Hospital Regional Universitario de Málaga. Unidad de Diabetes
Málaga, 29010, Spain
NCT Number: NCT03332472
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Málaga, 29010, Spain
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Glycosylated hemoglobin
Time frame: 6 months
total daily doseof insulin (IU/day)
Time frame: 6 months
Total daily dose by weight (IU / kg / day)
Time frame: 6 months
Acude complications prior to V1: number of mild hypoglycaemia
Time frame: 6 months
Acute complications prior to V1: number of severe hypoglycemia
Time frame: 6 months
Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week
Time frame: 6 months
Acute complications prior to V1: number of episodes of ketosis and number of episodes of ketoacidosis
Time frame: 6 months
Acute complications prior to V1:number of hospital admissions due to glycemic decompensations.
Time frame: 6 months
Hypoglycemia Fear test: FH-15 questionnaire (Annex)
Time frame: 6 months
Diabetes Quality of Life Questionnaire (DQoL).
Time frame: 6 months
Diabetes Distress Scale (DDS) (Polonski et al, 2005)
Time frame: 6 months
Costs and consumption of health resources: Time invested in the care of each patient in minutes
Time frame: 6 months
Costs and consumption of health resources: Number of telephone calls
Time frame: 6 months
Costs and consumption of health resources: Number of face-to-face visits
Time frame: 6 months
Costs and consumption of health resources: Analytics performed in the center
Time frame: 6 months
Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer
Time frame: 6 months
Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros.
Time frame: 6 months
Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations
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
Time frame: 6 months
Costs and consumption of health resources: costs associated with days lost due to complications.
Time frame: 6 months
Glycemic control: Mean blood glucose (mg / dL)
Time frame: 6 months
Glycemic control: Standard deviation.
Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
Other
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
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.
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