Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04640064 |
| Other study ID # |
0019 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2020 |
| Est. completion date |
April 22, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
Hospital General Puyo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A multicenter retrospective observational study among children with type 1 diabetes will be
performed. The Objective of this study will be to determine a) the association between the
increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19
pandemic. b) the association between the frequency of patient care during social confinement
and the Hba1c values. Different centers from Latin America including Argentina, Peru, Panama,
Chile, and Ecuador will participate in this study. Children younger than 17 years with a
diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of
the participating centers will be collected on the Hb A1c value before and after confinement
(6 months completed). The initial (base) value will be taken as a value of HbA1c registered
in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine
(Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have
been performed in the same institution or with the same methods in order to avoid bias.
Description:
Research protocol Hb A1C pre and post Confinement in Latin American children with Type 1
Diabetes: Dulce Study Group
The coronavirus disease is caused by an RNA virus called SARS-CoV-2 (severe acute respiratory
syndrome coronavirus 2) that has spikes on its surface that give a crown appearance under the
electron microscope; hence its name.
A recent cluster of pneumonia cases in Wuhan, China, was caused by this new coronavirus,
SARS-CoV-2. In December 2019, adults in Wuhan, a central transportation hub in China, began
presenting severe pneumonia of unknown origin in local hospitals. On December 31, 2019, China
notified the WHO of the outbreak. On January 7, the virus was identified as a SARS-CoV-2. It
soon became known that the disease could be transmitted from asymptomatic people and before
the onset of symptoms. The infection is acquired either by inhaling drops or touching
contaminated surfaces and then touching the nose, mouth, and eyes. The virus is also present
in the stool.
The incubation period ranges from 2 to 14 d [median 5 d]. Studies have identified the
angiotensin 2 receptor as the receptor through which the virus enters the respiratory mucosa.
(1)
What happens in children? Less than 1% of the cases were in children under the age of 10 in
Wuhan, China. Unlike adults, most children have a milder clinical course.
One review included 18 studies with 1065 participants with confirmed SARS-CoV-2 infection.
All articles were from China, except for one clinical case in Singapore. Most children had
mild respiratory symptoms, such as fever, dry cough, fatigue, or asymptomatic. Bronchial
thickening and ground-glass opacities were the main radiographic features in symptomatic or
asymptomatic patients. There was only 1 case of severe COVID-19 infection, among the articles
included, in a 13-month-old baby. None died. In general, pediatric COVID-19 patients had a
good prognosis and recovered within 1 to 2 weeks after illness onset. However, children with
mild symptoms or asymptomatic can be a source of viral transmission, constituting essential
data for the prevention of the pandemic (2,3).
Food insecurity has been linked to the risk of obesity during the pandemic. Individuals are
buying ultra-processed, high-calorie foods. As farms dump food like milk and eggs, grocery
stores see empty shelves of cookies, chips, sodas and juices, sugary cereals, and
ready-to-eat processed foods. Therefore, we anticipate that many individuals will experience
high-calorie diets during the pandemic. (4) There is a greater impact in urban areas of an
increasingly sedentary lifestyle. The time in front of the screen, video games, etc., is
associated with overweight and obesity due to the double problem (longer sedentary time and
increased snacks).
What happens in children with diabetes?
Different studies observed a higher risk of morbidity and mortality in older adults who also
had diabetes, hypertension, and other risk factors associated with cardiovascular disease.
(5)
Diabetes and Pandemic
Latin America includes developing countries with limited resources. In the absence of
specific available and approved vaccines and treatments for COVID-19, the only public health
tools available are confinement and social distancing (6). These countries implemented strict
social restrictions to stop transmission, including complete border closures, restricted
movements during day and night, and inter-provincial travel cessation. However, this measure
could generate consequences related to the impact of confinement in vulnerable populations
such as patients with diabetes mellitus, worsening glycemic control, and increasing the
progression of chronic complications related to the disease. Diabetic children had less
access to physical activity, healthy eating, and the frequency of face-to-face clinical
consultation. Glycosylated hemoglobin (HbA1C) reflects the average blood glucose of the last
3 months. This test is the main tool for assessing glycemic control and is associated with a
high predictive value for diabetes complications. It should be performed routinely in all
patients with diabetes at the initial evaluation and as part of the follow-up. Measurement
every three months determines whether the patients' blood glucose goals have been achieved
and maintained (7).
We believe in the need to develop epidemiological tools to measure the impact of the control
of diabetes in children by the crisis and improve the understanding of the patterns of
diabetes care during the pandemic. We have not found in the references works on the increase
of A1c in Latin America before and after confinement. That is why we have developed this
protocol.
The Objective of this study will be to determine a) the association between the increase in
Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic. b) the
association between the frequency of patient care during social confinement and the Hba1c
values.
Exclusion Criteria: pregnancy, kidney failure, treatments that alter hydrocarbon metabolism
(corticosteroids, chemotherapy, etc.) and chronic iron deficiency pathologies that alter the
value of HbA1c.
Material and methods:
A multicenter retrospective observational study among children with type 1 diabetes will be
performed. Different centers from Latin America including Argentina, Peru, Panama, Chile, and
Ecuador will participate in this study. Children younger than 17 years with a diagnosis of
type 1 diabetes prior to 2018 will be included. Data from the medical records of the
participating centers will be collected on the Hb A1c value before and after confinement (6
months completed). The initial (base) value will be taken as a value of HbA1c registered in
the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine
(Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have
been performed in the same institution or with the same methods in order to avoid bias.
The years will be divided into four-month periods (quartiles). The Hba1c will be recorded in
each period. If a patient had two HbA1c values in the same quarter, the values would be
averaged. If there is no value of HbA1C in a period, N / A would be placed in the box.
In addition, the impact of confinement on the BMI registered in the semesters (provided that
the data is available) 2018, 2019, and 2020 will be completed. The number of consultations
made during 2018,2019 and 2020 by each patient will be completed in the corresponding boxes.
The number of telemedicine consultations during the quarantine period will be completed.
Children with type 1 diabetes patients from different private and public centers of Latin
America will be included. The sampling frame will be their medical records. The sample is
made up of clusters (public or private center) in a single stage since all medical records
that meet the selection criteria will be reviewed
Other data to be recorded for analysis will be: public or private setting, date of birth, the
weight of birth, age, sex, nationality, blood pressure (BP), lipids ( total cholesterol,
triglycerides, and HDL-C), vitamin D, date of onset of diabetes, treatment type (traditional,
multiple doses, or insulin pump).
For the collection and processing of the data, a spreadsheet will be used and then the data
will be uploaded to REDCAP and statistical packages It is important to clarify that the local
researcher will prepare the institution's database anonymously and that when the shipment is
made, data to other institutions, it will not be possible to individualize patients, to
guarantee the anonymity of patients and the confidentiality of their health data. The last
four passport numbers will be used.
The χ2 test will be used to compare proportions. When more than 20% of the cells have
expected frequencies <5, Fisher will use the exact test. The adjustment to the normal
distribution of continuous variables will be evaluated using the Shapiro-Wilks method. When
comparing two groups with normal distribution data, the Student's t test will be performed.
When the homogeneity of the variances cannot be tested, the Brown Forsyth test will be used.
Variables with asymmetric distribution will be log-transformed for analysis.
Several multiple regressions analyses will be performed to examine the relationship between
Hb A1c as a dependent variable and BMI, age, sex, frequency of visits, age of diabetes,
duration of confinement, lipids, vitamin D, etc. as the independent variables. Values of P
<0.05 will be considered significant. The Bonferroni adjustment will be carried out when
numerous comparisons are made. Data will be presented as means ± standard deviations. The
analyzes will be performed using the statistical software SPSS® (Chicago, IL) version 21.0. A
value of p <0.05 will be considered statistically significant
Data collection
DATE NUMBER NAME PASSPORT SEX AGE ( years BIRTH DATE BIRTH WEIGHT (kG) DATE NUMBER OR
COSULTATIONS 2018 2019 2020 INSULIN type HBA1C 2018 1 2 3 HBA1C 2019 1 2 3 HBA1C 2020 1 2 3
HEIGHT 2018 1 2 3 WEIGHT 2018 1 2 3 BMI 2018 1 2 3 HEIGHT 2019 1 2 3 WEIGHT 2019 1 2 3 BMI
2019 1 2 3 HEIGHT 2020 1 2 3 WEIGHT 2020 1 2 3 BMI 2020 1 2 3 Cholesterol total mg/dL 2018
2019 2020 HDL-C mg/dL 2018 2019 2020 TRIGLYCERIDES mg/dL 2018 2019 2020 Vitamin D (Nanograms)
2018 2019 2020 SBP 2018 mmHg 1 2 3 SBP 2019 mmHg 1 2 3 SBP 2020 mmHg 1 2 3 DBP 2018 mmHg 1 2
3 DBP 2019 mmHg 1 2 3 DBP 2020 mmHg 1 2 3 Treatment Conventional Treatment Muultiple Doses
CSII COVID Positive Yes/NO
References:
1. The Indian Journal of Pediatrics (April 2020) 87(4):281-286
https://doi.org/10.1007/s12098-020-03263-6)
2. N Engl J Med 2020; 382:1663-1665 DOI: 10.1056/NEJMc2005073 & Pediatrics. 2020 Mar
16;e20200702. doi: 10.1542/peds.2020-0702)
3. JAMA Pediatr. Published online April 22, 2020. doi:10.1001/jamapediatrics.2020.146.)
4. Effects of COVID-19 Lockdown on Lifestyle Behaviors in Children with Obesity Living in
Verona, Italy: A Longitudinal Study. Obesity (Silver Spring). 2020 Apr
30;10.1002/oby.22861. doi: 10.1002/oby.22861)
5. BMJ 2020;368:m1198 doi: 10.1136/bmj.m1198 (Published 26 March 2020; Bo Li1 • Jing
Yang1,2 • Faming Zhao et. Al. Clinical Research in Cardiology (2020) 109:531-538.
https://doi.org/10.1007/s00392-020-01626-9).
6. Miller MJ, Loaiza JR, Takyar A, Gilman RH. PLoS Negl Trop Dis. 2020 May; 14(5):
e0008265. doi: 10.1371/journal.pntd.0008265.)
7. Ghosal y col, ( S. Ghosal et al. Diabetes & Metabolic Syndrome: Clinical Research &
Reviews 14 (2020) 319e323320).
