Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)
- Conditions
- Telemedicine
- Interventions
- Other: Conventional groupOther: Telemedicine group
- Registration Number
- NCT03332472
- Lead Sponsor
- 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional group Conventional group Group with conventional medical visit Telemedicine group Telemedicine group Telematics visit in front of the conventional visit face to face
- Primary Outcome Measures
Name Time Method HbA1c 6 months Glycosylated hemoglobin
- Secondary Outcome Measures
Name Time Method Quality of life 6 months Diabetes Quality of Life Questionnaire (DQoL).
Mean blood glucose 6 months Glycemic control: Mean blood glucose (mg / dL)
Total daily dose of insulin 6 months total daily doseof insulin (IU/day)
Number of severe hypoglycemia 6 months Acute complications prior to V1: number of severe hypoglycemia
Number of episodes of ketosis number of episodes of ketoacidosis 6 months Acute complications prior to V1: number of episodes of ketosis and number of episodes of ketoacidosis
Cost of hypoglycaemic treatment (insulin) 6 months Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros.
Standard deviation 6 months Glycemic control: Standard deviation.
Total daily dose of insulin by weight 6 months Total daily dose by weight (IU / kg / day)
Number of mild hypoglycaemia 6 months Acude complications prior to V1: number of mild hypoglycaemia
Number of hyperglycemia greater than 250 mg / dl / week 6 months Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week
Number of hospital admissions due to glycemic decompensations 6 months Acute complications prior to V1:number of hospital admissions due to glycemic decompensations.
Time invested in the care of each patient 6 months Costs and consumption of health resources: Time invested in the care of each patient in minutes
Number of telephone calls 6 months Costs and consumption of health resources: Number of telephone calls
Fear of hypoglycemia: FH-15 scale 6 months Hypoglycemia Fear test: FH-15 questionnaire (Annex)
Stress: DDS questionnaire 6 months Diabetes Distress Scale (DDS) (Polonski et al, 2005)
Number of face-to-face visits 6 months Costs and consumption of health resources: Number of face-to-face visits
Analytics performed in the center 6 months Costs and consumption of health resources: Analytics performed in the center
Analytic done in domestic scope with glucometer 6 months Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer
Costs and consumption of health resources 6 months Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations
Costs associated with the time spent going to the patient's hospital and family members 6 months Costs and consumption of health resources: costs associated with the time spent going to the patient's hospital and family members
Costs associated with days lost due to complications. 6 months Costs and consumption of health resources: costs associated with days lost due to complications.
Trial Locations
- Locations (1)
Hospital Regional Universitario de Málaga. Unidad de Diabetes
🇪🇸Málaga, Spain