We performed a closed observational cohort study in a series of women affected by GDM, comparing a group followed in telemedicine and a group evaluated in presence. The study was performed in Ferrara (Italy) from February 2018 until August 2019.
62 consecutive women affected by gestational diabetes were randomly enrolled, into the "telemedicine group” or the "conventional group”. For the “conventional group’’ the clinical follow-up took place at the Complex Operative Unit of Territorial Diabetology of Ferrara, with outpatients visits every two or three weeks, until the end of the pregnancy. For the “telemedicine group” there was only one medical examination in presence on the enrolment day, also including an interview with a dietician. Most of the women delivered at Operative Unit of Gynecology and Obstetrics of the Sant ‘Anna University Hospital in Ferrara, following the established protocols.
Between the 24th and 28th gestational week the diagnosis of gestational diabetes was made using an oral load curve with 75 g of glucose (Oral Glucose Tolerance Test - OGTT), in adult women without pre-existing diabetes. The “telemedicine group” women were provided with a glucometer, to perform the daily four-point glycemic self-check (fasting and one hour after the three main meals), automatically transferred to a virtual cloud through an application downloaded on their smartphone. Every week the same diabetologist checked all “telemedicine group” women’s values on the telematic platform, verifying the achievement of the glycemic targets (fasting < 90 mg / dl, one hour after a meal < 130 mg / dl). In case of achievement of the targets, the diabetologist carried out one telemedicine visit per month; in case of persistent exceeding off the target values, he prescribed insulin therapy and the woman switched to a conventional follow-up.
Finally, in October 2020 women were contacted by telephone to answer the Questions and Responses to the Oxford Maternity Diabetes Treatment Satisfaction Questionnaire (OMDTSQ) by Hirst et al [12], modified ad hoc and translated into Italian language (Table 1).
Table 1
Questions and Answers to the modified-Oxford Maternity Diabetes Treatment Satisfaction Questionnaire (OMDTSQ) modified. The first nine questions were translated into Italian from the original OMDTSQ by Hirst et al [12], with quantitative answers to be assigned a score on a Likert-type scale (from + 3 to -3); the last four questions have qualitative answers, assigned by the authors.
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Strongly disagree
(–3)
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Disagree
(–2)
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Mildly
disagree (-1)
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Neutral (0)
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Mildly
agree (+ 1)
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Agree (+ 2)
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Strongly agree (+ 3)
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Women’s overall satisfaction with gestational diabetes care
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1. I am satisfied with my current treatment
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2. I am satisfied the treatment I am
receiving is the best for me
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3. I am satisfied with my understanding of diabetes
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Relationship with the diabetes clinical care team
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4. I feel my maternity diabetes team knows enough about my current level of diabetes control
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5. I feel I have a good relationship with my maternity diabetes team
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6. I am satisfied with my maternity diabetes team’s understanding of my diabetes
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Satisfaction with the Gestational Diabetes-health system
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7. I find the equipment I use to check my blood sugars is convenient
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8. I feel the equipment I use to check my blood sugars is reliable
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9. My blood sugar monitoring fits in with my lifestyle
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10. I believe the number of diabetic visits was
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Few
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Proper
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Too Many
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11. I performed daily blood glucose checks as advised
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Always
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Sometimes
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Almost Never
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Never
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12. Do you performed the postpartum OGTTa?
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Yes
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No
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13. FOR TELEMEDICINE GROUP ONLY Would you recommend telemedicine in the management of gestational diabetes to a relative or friend with gestational diabetes?
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Yes
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No
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aOGTT: Oral Glucose Tolerance Test
For each of the two groups, the following demographic variables were evaluated: age, parity, twin pregnancy, pre-pregnancy BMI (Body Mass Index), HbA1c (glycated hemoglobin) at diagnosis, gestational week at diagnosis of diabetes, native Italian language. The obstetric variables considered are weight gain at the end of pregnancy, disease of pregnancy (gestational hypertension, preeclampsia, IntraUterine Growth Restriction-IUGR, cholestasis), induction of labor and mode of induction (mechanical, prostaglandins, oxytocin and combined methods), time of delivery and mode of delivery (spontaneous delivery, caesarean section or vacuum extractor), postpartum blood loss, cases of shoulder dystocia.
The neonatal outcomes evaluated were birthweight, Large for Gestational Age (LGA) infants, macrosomal infants, hypoglycemia at birth, admission to Neonatal Intensive Care Unit (NICU), respiratory distress, hyperbilirubinemia and malformations.
As a secondary endpoint, the women satisfaction on diabetes care was investigated by telephone interview. In the first part of the survey, they had to assess their agreement with the nine statements of the OMDTSQ (on general satisfaction with diabetes care, on the perception the relationship with the diabetes team and satisfaction with the technology used) giving a score on a seven-point Likert-type scale: from + 3 (= strongly agree) to -3 (= strongly disagree). In the second part of the interview, they had to express a qualitative judgment on the number of visits performed, on their adherence to glycemic controls, on the performance of postpartum OGTT; finally, only the “telemedicine group” was asked if they would recommend this method to friends or relatives with gestational diabetes (Table 1).
The data relating to glycemic control were retrieved from the computer databases used by the diabetes service: by a virtual cloud for the telemedicine group and by the values recorded by the glucometer for the conventional group. The maternal and neonatal clinical data derive from the medical records of the deliveries that occurred at the study center. Only in two cases of the telemedicine group, the letters of discharge of the birth that took place elsewhere were recovered. The questionnaire was submitted to women contacted randomly by telephone, by the same investigator.
To avoid selection bias, the two groups were selected randomly. To overcome language comprehension problems, the questionnaire was always administered by the same operator. Furthermore, it was not possible to avoid the medical surveillance bias (intrinsic to the nature of our study) as the telemedicine group was always controlled by the same diabetologist, while the conventional group was controlled by several diabetologists. The sample was chosen arbitrarily of the size of 30 women for each group.
Statistical Analysis
The T test was used to compare the continuous variables of the two groups; for the analysis of the observed frequencies the Chi-square test was used and, for the analysis of the frequencies of smaller samples, the Fisher test. The questionnaire was evaluated by comparing the average of the scores obtained for each response between the two groups, using the Mann-Whitney test for independent samples. A P value < 0.05 was set to calculate the static significance, calculated by MedCalc Software Ltd.