Glycemic variability in diagnosis of gestational diabetes as predictor of pharmacological treatment.

INTRODUCTION: To establish whether glycemic variability (GV) parameters used when gestational diabetes mellitus (GDM) has been diagnosed could help predict the probability that a patient will need pharmacological treatment, and to analyze the link of these parameters to the development of maternal-fetal complications. MATERIALS AND METHODS: A prospective study of 87 women with GDM who underwent retrospective continuous glucose monitoring (CGM) for six days between weeks 26 and 32 of gestation, following diagnosis. The mean glycemia levels and GV variables were analyzed together with their link to maternal-fetal complications, and the need for pharmacological treatment. ROC (receiver operating characteristic) curves were developed to determine validity to detect the need for pharmacological treatment. RESULTS: Patients with higher mean glycemia (p < 0.001) and continuous overlapping of net glycemic action in a period of n-hours (CONGAn) (p = 0.001) required pharmacological treatment. The ROC curves showed cut-off points of 98.81 mg/dL for mean glycemia, and 86.70 mg/dL for CONGAn, with 83.3% sensitivity and 67.8% specificity for both parameters. No relation between the GV parameters and development of maternal-fetal complications was observed. CONCLUSIONS: The use of CGM, once GDM is diagnosed, enables us to identify those patients who would benefit from closer monitoring during gestation, and facilitate a speedier take-up of pharmacological treatment. However, prospective studies involving a higher number of patients are needed, as well as a cost assessment for recommending the use of CGM following GDM diagnosis.

Continuous Glucose Monitoring and Glycemic Patterns in Pregnant Women with Gestational Diabetes Mellitus.

Background: Continuous glucose monitoring (CGM) could detect certain patterns of hyperglycemia at different times of the day that may help predict the development of maternal-fetal complications and the probability of needing pharmacological treatment. Methods: This study prospectively examined 77 women with gestational diabetes mellitus (GDM) who were placed on a CGM system for 6 days after diagnosis between 26 and 32 weeks of gestation. Patterns of hyperglycemia before meals (period of time of an hour just before meal) (>95 mg/dL), after meals (time interval of 2 h and half just after meal) (>140 mg/dL), and overnight (0-7 am) (>120 mg/dL) and their association with maternal-fetal complications and pharmacological treatment were analyzed. Receiver operating characteristic curves were developed to estimate the validity of the various patterns in detecting the need for pharmacological treatment. Results: A statistically significant relationship was observed between time in hyperglycemia after lunch and macrosomia (P = 0.035) and large for gestational age infants (P = 0.010). Pharmacological treatment was required for patients with time above range (TAR; P = 0.006) and those with hyperglycemia patterns before breakfast (P < 0.001), after breakfast (P = 0.006), before dinner (P = 0.012), and overnight (P = 0.001). Every additional percentage point of TAR was associated with a 24% increase in the probability of pharmacological treatment. Conclusions: The use of CGM for the diagnosis of GDM allows the identification of those patients who would benefit from closer monitoring during pregnancy, including self-monitoring of both pre- and postprandial blood glucose levels, facilitating the initiation of early pharmacological treatment.

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.

OBJECTIVE: To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction. RESULTS: At month 6, the mean change in HbA1c levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05). CONCLUSIONS: The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.

Efectividad y seguridad de un modelo protocolizado de control glucémico en el medio hospitalario / Effectiveness and safety of a blood glucose control protocol in hospital

OBJETIVO: Evaluar la efectividad y seguridad de un protocolo de control glucémico para pacientes con diabetes mellitus (DM) en el medio hospitalario. MATERIAL Y MÉTODOS: Estudio de intervención, prospectivo y abierto realizado en pacientes con DM ingresados en planta de hospitalización convencional. Los pacientes fueron asignados a un grupo de intervención (protocolo de control glucémico), o a un grupo control (tratamiento para la diabetes según práctica habitual) con evaluaciones cada 48 h, estableciéndose como objetivo primario la obtención de glucemias preprandiales entre 80 y 180mg/dl, siendo el objetivo secundario la ausencia de hipoglucemias. RESULTADOS: Se incluyó a 104 pacientes de 67,8±9,2 años de edad, 13,7±10,2 años de evolución de diabetes y HbA1c media de 7,8±1,5%. En el grupo de intervención se observó una mejoría significativa en las glucemias capilares antes del desayuno, almuerzo, cena y media de 24 h tanto con respecto al día 0 como comparativamente con el grupo control, alcanzando el 7.° día de seguimiento una glucemia media de 148,2±30,3mg/dl. El porcentaje de pacientes con glucemia entre 80 y 180mg/dl superó el 50% desde el día 4 para la glucemia en ayunas, desde el día 5 para la glucemia antes del almuerzo y desde el día 7 para la glucemia antes de la cena. Siete pacientes (13,4%) presentaron hipoglucemias leves en el grupo de intervención y 9 (17,3%) en el grupo control (p = 0,817). CONCLUSIONES: La aplicación de un protocolo de control glucémico en el medio hospitalario es efectiva para mejorar el control metabólico y alcanzar los objetivos establecidos, con un bajo número de hipoglucemias asociadas

OBJECTIVE: To evaluate the effectiveness and safety of a glucose control protocol designed to manage patients with diabetes in hospital. MATERIAL AND METHODS: An interventional, prospective and open study was designed for patients with diabetes admitted in a conventional hospital setting. Patients were randomized to an intervention group (glucose control protocol) or to a control group (conventional treatment for diabetes). Blood glucose was performed every 48 hours. The primary endpoint was to obtain a pre-prandial blood glucose between 80 and 180 mg/dl, and the secondary endpoint was the absence of hypoglycemia. RESULTS: The study included a total of 104 patients (51.0% male), with a mean age of 67.8 ± 9.2 years old, 13.7 ± 10.2 years since onset of diabetes, and mean HbA1c of 7.8±1.5%. The patients in the intervention group showed a significant improvement in glucose control before all meals as well as in the 24 hour mean compared to day 0 and with the control group. In the first week, patients achieved a mean blood glucose of 148.2 ± 30.3 mg/dl. The percentage of patients with blood glucose between 80 and 180mg/dl gradually increased, exceeding 50% of patients from day 4 for fasting blood glucose, day 5 for blood glucose before lunch, and day 7 for blood glucose before dinner. Seven patients (13.4%) had mild hypoglycemia in the intervention group, and nine (17.3%) in the control group (P = 0.817). CONCLUSIONS: The use of a blood glucose control protocol in hospital settings is effective for improving metabolic control and to achieve the targets, with a low rate of associated hypoglycemia