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Trial record 1 of 5 for:    22187469 [PUBMED-IDS]
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Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN) (PLATEDIAN)

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ClinicalTrials.gov Identifier: NCT03332472
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Telemedicine Other: Telemedicine group Other: Conventional group Not Applicable

Detailed Description:

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)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Telemedicine group
Telematics visit in front of the conventional visit face to face
Other: Telemedicine group
Placebo Comparator: Conventional group
Group with conventional medical visit
Other: Conventional group



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]
    Glycosylated hemoglobin


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332472


Locations
Spain
Hospital Regional Universitario de Málaga. Unidad de Diabetes
Málaga, Spain, 29010
Sponsors and Collaborators
Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

Publications:

Responsible Party: Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
ClinicalTrials.gov Identifier: NCT03332472     History of Changes
Other Study ID Numbers: PLATEDIAN
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sociedad Andaluza de Endocrinología, Diabetes y Nutrición:
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases