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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Telemedicine

Intervention / Treatment
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* Other: Telemedicine group
* Other: Conventional group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine group<br>Telematics visit in front of the conventional visit face to face | Other: Telemedicine group<br> <br> |
| Placebo Comparator: Conventional group<br>Group with conventional medical visit | Other: Conventional group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Glycosylated hemoglobin | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total daily dose of insulin | total daily doseof insulin (IU/day) | 6 months | 
| Total daily dose of insulin by weight | Total daily dose by weight (IU / kg / day) | 6 months | 
| Number of mild hypoglycaemia | Acude complications prior to V1: number of mild hypoglycaemia | 6 months | 
| Number of severe hypoglycemia | Acute complications prior to V1: number of severe hypoglycemia | 6 months | 
| Number of hyperglycemia greater than 250 mg / dl / week | Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week | 6 months | 
| Number of episodes of ketosis number of episodes of ketoacidosis | Acute complications prior to V1: number of episodes of ketosis and number of episodes of ketoacidosis | 6 months | 
| Number of hospital admissions due to glycemic decompensations | Acute complications prior to V1:number of hospital admissions due to glycemic decompensations. | 6 months | 
| Fear of hypoglycemia: FH-15 scale | Hypoglycemia Fear test: FH-15 questionnaire (Annex) | 6 months | 
| Quality of life | Diabetes Quality of Life Questionnaire (DQoL). | 6 months | 
| Stress: DDS questionnaire | Diabetes Distress Scale (DDS) (Polonski et al, 2005) | 6 months | 
| Time invested in the care of each patient | Costs and consumption of health resources: Time invested in the care of each patient in minutes | 6 months | 
| Number of telephone calls | Costs and consumption of health resources: Number of telephone calls | 6 months | 
| Number of face-to-face visits | Costs and consumption of health resources: Number of face-to-face visits | 6 months | 
| Analytics performed in the center | Costs and consumption of health resources: Analytics performed in the center | 6 months | 
| Analytic done in domestic scope with glucometer | Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer | 6 months | 
| Cost of hypoglycaemic treatment (insulin) | Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros. | 6 months | 
| Costs and consumption of health resources | Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations | 6 months | 
| Costs associated with the time spent going to the patient's hospital and family members | Costs and consumption of health resources: costs associated with the time spent going to the patient's hospital and family members | 6 months | 
| Costs associated with days lost due to complications. | Costs and consumption of health resources: costs associated with days lost due to complications. | 6 months | 
| Mean blood glucose | Glycemic control: Mean blood glucose (mg / dL) | 6 months | 
| Standard deviation | Glycemic control: Standard deviation. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes