Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study

Clinical Care/Education/Nutrition/Psychosocial Research

Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA_1c in Andalusia (Spain): PLATEDIAN Study

Maria S. Ruiz de Adana¹,²,³,
Maria Rosa Alhambra-Expósito⁴,⁵,
Araceli Muñoz-Garach²,⁶,
Inmaculada Gonzalez-Molero¹,²,³,
Natalia Colomo¹,²,³ ⇑,
Isabel Torres-Barea⁷,
Manuel Aguilar-Diosdado⁸,⁹,
Florentino Carral¹⁰,
Manuel Serrano¹¹,
Maria A. Martínez-Brocca¹²,¹³,
Ana Duran¹⁴ and
Rafael Palomares⁴,⁵, on behalf of the Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition)*

¹Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain
²Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain
³Ciber de Diabetes y Enfermedades Metabólicas (CIBERDEM), Madrid, Spain
⁴Endocrinology and Nutrition Department, Hospital Universitario Reina Sofía, Córdoba, Spain
⁵Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Córdoba, Spain
⁶Endocrinology and Nutrition Department, Hospital Universitario Virgen de la Victoria, Málaga, Spain
⁷Endocrinology and Nutrition Department, Hospital Universitario de Jerez, Jerez, Cádiz, Spain
⁸Endocrinology and Nutrition Department, Hospital Universitario Puerta del Mar, Cádiz, Spain
⁹Biomedical Institute of Research of Cadiz (INIBICA), Cadiz, Spain
¹⁰Endocrinology and Nutrition Department, Hospital Universitario Puerto Real, Puerto Real, Cádiz, Spain
¹¹Endocrinology and Nutrition Department, Complejo Hospitalario de Jaén, Jaén, Spain
¹²Endocrinology and Nutrition Department, Hospital Universitario Virgen Macarena, Sevilla, Spain
¹³Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Consejo Superior de Investigaciones Científicas/Universidad de Sevilla, Sevilla, Spain
¹⁴Medical Department, Sanofi Spain, Barcelona, Spain

Diabetes Care 2020 Feb; 43(2): 337-342. https://doi.org/10.2337/dc19-0739

Table 1

Participant characteristics at baseline

	CC (n = 167)	IC (n = 163)	P
Age (years), mean (SD)	36.22 (10.78)	33.78 (9.77)	0.581
Female, n (%)	73 (43.7)	73 (44.8)	0.758
Marital status, n (%)
Single	67 (40.1)	77 (47.2)	0.102
Relationship	24 (14.4)	26 (16.0)
Married	67 (40.1)	54 (33.1)
Divorced	8 (4.8)	4 (2.5)
Widowed	1 (0.6)	2 (1.2)
Education, n (%)
Without studies	0 (0.0)	1 (0.6)	0.580
Primary education	32 (19.2)	13 (8.0)
Secondary education	37 (22.2)	35 (21.5)
Vocational education and training	39 (23.4)	50 (30.7)
University studies	49 (23.3)	61 (37.4)
Postgraduate studies	10 (6.0)	1 (0.6)
Work, n (%)
Employed	80 (47.9)	67 (41.1)	0.425
Self-employed	15 (9.0)	16 (9.8)
Disability	5 (3.0)	0 (0.0)
Student	17 (10.2)	32 (19.6)
Unemployed	44 (26.4)	38 (23.3)
Retired	3 (1.8)	2 (1.2)
Household employed	2 (1.2)	1 (0.6)
Other	1 (0.6)	3 (1.8)
BMI (kg/m²), mean (SD)	26.0 (4.6)	26.0 (4.6)	0.869
Weight (kg), mean (SD)	74.9 (15.7)	75.3 (15.4)	0.660
Height (cm), mean (SD)	169.1 (9.2)	170.8 (9.3)	0.414
Abdominal perimeter (cm), mean (SD)	87.3 (14.7)	86.8 (13.6)	0.683
Baseline HbA_1c (%), mean (SD)	7.1 (0.7)	7.0 (0.6)	0.317
HbA_1c <6.5% or <48 mmol/mol, n (%)	32 (19.2)	29 (17.8)	0.749
HbA_1c <7% or <53 mmol/mol, n (%)	68 (40.7)	66 (40.5)	0.966
CV >36%, % (n/N)	82.5 (52/63)	84.5 (60/71)	0.759
Glucose measurements/day, mean (SD)	3.9 (1.5)	3.8 (1.6)	0.406
Total cholesterol, mean (SD)	173.5 (27.0)	174.6 (29.4)	0.868
HDL, mean (SD)	63.9 (49.3)	59.7 (17.7)	0.692
LDL, mean (SD)	96.8 (22.9)	96.3 (25.4)	0.909
VLDL, Mean (SD)	14.1 (6.9)	19.6 (18.0)	0.895
Triglycerides, mean (SD)	78.0 (44.7)	90.8 (70.3)	0.422

Table 2

Outcomes concerning safety variables

		CC (n = 167)	IC (n = 163)	P
Mild hypoglycemia/week, mean (SD)	V1	3.0 (3.0)	2.1 (2.1)	<0.05^*
	V3	2.5 (2.4)	2.5 (2.2)	0.881
	Difference	−0.42	0.34	<0.05^*
Severe hypoglycemia/3 months, mean (SD)	V1	0.2 (0.7)	0.1 (0.4)	0.116
	V3	0.1 (0.4)	0.1 (0.4)	0.825
	Difference	−0.12	0.00	0.136
Hyperglycemic episodes/week, mean (SD)	V1	2.3 (2.1)	2.4 (2.9)	0.391
	V3	2.1 (2.2)	2.4 (2.4)	0.098
	Difference	−0.20	0.09	0.110
Ketoacidosis/3 months, mean (SD)	V1	0.01 (0.08)	0.0 (0.0)	0.329
	V3	0.0 (0.0)	0.0 (0.0)	—
	Difference	−0.01	0.00	0.328
Hospital admissions for glycemic decompensation	V1	0.01 (0.1)	0.0 (0.0)	0.329
	V3	0.0 (0.0)	0.01 (0.1)	0.312
	Difference	−0.01	0.01	0.158

Table 3

PROs for both cohorts

		CC (n = 167)	IC (n = 163)	P
Fear of hypoglycemia: FH-15 score ≥28 (%)	V1	54.6	40.8	<0.05^*
Fear of hypoglycemia: FH-15 score ≥28 (%)	V3	58.7	40.2	<0.05^*
Stress related to diabetes: DDS score ≥3 (%)	V1	32.9	27.6	0.276
Stress related to diabetes: DDS score ≥3 (%)	V3	29.9	24.5	0.256
HRQoL: DQoL score (satisfaction), mean (SD)	V1	67.8 (16.1)	72.0 (12.4)	<0.05^*
	V3	69.5 (16.3)	71.7 (14.8)	0.215
	Difference	1.72	−0.37	0.313
HRQoL: DQoL score (impact of treatment), mean (SD)	V1	75.1 (13.2)	78.7 (10.7)	<0.05^*
	V3	75.6 (12.4)	79.0 (10.9)	<0.05^*
	Difference	0.58	0.26	0.957