Internet-based cognitive-behavioral therapy is effective in reducing depressive symptomatology in type 1 diabetes: results of a randomized controlled trial.

Objective: Depression in people with diabetes is associated with poorer health outcomes. Although web programs integrating cognitive-behavioral therapy with diabetes education have shown good results, no similar approach has been implemented in Spain. This aim of this study was to administer an Internet-based cognitive-behavioral therapy program (CBT) for the treatment of mild-moderate depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study) and evaluate the efficacy of this program. Research design and methods: A pre-post randomized controlled study was conducted. The sample comprised 65 people with type 1 diabetes and mild-moderate depressive symptoms: 35 treatment group (TG) and 30 control group (CG). The following effects of the nine-session program were analyzed: depression (Beck Depression Inventory Fast Screen, BDI-FS), metabolic variables (glycosilated hemoglobin, HbA1c), and other psychological variables including anxiety (State Trait Anxiety Inventory, STAI), fear of hypoglycemia (Fear of Hypoglycemia Questionnaire, FH-15), distress (Diabetes Distress Questionnaire (DDS), quality of life (Diabetes Quality of Life Questionnaire, DQOL),and treatment adherence (Diabetes Self-Care Inventory-Revised questionnaire, SCI-R). Results: At the end of the treatment program, only 28 people were evaluated (TG=8; CG=20). However, a significant reduction was found in both groups in BDI-FS and STAI-T scores, which was significantly greater in the TG. Significant improvements were also found in the TG in DQOL, FH-15, DDS and SCI-R scores. The percentage change in these variables was also statistically significant in the TG versus the CG. However, no significant results were found in HbA1c. Conclusions: The Internet-based cognitive-behavioral therapy program for the treatment of mild-moderate depressive symptomatology in people with type 1 diabetes (WEB_TDDI1 study) is effective in reducing depressive symptomatology in the sample that completed the study. Positive results are also produced in other variables associated with depression in this population such as diabetes-related distress, trait anxiety, fear of hypoglycemia, quality of life, and adherence to diabetes treatment. Although new studies would be necessary to support the results of this platform, the results obtained are positive and support the use of this platform as an appropriate treatment for this population. Clinical trial registration: ClinicalTrials.gov; identifier NCT03473704.

Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: The single-center INEOX randomized controlled trial.

AIMS: To compare efficacy and safety of degludec 100 IU/mL (Deg-100) and glargine 300 IU/mL (Gla-300) in adults with type 1 diabetes. METHODS: Open-label, single-center, randomized, parallel-group, 24-week trial in adults with type 1 diabetes, on basal-bolus insulin therapy, HbA1c ≤ 10%, using self-monitoring blood glucose. Participants were randomized 1:1 to a basal-bolus insulin regimen with Deg-100 (N = 129) or Gla-300 (N = 131). Primary efficacy endpoint: mean change in HbA1c from baseline to week-24. Main safety outcome: incidence rate of hypoglycemia during the study. Quality of life (DQOL) and satisfaction with diabetes treatment (DTSQ) were assessed. RESULTS: At week 24, after adjusting for baseline HbA1c, the decrease in HbA1c did not differ between groups: Deg-100 (-0.07 ± 0.7%) and Gla-300 (-0.16 ± 0.77%) (P = 0.320). There were no significant differences between groups in HbA1c, nocturnal hypoglycemia, severe hypoglycemia, DQOL, or DTSQ scores. The incidence rates of hypoglycemia < 3.9 mmol/L (Deg-100: 115.24 events/person-year vs Gla-300: 99.01 events/person-year, p < 0.001); and < 3.0 mmol/L (Deg-100: 41.17 events/person-year vs Gla-300: 34.29 events/person-year, p < 0.001) were different between groups. CONCLUSIONS: Deg-100 and Gla-300 have similar metabolic efficacy, incidence ratio of nocturnal and severe hypoglycemia, DQOL and DTSQ scores. Differences in the incidence rate of hypoglycemia < 3.9 mmol/L and < 3.0 mmol/L should be confirmed.

Internet-based Cognitive-behavioral therapy (CBT) for depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study): A randomized controlled trial protocol.

BACKGROUND: Professionals need adequate tools to help patients with diabetes and depression. Although web programs integrating cognitive-behavioral therapy with diabetes education have shown good results, no similar approach has been performed as yet in Spain. The objective is to develop an Internet-based program for the treatment of mild-moderate depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study) based on Cognitive-behavioral therapy (CBT) and assess its results. METHODS: A 2-arm randomized controlled trial will be conducted. Adults with type 1 diabetes and mild-moderate depressive symptoms will be screened to participate in the study and randomly assigned to either the treatment group (TG) that will use a Web-based application for a specific 9-week intervention in depression and type 1 diabetes or the control group (CG) that will be on the waiting list during that time. RESULTS: Data on the primary variable (depressive symptoms) and secondary variables (treatment-related distress, anxiety, fear of hypoglycemia, quality of life, treatment adherence, coping strategies and glycemic control) will be collected from the TG at the beginning/baseline, at the end of treatment and at 3, 6 and 12 months after treatment. The CG will be assessed at the beginning and at the end of the TG intervention. On completion of the program by the TG, the treatment will then be carried out in the CG. CONCLUSIONS: The new web application developed is expected to be effective for the treatment of mild-moderate depressive symptoms in adults with type 1 diabetes, reducing depressive symptoms and improving the rest of the analyzed variables. TRIAL REGISTRATION: Registry: NCT03473704 (March 21, 2018); ClinicalTrials.gov.

Development and Validation of the Depression Inventory for Type 1 Diabetes (DID-1).

People with type 1 diabetes (T1D) are more likely to have depression than the general population and their prognosis is worse. Unfortunately, the characteristics of persons with T1D lead to inadequate screening for depression in this population. To aid in the detection of depression in this population, this study was undertaken to develop a depressive symptoms assessment instrument specific to patients with T1D and to examine its psychometric properties. A total of 207 people with T1D participated in this study. The reliability of the new scale was assessed using Cronbach's alpha and the Spearman-Brown split-half coefficient. The Depression Inventory for type 1 Diabetes (DID-1), composed of 45 items on a Likert scale (1-7), shows high internal and temporal consistency, as well as adequate concurrent, convergent and discriminant validity. Factor analysis identified 7 factors (Symptoms of depression, Diminished interest, Hopelessness and dissatisfaction, Guilt, Fear, frustration and irritability, Defenselessness, and Interference in daily life) that explained 61.612% of the total variability. The cut-off score for diagnosis was set at 155 points. It was concluded that the DID-1 scale is a reliable, valid and useful tool for the assessment of depressive symptoms, eliminating the bias of other nonspecific diabetes scales.

Development and Preliminary Validation of a New Type 1 Diabetes Adjustment Scale (DAS-1).

BACKGROUND: This study focuses on the development and validation of a new Type 1 Diabetes Adjustment Scale (DAS-1). METHOD: A total of 204 participants aged 15-65 with type 1 diabetes completed the self-report measures of the DAS-1, which includes clinical and psychological variables. RESULTS: Robust confirmatory factor analysis detected a unidimensional structure of the item scores. The omega coefficient was 0.91 and test-retest reliability was 0.87. Classifying subjects as in a Positive or Negative mood state, ROC analysis yielded an optimal cut-off of 50 for the DAS-1 scores, with a clinical accuracy of AUC = 0.85. The DAS-1 demonstrated evidence of good reliability and acceptable construct validity. CONCLUSION: The DAS-1 demonstrated good clinical utility, good sensitivity and adequate specificity. Clinical and theoretical implications of these results are discussed.

Diabetes Summer Camp in children and adolescents with type 1 diabetes: Effects on well-being and quality of life / Campamento de verano en niños y adolescentes con diabetes tipo 1: efectos sobre el bienestar y la calidad de vida

OBJETIVE: The aim of this study was to examine the quality of life, anxiety and affectivity in children and adolescents with type 1 diabetes (T1D) and in their parents after participating in a diabetes summer camp. METHOD: A total of 20 children and adolescents with T1D, aged 8-14, and their parents participated. The study design was quasi-experimental longitudinal with an intra-subject factor with two measurements (pre/post), and an inter-group factor (child/parent). RESULTS: After attending camp, a significantly increased quality of life, demonstrated by the emotional well-being and self-esteem scores, was found in the children but not in the parents. Less negative affectivity and an improvement in positive affectivity was seen in the parents, but not in the children. Differences in anxiety were found in both the children and the parents. CONCLUSIONS: This research presents empirical evidence of the benefits of participation in a diabetes camp in both children and their parents

OBJETIVO: El objetivo de este estudio fue examinar la calidad de vida, la ansiedad y la afectividad en niños y adolescentes con diabetes mellitus tipo 1 (DM1), y en sus padres después de participar en un campamento de verano de diabetes. MÉTODO: Participaron un total de 20 niños y adolescentes con DM1 de 8 a 14 años, además de sus padres. El diseño del estudio fue longitudinal cuasi-experimental con un factor intra-sujeto con 2 mediciones (pre/post), y un factor intergrupo (niño/padre). RESULTADOS: Después de asistir al campamento se observa un aumento significativo en la calidad de vida, demostrado en las puntuaciones de bienestar emocional y autoestima en los niños. Los padres mostraron menos afectividad negativa y más positiva. Se encontraron diferencias en ansiedad en niños y sus padres. CONCLUSIONES: Se muestra evidencia empírica sobre los beneficios de un campamento de diabetes tanto en niños como en sus padres

Diabetes Summer Camp in children and adolescents with type 1 diabetes: Effects on well-being and quality of life.

OBJETIVE: The aim of this study was to examine the quality of life, anxiety and affectivity in children and adolescents with type 1 diabetes (T1D) and in their parents after participating in a diabetes summer camp. METHOD: A total of 20 children and adolescents with T1D, aged 8-14, and their parents participated. The study design was quasi-experimental longitudinal with an intra-subject factor with two measurements (pre/post), and an inter-group factor (child/parent). RESULTS: After attending camp, a significantly increased quality of life, demonstrated by the emotional well-being and self-esteem scores, was found in the children but not in the parents. Less negative affectivity and an improvement in positive affectivity was seen in the parents, but not in the children. Differences in anxiety were found in both the children and the parents. CONCLUSIONS: This research presents empirical evidence of the benefits of participation in a diabetes camp in both children and their parents.

Bolus Calculator Reduces Hypoglycemia in the Short Term and Fear of Hypoglycemia in the Long Term in Subjects with Type 1 Diabetes (CBMDI Study).

BACKGROUND: In a previous study we demonstrated improvement in metabolic control and reduction in hypoglycemia in people with type 1 diabetes on multiple daily injections, after having used a bolus calculator for 4 months. OBJECTIVE: To demonstrate whether (1) extending its use (2) or introducing it in the control group, previously subjected to treatment intensification, could further improve metabolic control and related psychological issues. METHODS: After the previous clinical trial, in which the subjects were randomized either to treatment with the calculator or to control group for 4 months, both groups used the calculator during an additional 4-month period. RESULTS: In the previous control group, after using the device, HbA1c did not improve (7.86% ± 0.87% vs. 8.01% ± 0.93%, P 0.215), although a significant decrease in postprandial hypoglycemia was observed (2.3 ± 2 vs. 1.1 ± 1.2/2 weeks, P 0.002). In the group in which the treatment was extended from 4 to 8 months, HbA1c did not improve either (7.61 ± 0.58 vs. 7.73 ± 0.65, P 0.209); however this group had a greater perceived treatment satisfaction (12.03 ± 4.26 vs. 13.71 ± 3.75, P 0.007) and a significant decrease in fear of hypoglycemia (28.24 ± 8.18 basal vs. 25.66 ± 8.02 at 8 months, P 0.026). CONCLUSIONS: The extension in the use of the calculator or its introduction in a previously intensified control group did not improve metabolic control, although it did confirm a decrease in hypoglycemic episodes in the short term, while the extension of its use to 8 months was associated with a reduction in fear of hypoglycemia and greater treatment satisfaction.

Identification of risk factors for suffering fear of hypoglycemia in type 1 Diabetes Mellitus patients.

Hypoglycemia is one of the main burdens for type I Diabetes Mellitus (DM I) patients. The consequences of hypoglycemia can be quite unpleasant due to the variety of disagreeable physical and psychological symptoms it triggers. The patient's previous experience with hypoglycemia episodes will condition his psychological reaction to future episodes, promoting behavioral modifications that associate with poor glycemic control and worse prognosis, and even with developing psychological disorders, leading to fear of hypoglycemia (FH). To be able to provide tailored prevention and treatment of patients with FH it is necessary to identify the risk factors in DM I patients. We developed and validated the FH-15 scale, a novel instrument to assess FH, which showed good concurrent and predictive validity in DM I patients. In this work we aim to identify the risk factors for suffering FH by detecting DM I patients with FH using the FH-15 scale and then analyzing the association of clinical and sociodemographic variables. We found that age, needing help to resolve an episode of hypoglycemia, and a perceived lack of social support are risk factors for suffering FH.

Luminescent iminophosphorane gold, palladium and platinum complexes as potential anticancer agents.

A series of coordination gold(III), palladium(II), and platinum(II) complexes with a luminescent iminophosphorane ligand derived from 8-aminoquinoline [Ph3P=N-C9H6N] (1), have been synthesized and structurally characterized. The coordination palladium(II) and platinum(II) compounds can evolve further, under appropriate conditions, to give stable cyclometalated endo species [M{κ3-C,N,N-C6H4(PPh2=N-8-C9H6N}Cl] (M = Pd, Pt) by C-H activation of the phenyl group of the PPh 3 fragment. Iminophosphorane 1 and the new metallic complexes are luminescent in DMSO or DMSO:H2O (1:1 mixture) solutions at RT. The compounds have been evaluated for their antiproliferative properties in a human ovarian cancer cell line (A2780S), in human lung cancer cells (A-549) and in a non-tumorigenic human embryonic kidney cell line (HEK-293T). Most compounds have been more toxic to the ovarian cancer cell line than to the non-tumorigenic cell line. The new complexes interact with human serum albumin (HSA) faster than cisplatin. Studies of the interactions of the compounds with DNA indicate that, in some cases, they exert anticancer effects in vitro based on different mechanisms of action with respect to cisplatin.

Potential anticancer heterometallic Fe-Au and Fe-Pd agents: initial mechanistic insights.

A series of gold(III) and palladium(II) heterometallic complexes with new iminophosphorane ligands derived from ferrocenylphosphanes [{Cp-P(Ph2)═N-Ph}2Fe] (1), [{Cp-P(Ph2)═N-CH2-2-NC5H4}2Fe] (2), and [{Cp-P(Ph2)═N-CH2-2-NC5H4}Fe(Cp)] (3) have been synthesized and structurally characterized. Ligands 2 and 3 afford stable coordination complexes [AuCl2(3)]ClO4, [{AuCl2}2(2)](ClO4)2, [PdCl2(3)], and [{PdCl2}2(2)]. The complexes have been evaluated for their antiproliferative properties in human ovarian cancer cells sensitive and resistant to cisplatin (A2780S/R), in human breast cancer cells (MCF7) and in a nontumorigenic human embryonic kidney cell line (HEK-293T). The highly cytotoxic trimetallic derivatives M2Fe (M = Au, Pd) are more cytotoxic to cancer cells than their corresponding monometallic fragments. Moreover, these complexes were significantly more cytotoxic than cisplatin in the resistant A2780R and the MCF7 cell lines. Studies of the interactions of the trimetallic compounds with DNA and the zinc-finger protein PARP-1 indicate that they exert anticancer effects in vitro based on different mechanisms of actions with respect to cisplatin.

Infant neurocognitive development is independent of the use of iodised salt or iodine supplements given during pregnancy.

The benefits of iodine supplements during pregnancy remain controversial in areas with a mild-to-moderate iodine deficiency. The aim of the present study was to determine the effect of improving iodine intakes, with iodised salt (IS) or iodine supplements, in pregnant Spanish women. A total of 131 pregnant women in their first trimester were randomly assigned to three groups: (1) IS in cooking and at the table, (2) 200 µg potassium iodide (KI)/d or (3) 300 µg KI/d. No differences were found in thyroid-stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3) or thyroid volume (TV) between the three groups. Regardless of the group in which women were included, those who had been taking IS for at least 1 year before becoming pregnant had a significantly lower TV in the third trimester (P= 0.01) and a significantly higher urinary iodine in the first (173.7 (sd 81.8) v. 113.8 (sd 79.6) µg/l, P= 0.001) and third trimesters (206.3 (sd 91.2) v. 160.4 (sd 87.7) µg/l, P= 0.03). Also, no differences were seen in TSH, FT4 or FT3. Children's neurological development was not significantly associated with the consumption of IS for at least 1 year before becoming pregnant and no differences were found according to the treatment group. In conclusion, in pregnant women with insufficient iodine intake, the intake of IS before becoming pregnant was associated with a better maternal thyroid function. The form of iodide intake was not associated with maternal thyroid function or children's neurological development.

Organometallic Palladium Complexes with a Water-Soluble Iminophosphorane Ligand as Potential Anticancer Agents.

The synthesis and characterization of a new water-soluble iminophosphorane ligand TPA=N-C(O)-2BrC(6)H(4) (C,N-IM; TPA = 1,3,5-triaza-7-phosphaadamantane) 1 is reported. Oxidative addition of 1 to Pd(2)(dba)(3) affords the orthopalladated dimer [Pd(µ-Br){C(6)H(4)(C(O)N=TPA-kC,N)-2}](2) (2) as a mixture of cis and trans isomers (1:1 molar ratio) where the iminophosphorane moeity behaves as a C,N-pincer ligand. By addition of different neutral or monoanionic ligands to 2, the bridging bromide can be cleaved and a variety of hydrophilic or water-soluble mononuclear organometallic palladium(II) complexes of the type [Pd{C(6)H(4)(C(O)N=TPA-kC,N)-2}(L-L)] (L-L = acac (3); S(2)CNMe(2) (4); 4,7-Diphenyl-1,10-phenanthrolinedisulfonic acid disodium salt C(12)H(6)N(2)(C(6)H(4)SO(3)Na)(2) (5)); [Pd{C(6)H(4)(C(O)N=TPA-kC,N)-2}(L)Br] (L = P(mC(6)H(4)SO(3)Na)(3) (6); P(3-Pyridyl)(3) (7)) and, [Pd(C(6)H(4)(C(O)N=TPA)-2}(TPA)(2)Br] (8) are obtained as single isomers. All new complexes were tested as potential anticancer agents and their cytotoxicity properties were evaluated in vitro against human Jurkat-T acute lymphoblastic leukemia cells, normal T-lymphocytes (PBMC) and DU-145 human prostate cancer cells. Compounds [Pd(µ-Br){C(6)H(4)(C(O)N=TPA-kC,N)-2}](2) (2) and [Pd{C(6)H(4)(C(O)N=TPA-kC,N)-2}(acac)] 3 (which has been crystallographically characterized) display the higher cytotoxicity against the above mentioned cancer cell lines while being less toxic to normal T-lymphocytes (peripheral blood mononuclear cells: PBMC). In addition, 3 is very toxic to cisplatin resistant Jurkat shBak indicating a cell death pathway that may be different to that of cisplatin. The interaction of 2 and 3 with plasmid (pBR322) DNA is much weaker than that of cisplatin pointing to an alternative biomolecular target for these cytotoxic compounds. All the compounds show an interaction with human serum albumin (HSA) faster than that of cisplatin.

Cytotoxic hydrophilic iminophosphorane coordination compounds of d8 metals. Studies of their interactions with DNA and HSA.

The synthesis and characterization of a new water-soluble N,N-chelating iminophosphorane ligand TPAN-C(O)-2-NC(5)H(4) (N,N-IM) (1) and its d(8) (Au(III), Pd(II) and Pt(II)) coordination complexes are reported. The structures of cationic [AuCl(2)(N,N-IM)]ClO(4) (2) and neutral [MCl(2)(N,N-IM)] M=Pd (3), Pt(4) complexes were determined by X-ray diffraction studies or by means of density-functional calculations. While the Pd and Pt compounds are stable in mixtures of DMSO/H(2)O over 4 days, the gold derivative (2) decomposes quickly to TPAO and previously reported neutral gold(III) compound [AuCl(2)(N,N-H)] 5 (containing the chelating N,N-fragment HN-C(O)-2-NC(5)H(4)). The cytotoxicities of complexes 2-5 were evaluated in vitro against human Jurkat-T acute lymphoblastic leukemia cells and DU-145 human prostate cancer cells. Pt (4) and Au compounds (2 and 5) are more cytotoxic than cisplatin to these cell lines and to cisplatin-resistant Jurkat sh-Bak cell lines and their cell death mechanism is different from that of cisplatin. All the compounds show higher toxicity against leukemia cells when compared to normal human T-lymphocytes (PBMC). The interaction of the Pd and Pt compounds with calf thymus and plasmid (pBR322) DNA is different from that of cisplatin. All compounds bind to human serum albumin (HSA) faster than cisplatin (measured by fluorescence spectroscopy). Weak and stronger binding interactions were found for the Pd (3) and Pt (4) derivatives by isothermal titration calorimetry. Importantly, for the Pt (4) compounds the binding to HSA was reversed by addition of a chelating agent (citric acid) and by a decrease in pH.

Use of telemedicine in subjects with type 1 diabetes equipped with an insulin pump and real-time continuous glucose monitoring.

We evaluated a telemedicine system in patients with type 1 diabetes who had optimized treatment with an insulin pump and a real-time continuous glucose monitoring system. We conducted a prospective, one-year study of 15 subjects. Three medical visits took place: pre-baseline, baseline and at 6 months. Each month the subjects transmitted information from the glucose meter, glucose sensor and insulin pump. We adjusted the treatment and returned the information by email. We evaluated psychological and metabolic variables, including HbA(1c), hypoglycaemia, hyperglycaemia and glucose variability. At baseline the mean age of the subjects was 40 years and the mean duration of diabetes was 22 years. There was a significant reduction in HbA(1c) (7.50 to 6.97%) at 6 months, a significant increase in the number of self-monitoring blood glucose checks per day (5.2 to 6.2), and significant improvements in variability: MODD, mean of daily difference (67 to 53) and MAGE, mean amplitude of glycaemic excursions (136 to 102). There were significant improvements in quality of life (92 to 87), satisfaction with the treatment (34 to 32) and less fear of hypoglycaemia (36 to 32). Adult subjects with type 1 diabetes on treatment with a continuous insulin infusion system and a real time glucose sensor and who have acceptable metabolic control and optimized treatment can benefit from the addition of a telemetry system to their usual outpatient follow-up.

Fluorous hydrosilylation.

In this review, we describe the papers and patents dealing with the fluorous biphasic system (FBS) hydrosilylation reactions reported to date. Despite the limited number of reports, the FBS hydrosilylation reaction has been extremely successful. In all cases fluorous monophosphines (either alkylic or perfluoroalkylsilyl-substituted derivatives of triphenylphosphine) have been employed as ligands to synthesize and inmobilize the metal catalysts (either rhodium(I) or gold(I) derivatives) in the fluorous solvent (including a fluorous ionic liquid). The hydrosilylation of alkenes, ketones and enones with fluorous rhodium analogs to the Wilkinson's catalyst [RhCl(PPh(3))(3)], have afforded high TON/TOF and a very efficient separation and recycling of the fluorous catalyst. Modification of the fluorous content and position of the fluorous tails in the aryl groups of the phosphines have allowed for further optimization of the process and a better recovery of the catalyst with minimal leaching of rhodium and fluorous ligand to the organic phase. Moreover, the use of the so-called second generation methods which eliminate the need of fluorous solvents by exploiting the temperature-dependent solubilities of fluorous catalysts in common organic solvents (thermomorphic properties) have permitted the use and separation of fluorous alkyl-phosphine rhodium catalysts in hydrosilylation reactions in conventional organic solvents. The addition of an insoluble fluorous support such as Teflon tape allowed for an exceptionally easy and efficient recovery of fluorous rhodium catalysts ("catalyst-on-a-tape") in the hydrosilylation of ketones. In the case of the FBS gold-catalyzed hydrosilylation of aldehydes, new fluorous gold catalysts with alkylic phosphines have led to an efficient separation and recycling of the gold catalysts although the TON/TOF are lower than in the rhodium-catalyzed hydrosilylation of alkenes and ketones. A detailed study of the non-fluorous gold-catalyzed version has helped to explain how this catalytic system could be improved.

Development of a new fear of hypoglycemia scale: FH-15.

Hypoglycemia is the most common adverse event associated with insulin treatment in diabetes. The consequences of hypoglycemia can be quite aversive and potentially life threatening. The physical sequelae provide ample reason for patients to fear hypoglycemia and avoid episodes. For these reasons, our purpose in this study was to develop a new measure that explores specific fear of hypoglycemia (FH) in adult patients with type 1 diabetes and to examine its psychometric properties. The instrument developed to assess FH was initially made up of 20 items, of which 18 were negative and 2 were positive, assessed on a 5-point Likert scale (1-5). This scale was completed by 229 patients with type 1 diabetes. Additionally, a structured interview and a closed question called subjective fear of hypoglycemia were included as diagnostic criteria. A factor analysis employing the principal-components method and promax rotation was carried out, resulting in a new scale composed of 15 items. Three factors (fear, avoidance, and interference) were obtained and explained 58.27% of the variance. The scale showed good internal consistency (Cronbach's α = .891) and test-retest reliability (r = .908, p < .001), as well as adequate concurrent and predictive validity. The cutoff score that provided the highest overall sensitivity and specificity was set at 28 points. The Fear of Hypoglycemia 15-item scale (FH-15) demonstrated good reliability and validity. This study suggests that the new instrument may serve as a valuable measure of specific FH for use in research and clinical practice.

Depresión en la diabetes mellitus tipo 1 y factores asociados / Depression in type 1 diabetes mellitus and associated factors

Fundamento y objetivo: En los últimos años ha aumentado el interés por la depresión y los factores de riesgo en diabetes. Objetivos: 1) estudiar las variables asociadas a la presencia de depresión en pacientes con diabetes mellitus tipo 1 (DM1); 2) analizar posibles factores de riesgo de depresión en estos pacientes; 3) determinar un posible modelo explicativo de las puntuaciones de depresión en este tipo de pacientes. Pacientes y método: Doscientos siete pacientes con DM tipo 1. Las variables sociodemográficas y biomédicas fueron evaluadas mediante entrevista estructurada y las variables psicológicas mediante la Escala de Depresión en Diabetes Tipo 1 (EDDI-1) y la Versión española del Diabetes Quality of Life (Es DQOL). Resultados: La prevalencia de depresión fue del 21,7%. Variables asociadas con riesgo de depresión en la muestra estudiada: ser mujer; no estar empleado; fumador; tener complicaciones por la diabetes u otra afección física; no percibir apoyo de la familia, amigos ni compañeros de trabajo en relación a la diabetes; número elevado de hiperglucemias semanales; y baja calidad de vida. Se ha obtenido un modelo, basado en investigaciones previas, que explica un alto porcentaje de la variabilidad en las puntuaciones de los pacientes en la Escala de Depresión en Diabetes Tipo 1.Conclusiones: Estos resultados proporcionan apoyo empírico sobre los factores de riesgo asociados a la depresión en pacientes con DM tipo1. Las variables control glucémico y calidad de vida han tenido un peso importante en las puntuaciones de la Escala de Depresión en Diabetes Tipo 1, lo que aporta una valiosa información para la planificación del tratamiento de estos pacientes (AU)

Background and objective: In recent years, there has been an increased interest in depression and diabetes risk factors. Our objectives were 1) Study the variables associated with the presence of depression in patients with type 1 diabetes mellitus (DM1), 2) to analyze potential risk factors for depression in these patients, and 3) to study a possible explanatory model of depression scores in these patients.Patients and methods: 207 patients with DM1. We evaluated sociodemographic and biomedical variables by means of a structured interview. We assessed psychological variables by means of the Scale for Depression in Type 1 Diabetes (EDDI-1) and the Spanish version of Diabetes Quality of Life (Es DQOL).Results: Prevalence of depression was 21,7%. Variables associated with risk of depression in this sample were to be female; be unemployed; smoking; having complications of diabetes or other physical conditions; not perceiving family support or support from friends or colleagues in relation to diabetes; having a high number of weekly hyperglycemia; and a poor quality of life. A model based on previous research was obtained. This model explains a high percentage of the variability in the scores of patients in the EDDI-1. Conclusions: These results provide an empirical support to the knowledge of the risk factors associated with depression in patients with DM1. Glycemic control and quality of life have an important effect on the scores of depression in these patients, providing information for their treatment (AU)

[Depression in type 1 diabetes mellitus and associated factors]. / Depresión en la diabetes mellitus tipo 1 y factores asociados.

BACKGROUND AND OBJECTIVE: In recent years, there has been an increased interest in depression and diabetes risk factors. Our objectives were 1) Study the variables associated with the presence of depression in patients with type 1 diabetes mellitus (DM1), 2) to analyze potential risk factors for depression in these patients, and 3) to study a possible explanatory model of depression scores in these patients. PATIENTS AND METHODS: 207 patients with DM1. We evaluated sociodemographic and biomedical variables by means of a structured interview. We assessed psychological variables by means of the Scale for Depression in Type 1 Diabetes (EDDI-1) and the Spanish version of Diabetes Quality of Life (Es DQOL). RESULTS: Prevalence of depression was 21,7%. Variables associated with risk of depression in this sample were to be female; be unemployed; smoking; having complications of diabetes or other physical conditions; not perceiving family support or support from friends or colleagues in relation to diabetes; having a high number of weekly hyperglycemia; and a poor quality of life. A model based on previous research was obtained. This model explains a high percentage of the variability in the scores of patients in the EDDI-1. CONCLUSIONS: These results provide an empirical support to the knowledge of the risk factors associated with depression in patients with DM1. Glycemic control and quality of life have an important effect on the scores of depression in these patients, providing information for their treatment.