Telemedicine
Conditions
Keywords
type 1 diabetes
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)
Interventions
OTHERTelemedicine group
OTHERConventional group
Sponsors
Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | Glycosylated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 severe hypoglycemia | 6 months | Acute complications prior to V1: number of severe hypoglycemia |
| 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 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 |
| Number of hospital admissions due to glycemic decompensations | 6 months | Acute complications prior to V1:number of hospital admissions due to glycemic decompensations. |
| Fear of hypoglycemia: FH-15 scale | 6 months | Hypoglycemia Fear test: FH-15 questionnaire (Annex) |
| Quality of life | 6 months | Diabetes Quality of Life Questionnaire (DQoL). |
| Stress: DDS questionnaire | 6 months | Diabetes Distress Scale (DDS) (Polonski et al, 2005) |
| 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 |
| Total daily dose of insulin | 6 months | total daily doseof insulin (IU/day) |
| 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 |
| Cost of hypoglycaemic treatment (insulin) | 6 months | Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros. |
| 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. |
| Mean blood glucose | 6 months | Glycemic control: Mean blood glucose (mg / dL) |
| Standard deviation | 6 months | Glycemic control: Standard deviation. |
| Number of telephone calls | 6 months | Costs and consumption of health resources: Number of telephone calls |
Countries
Spain
Outcome results
None listed