Metabolic Benefit of Teleconsultation for Diabetes Management During the COVID-19 Pandemic: A French Observational Prospective Study
Introduction
The COVID-19 pandemic has been a major health crisis in France over the past several years, forcing patients and health care professionals to modify their approach to chronic disease management. Diabetes, promptly considered a medical condition at risk of developing a severe SARS-CoV-2 infection,1 has been subjected to particular attention, concerning daily glycemic monitoring.2,3 Increased COVID-19-related mortality was associated not only with cardiovascular and renal diabetic complications but also, independently, with glycemic control and body mass index (BMI).4,5
Numerous studies have documented the utility of telemedicine in diabetes care to improve both metabolic control and caregivers’ and patients’ satisfaction.6–8 Given this context, the reorganization of the diabetology units and management of outpatients with diabetes able to benefit from telemedicine solutions like teleconsultation or telemonitoring allowed for good-quality diabetes care. Initial lockdown orders at the COVID-19 pandemic onset in March 2020 abruptly limited in-person health service delivery across the health system, creating the opportunity for caregiver to applying telemedicine for their patients with diabetes.9
Given this pandemic context, we aimed to (1) compare glycemic control between diabetic patients having benefited and those having not benefitted from teleconsultation and (2) analyze the frequency of death and hospitalization cases during the 6-month follow-up in both groups.
Patients and Methods
STUDY DESIGN
We conducted an observational prospective study in the endocrinology, diabetes and nutrition department of Strasbourg University and a private diabetology practice in Strasbourg (ClinicalTrial.gov Identifier: N-NCT04370171). The protocol was approved by the Committee for the Protection of Persons (ID-RCB: 2020-A00974-35). For each patient, the nonopposition to participating in the study was verified orally by telephone.
PATIENTS AND METHODS
All patients with diabetes aged >18 years requiring a face-to-face consultation were consecutively included in the study. Pregnant women, patients with cancer, those whose life expectancy was limited to 6 months, and those with acute complications, including stroke, myocardial infarction, or foot wounds, were excluded from participation.
All patients were contacted by phone to replace face-to-face consultation by teleconsultation. In the telemedicine group, patients benefited from a teleconsultation by videoconference or phone to replace the face-to-face consultation scheduled the same day. The teleconsultation modalities were as follows: administrative patient registration into a secure site, transfer of biological or continuous glucose monitoring data, consultation summery recorded in the patient file, sending of biological and medication prescriptions, letter to the medical correspondent, and next consultation date. The group “without teleconsultation” was composed of patients who refused teleconsultation or for whom face-to-face consultation was delayed due to unavailability of medical doctor. Three months later, the patients received a prescription for glycated hemoglobin (HbA1c) measurement. All patients benefited from a face-to-face consultation 6 months following the teleconsultation or postponed consultation dates.
Patient characteristics were collected from computerized medical records of Strasbourg University (DxCare® software; Medasys, Le Plessis-Robinson, France) and from the Crossway® software (Cegedim, Boulogne-Billancourt, France) for the liberal diabetology practice.
PRIMARY ENDPOINT
The primary endpoint was HbA1c at 6 months following the study start in the two “with teleconsultation or T+” and “without teleconsultation or T−” Groups.
SECONDARY ENDPOINTS
The secondary endpoints included HbA1c at 3 months, BMI, insulin requirements, change in diabetes treatment at 6 months, acute complications, number of SARS-CoV-2 infected cases, death cases, and number of patients accessible for videoconferencing and telephone calls in hospital and private diabetology practice.
STATISTICAL ANALYSIS
Baseline characteristics were reported as frequencies and percentages for categorical variables and as mean ± standard deviation. Mean ± standard error values of HbA1c in Teleconsultation présent (TC+) versus No Teleconsultation (TC−) Groups were provided graphically. Statistical analysis was performed using Wilcoxon matched-pairs signed-rank test. Mixed models for repeated measures were analyzed for comparing changes from baseline at 6 months. A 95% confidence interval (CI) for treatment differences in the change from baseline was calculated. A p-value <0.05 was considered statistically significant.
Results
POPULATION CHARACTERISTICS
From March 17 to May 31, 2020, 610 patients were included in the study, 456 of whom were followed-up using teleconsultation, resulting in 456 pertaining to the TC+ Group and 154 to the TC− Group. Patients in TC+ Group were younger, 57 ± 17 versus 65 ± 15.5 years (p < 0.001) and displayed a lower BMI, 28 ± 6.2 kg/m2 versus 30 ± 5.8 kg/m2, versus those in TC− Group (p < 0.001). Overall, 52% of patients from TC+ Group exhibited type 1 diabetes versus 45% of those from TC− Group (p < 0.001), with 14% of secondary diabetes in TC+ versus 6% in TC− Groups (p < 0.01). HbA1c levels were comparable between the TC+ and TC− Groups: 7.35 ± 0.27% versus 7.48 ± 0.22% (p = 0.7), respectively, with no difference in terms of diabetes complications.
Overall, 62% of TC+ versus 50% of TC− Group patients underwent hospital follow-up. The COVID-19 infection rate defined by either symptom presence or positive screening test was comparable between both groups: 1.9% versus 1.5%. In TC+ Group, 63% of consultations were carried via phone and 37% via videoconferencing. Concerning patients followed-up in hospital, 7% of teleconsultations were realized by video versus 44% of those undergoing private practice follow-up (Table 1).
| PATIENTS | TOTAL POPULATION | GROUP, TC+ | GROUP, TC− | p |
|---|---|---|---|---|
| N | 610 | 456 | 154 | — |
| Men/women, n | 336/274 | 250/206 | 86/68 | 0.8 |
| Age (years) | 59 ± 17 | 57 ± 17 | 65 ± 15.5 | <0.001 |
| BMI (kg/m2) | 28.6 ± 6.2 | 28 ± 6.2 | 30 ± 5.8 | <0.001 |
| Type of diabetes: n (%) | ||||
| T1D | 245 (40) | 238 (52) | 69 (45) | <0.001 |
| T2D | 292 (48) | 154 (34) | 76 (49) | 0.01 |
| Other | 73 (12) | 64 (14) | 9 (6) | <0.01 |
| HbA1c (%) | 7.37 ± 1.32 | 7.35 ± 1.28 | 7.45 ± 1.44 | 0.8 |
| Treatment, n (%) | ||||
| Oral agent | 232 (39) | 184 (44) | 45 (29) | <0.5 |
| GLP1 analogue | 130 (22) | 75 (18) | 54 (35) | <0.001 |
| Insulin | 422 (71) | 330 (76) | 92 (68) | 0.4 |
| Insulin dose (IU) | 45.3 ± 31 | 45.5 ± 31.5 | 44.1 ± 28.6 | 0.9 |
| MDI/insulin pump (n) | 241/156 | 178/133 | 65/30 | 0.1/<0.5 |
| Complications, n (%) | ||||
| Microangiopathy | 267 (47) | 189 (47) | 78 (51) | <0.5 |
| Macroangiopathy | 157 (28) | 117 (29) | 41 (27) | 0.8 |
| Hospital follow-up, n (%) | 360 (59) | 283 (62) | 77 (50) | — |
| Private practice follow-up, n (%) | 250 (41) | 173 (38) | 77 (50) | — |
| COVID-19 infection (symptoms and/or positive screening test), n (%) | 10 (1.8) | 8 (1.9) | 2 (1.5) | 0.7 |
METABOLIC EVALUATION
At 6-month follow-up, HbA1c was significantly lower in TC+ compared to TC− Groups: 7.21 ± 0.15% versus 7.6 ± 0.18% (p = 0.004). HbA1c did not significantly differ between both groups at 3 months: 7.13 ± 0.15 versus 7.35 ± 0.17 (p = 0.06) (Fig. 1). BMI remained lower in TC+ compared to TC− Group patients: 27.8 ± 6.4 kg/m2 versus 29.9 ± 5.7 kg/m2 (p < 0.001) without any modified insulin requirements. Therapeutic modifications were significantly increased in TC+ versus TC− Groups: odds ratio = 6.9 (95% CI 2.4–20), p < 0.001.
Fig. 1. HbA1c evolution in TC+ (– –) and TC− Groups (—) Data shown are mean ± standard error of mean. **p < 0.01. HbA1c, glycated hemoglobin; TC+, Teleconsultation présent; TC−, No Teleconsultation.
DEATH, HOSPITALIZATIONS, AND COVID-19 INFECTION
During the 6-month follow-up, two patients from TC+ died, one due to COVID-19 infection, and the second from cystic fibrosis-related respiratory complications; in TC− Group, one patient died from liver cancer.
Overall, 35 hospitalizations (7.8%) were recorded in TC+ during follow-up, the main reasons of hospitalization were hyperglycemia and ketoacidosis (n = 4), acute macrovascular complications (n = 6), digestive disorders (n = 6), cancer complications (n = 3), renal failure (n = 3), severe hypoglycemia (n = 1) and other causes. In TC−, 21 (13.6%) hospitalizations were documented, including COVID-19 infection (n = 2), acute macrovascular complications (n = 3), hyperglycemia (n = 2), pulmonary and urinary infection (n = 3), severe hypoglycemia (n = 1), and others causes. COVID-19 infection not requiring hospitalization occurred in 14 TC+ (3%) and four TC− (2.6%) Group patients.
Discussion
We have reported on a large observational study designed to assess the impact of teleconsultation on diabetes patients during the first lockdown in France, involving 610 diabetic subjects followed-up in either hospital or liberal environments.
In our study, the subjects who benefited from teleconsultation were significantly younger and less corpulent than those who did not. Moreover, those benefitting from teleconsultation more often exhibited type 1 diabetes or diabetes of an undetermined nature versus those who did not. This finding is in itself not surprising, given the technical conditions required to attend a teleconsultation, these conditions being usually prohibited for elderly subjects. We must note that 63% of teleconsultations were carried out by phone and 37% using videos. For patients undergoing hospital follow-up, 7% of teleconsultations were performed using videos versus 44% for those undergoing private practice follow-up. This is likely suggestive of different socioeconomical population characteristics. Conversely, initial HbA1c levels were not significantly different between the groups.
HbA1c analysis revealed a trend toward a greater decrease in HbA1c levels at 3 months in TC+ versus TC− Groups, although statistical significance was not reached. At 6 months, the decrease in HbA1c remained only in TC+ Group, whereas the HbA1c levels increased between 3- and 6-month follow-ups in the TC− Group, the between-group differences attaining statistical significance. While using a care self-administrated questionnaire, Ludwig et al. reported a significant 0.3% decrease in HbA1c in 870 diabetic subjects during the lockdown period at 6-month follow-up.10 In this single-center observational study, 32.1% resorted to teleconsultation.
However, this subgroup was not compared to patients who did not benefit from a teleconsultation. In our study, we cannot exclude that modification of diabetes patient behavior during lockdown played a relevant role upon lockdown.11 A study involving patients with type 1 diabetes from another French region reported an improvement in glycemic control, which was explained, at least to some extent, by an improved diabetes control perception.12
Weight changes were observed between both groups, with a significantly lower weight after 6 months in TC+ patients. More frequent therapeutic modifications recorded in this group likely contributed to between-group differences in HbA1c levels. Contrasting results were found by Ludwig et al., with 32% of subjects undergoing weight gains and 16% weight losses during lockdown.10 However, a statistical analysis that considered whether or not patients underwent teleconsultation was not performed in this study. The decrease in HbA1c levels in TC+ patients suggested an effective patient management for people with diabetes, whereas increases in HbA1c levels in those who did not undergo teleconsultation likely reflected the lockdown impact. In our study, no differences were found in deaths and SARS-CoV-2 infections, while 7.8% and 13.6% hospitalizations were reported in TC+ and TC− Groups.
Despite its large diabetic population, our study presents several weaknesses. The first one is its monocentric, uncontrolled design, which renders it difficult to extrapolate the data. The reasons leading to nonparticipation to teleconsultation, which was systematically offered to all patients, are multiple, including technical (limited internet access, difficulties in using the platform, etc.) and human (difficulties in expressing themselves in front of the camera, etc.) features, as well as medical doctors’ unavailability. These multiple reasons likely introduced a significant bias in result interpretation, as revealed by other authors.10,13,14 Our data clearly indicate usefulness of diabetology teleconsultation in pandemic circumstances.
Authors’ Contributions
Conceptualization: L.M. and L.K.; Data curation and format analysis: T.F., N.M., and L.A.; Funding acquisition: L.K.; Investigation: L.M., M.F., T.B., F.O., D.P., M.M., S.B.S., C.Ca., C.Ch., and L.K.; Methodology: L.M., T.F., L.M., and L.K.; Project administration: N.M. and L.K.; Resources: L.M., L.A., and L.K.; Supervision: L.M. and L.K.; Validation: T.F., N.M., and L.K.; Visualization: L.A.; Roles/Writing- original draft: L.M. and L.K.; Writing-review and editing: L.M., T.B., F.O., D.P., M.M., S.B.S., C.Ca., C.Ch., N.M., and L.K.
Acknowledgments
The authors are indebted to the staff of the Endocrinology, Diabetology, and Nutrition Department, the liberal diabetology practice office in Strasbourg, and the Direction de la Recherche Clinique of Strasbourg University Hospital. Article edition was provided by Dr Kate Dunning (University Hospital of Strasbourg).
Disclosure Statement
No potential conflicts of interest relevant to this article were reported.
Funding Information
Part of this work was supported by Home Health Providers, ASDIA and ELIVIE.
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