p
ABSTRACT
Diabetes is a serious public health issue that is increasingly undermining the health and well-being of individuals world-wide. The disease particularly burdens low and middle-income countries, where spending and resources for treatment and prevention are scarce. To address the inadequacies in diabetes care, the Life for a Child Program (LFAC) has been established for youth diagnosed with Type 1 Diabetes in many low and middle-income countries, including Rwanda. The LFAC program works throughout all of Rwanda alongside the Association Rwandaise des Diabetiques (ARD) to provide specialized care to youth in order for them to successfully manage their diabetes and prevent complications or even death. However, given that Rwanda is a low-income country, food insecurity is widespread, which presents a challenge to youth with type 1 diabetes, as diet is a vital component in diabetes management. Specifically, the timing, frequency, and content of meals is important as individuals must coordinate their insulin dosage with food intake to prevent hyperglycemia or hypoglycemia, which will help them achieve glycemic control. This paper examines the role of the dietary patterns of youth diagnosed with Type 1 Diabetes in Rwanda to assess whether specific dietary patterns are associated with better glycemic control.
2
TABLE OF CONTENTS
1.0 INTRODUCTION 1
2.0 METHODS 4
3.0 Results 9
4.0 Discussion 15
5.0 conclusion 20
Appendix A: OVERVIEW 21
Appendix B: TABLES AND FIGURES 26
bibliography 38
List of tables
Table 1: Characteristics of the 2014 LFAC Cohort Overall and by Gender 26
Table 2: Spearman Correlation Coefficients and P-Values for HbA1c and Dietary Variables Overall and by Gender 28
Table 3: Mean HbA1c for Dietary Variables 29
List of figures
Figure 1: Meal Frequency Distribution 30
Figure 2: Percent Distribution of Meal Frequency Categories 31
Figure 3: Percent Distribution of Large Meals 32
Figure 4: Percent Distribution of Snacks 33
Figure 5: Percent Distribution of HbA1c Categories 34
Figure 6: Mean HbA1c by Meal Frequency Categories 35
Figure 7: Mean HbA1c by Large Meal Categories 36
Figure 8: Mean HbA1c by Snack Intake 37
2
1.0 INTRODUCTION
Diabetes is an emerging public health issue in Sub-Saharan Africa. It is estimated that 19.8 million people in the region currently live with diabetes, a number that is expected to increase 109% to 41.4 million by 2035 (1). The three main types of diabetes are type 1 diabetes, type 2 diabetes, and gestational diabetes, all of which occur when insulin is not produced or used effectively (1). Type 1 diabetes is an autoimmune disorder, which presents itself mainly in children and adolescents and requires life long insulin dependency (1, 2). Type 2 diabetes is the most common type and is characterized by insulin resistance that results in a build up of glucose in the blood, typically attributed to lifestyle factors including diet and inactivity (1, 2). Gestational diabetes occurs during pregnancy, when hormones produced by the placenta block insulin; this blockage results in insulin resistance and consequently high blood sugars and carries a high risk of type 2 diabetes later in life (1).
Within the African region, youth with type 1 diabetes often go undiagnosed. However, even if diagnosed in a timely manner, low and middle-income countries have limited resources that make it difficult for individuals with diabetes to effectively achieve glycemic control, which leads to the development of diabetes complications and subsequently death. In particular, food insecurity, or the insufficient access to safe and nutritional food, is a major risk factor for poor glycemic control and hypoglycemia(3). Food insecure individuals are forced into poor eating patterns and have to skip meals, reduce meal size, and sometimes enter binge-fasting cycles (4). As a result, those who are food insecure and have diabetes report a greater number of hypoglycemia and ketoacidosis events and have higher HbA1c levels (3). Thus, these individuals face optimal diet barriers, as they are unable to modify their daily food selection to coordinate with their insulin regimens. This especially occurs because they have a fear of hypoglycemia, which leads to inadequate insulin dosage and growth issues, as well as poor glycemic control. Limited financial resources also restrict their ability to purchase quality food and appropriate glycemic control equipment (5).
Children diagnosed with poorly controlled type 1 diabetes (T1D) often experience weight loss, dehydration, and insufficient energy intake, and as a result, hydration as well as insulin initiation are necessary to restore normal weight gain, growth, and development; however, since energy requirements change with age, frequent nutritional assessments should be established (5). Diet is a crucial component in controlling blood sugar levels. A balanced diet consisting of fats and proteins, and avoiding high glycemic index foods is recommended for diabetes management. Additionally carbohydrate intake is central individuals with type 1 diabetes, who can develop short-term complications, such as hypoglycemia, hyperglycemia or diabetic ketoacidosis, as a result of mismatched carbohydrate intake and insulin, as evidence suggests total meal carbohydrate content is vital in post-prandial glucose response and therefore insulin dosage (4,5). Therefore, children who have fixed insulin, particularly long acting doses require appropriate food intake in terms of both content and timing (5). Studies have shown the use of carbohydrate counting and insulin-to-carbohydrate ratio as sources of diabetes management increase patient satisfaction and decreased HbA1c levels (5).
The two most widely used insulin regimens for type 1 diabetes are the combination of neutral protamine Hagedorn (NPH), an intermediate acting insulin lasting twelve hours, and regular insulin (R), a short acting insulin lasting six hours or the basal bolus regimen. The NPH and R combination can be combined into a single injection and is usually taken in the morning and evening with meals (6). The combination regimen allows individuals to adjust the dosage of each type independently according to blood sugars and meal size, time, and content. A premixed NPH and R insulin regimen is available and intended to simplify dosing but does not allow the NPH or R to be changed independently for individuals. Thus, premixed insulin regimens suffer from poor flexibility, which increases the risk of hypoglycemia, as a fixed meal plan is necessary (7). The basal bolus regimen comprises long acting basil insulin, which lasts approximately 24 hours after a once-daily administration and is supplemented with doses of short acting insulin at each meal, which closely mimics physiological insulin secretion (7). This regimen allows individuals to independently adjust the dosages according to blood sugar, and as a result presents greater flexibility over meal times and a varied dose response to different carbohydrate quantities in meals (8).
As the effect of diet on glucose control in Rwandan youth with type 1 diabetes has not been previously studied, the primary objective of this paper is to examine the role of dietary patterns on glycemic control among type 1 diabetic youth who participated in the Life For a Child (LFAC) program. Using routinely collected data on dietary habits, including meal frequency, meal size, and snacks, in addition to clinical indicators such as HbA1c and blood pressure, this paper seeks to determine whether associations exist between the size of meals, frequency of meals, and snack intake on HbA1c. This work builds upon that of prior doctoral students who collaborated on the LFAC study, including that of Sara Marshall who examined various aspects of diabetes care and management and reported on clinical status, glucose control, and complication rates in this cohort.
2.0 METHODS
This paper involves a project evaluation of the LFAC program in collaboration with the Association Rwandaise des Diabetiques (ARD) and The University of Pittsburgh Graduate School of Public Health. The University of Pittsburgh’s IRB has determined that this project is exempt from review under the ‘Existing Data’ category.
Study Population:
The participants of this program evaluation are registered participants of the Rwanda Life for A Child Program. In order to be enrolled in the program, the participant must be a resident of Rwanda, 25 years of age or younger, and in need of assistance obtaining diabetes supplies. Participants of the LFAC program arrived at the ARD or district hospital for care or were referred to the ARD by a healthcare provider.
Data Collection:
This project will focus on data that were collected from 256 participants between May 2014 and July 2014. Data were collected by the ARD staff, who were aided by myself, a University of Pittsburgh Graduate School of Public Health student during this period. As a student, I received training prior to arriving in Rwanda on how to conduct the relevant clinical and laboratory assessments.
LFAC annual or quarterly forms and protocols were used to collect data at the ARD and twenty district hospitals, utilizing previously and routinely collected data that is used for clinical program purposes. No data were collected for research purposes. Medical and clinical examinations, facilitated by ARD staff, were conducted, as detailed below.
LFAC Examination Forms:
The LFAC program has developed examination data protocols for annual and quarterly clinical assessments, the former of which is required for each participant supported by the program.
Complete clinical and complication history of each participant enrolled in the program was abstracted annually using standardized LFAC forms. Information on these forms include: date of birth, date of diagnosis, meter status, insulin regimen, number of insulin injections, number of insulin units per day, blood pressure medication, number of annual clinic visits, weight, height, blood pressure, neuropathy assessment (as determined by a monofilament and tuning fork test), vision assessment, HbA1c, Albumin-Creatinine (A/C) ratio, school attendance (those attending school and if those attending school are in the appropriate grade for age), number of hyper/hypoglycemic events, and number of hospitalizations.
Quarterly LFAC forms are used every three months to monitor the participants’ adherence to glucose monitoring and administration plans. Information collected on these forms includes: glucose monitoring per week, insulin regimen, weight, height, blood pressure, HbA1c, and A/C ratio (only if annual assessment value was >30 mg/g).
Laboratory Data:
MPH students and ARD staff collected a blood sample on each participant, by a finger prick, which was used to collect a blood sugar, using a Nipro TRUETrack glucometer, and HbA1c, using the Siemens DCA Vantage System. The Nipro TRUETrack meter reports blood glucose values of 20-600 mg/dl and any values outside this range are reported as “Lo” or “Hi”. The Siemens DCA Vantage reports a maximum HbA1c value of >14%, therefore, for data analysis purposes these results were recorded as 14.1%. A spot urine sample was also collected from each patient and processed using the Siemens DCA Vantage System to report A/C ratio.
Complication Assessment:
Neuropathy: Neuropathy was assessed using a monofilament and 128 Hz tuning fork test. The monofilament was applied to the dorsum of each of the big toes of participants a total of ten times. A response to seven or more of the ten applications on each foot was considered a normal response. The vibrating tuning fork was applied to the dorsum of each big toe, and an abnormal test result was recorded if a patient was unable to feel the vibrations within ten seconds. The presence of neuropathy was recorded if either/or both an abnormal monofilament and abnormal tuning fork resulted.
Hypertension: Hypertension was defined as having a systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 80 mmHg in patients 18 years or older. For patients younger than 18 years of age, hypertension was defined as a systolic and/or diastolic blood pressure ≥ the 95th percentile according to their age, sex and height, using the CDC Growth Charts and Department of Health and Human Services Blood Pressure Percentile Tables.
Microalbuminuria: Microalbuminuria (MA) was defined as an albumin/Creatinine (A/C) ratio of 30-299 mg/g in a spot urine sample.
Nephropathy: Nephropathy was defined as an A/C ratio of greater or equal to 300 mg/g in a spot urine sample.
Dietary Patterns:
As part of the clinical assessment, the ARD staff ascertains information on dietary habits, including the frequency, size, and timing of meals as well as snack intake in order to prescribe the correct insulin regimen and successfully achieve glucose control.
Meal Frequency: Meal frequency was measured as the number of times a participant ate per day. However, given the food insecurity in the country, if the number of meals fluctuated each day the midpoint was taken.
Meal Size: Meal size was determined to be small, medium, or large portion sizes as demonstrated to participants by the staff using hand gestures. No standard portion size models were used.
Meal Times: The timing of meals was defined as when patients consumed each of their meals per day. Meal times were divided into morning, afternoon, and evening.
Snacks: A patient was recorded as taking a snack if they responded positively to consuming a small amount of food between meals at least once per week.
Meal points: To provide a summary score of food intake a meal point score was calculated. The size of meals were assigned a numeric value of 1 for small, 2 for medium, and 3 for large. These points were then assigned to each meal per day and the resulting sum was the total number of meal points per day. If the number of meals per day fluctuated, the midpoint was taken.
Data analysis:
Descriptive statistics, which include mean, standard deviation, median, and frequencies, were calculated for all variables. Median and interquartile range were reported if the variable was non-normally distributed and mean and standard deviation were reported if the variable was normally distributed. Two-sample t-tests were used to assess differences among continuous variables and chi-square tests were used to assess differences among categorical variables. A p-value of <0.05 was used to determine whether a significant association existed among variables. When analyzing data on nutrition, only participants who reported complete data on nutrition were included. The analysis for this report was generated using SAS software Version 9.4 of the SAS System for Windows copyright 2014 SAS Institute Inc.
3.0 Results
Data were collected on 253 youth between 29 May 2014 and 8 July 2014. The study population consisted of slightly more females than male, with 60% (n=153) females and 40% (n=100) males (Table 1). The overall median age was 21 years (Interquartile range 18, 24), age at diagnosis 17 years (IQR 14, 19), and duration of diabetes 4 years (IQR 2, 6). The median duration of diabetes for females was 3 years (IQR 2, 6), which was not significantly lower than the duration of diabetes of 4 years for males (IQR 2, 6), p=0.71