic Control in the Care of Diabetes Mellitus Type 1 Patients in Multiple Doses of Insulin Treatment in Andalusian Community

Acronym: PLATEDIAN

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Nov 6, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.