This study sought to assess the feasibility and effectiveness of implementing SMBG among insulin-dependent type 2 DM patients receiving care in three rural district hospitals in Rwanda.
We conducted a six-month open randomized controlled trial, including patients diagnosed with type 2 DM taking insulin and being managed at outpatient non-communicable disease (NCD) clinics in three rural Rwandan district hospitals. This study adhered to CONSORT guidelines.
The study was conducted at the three public district level hospitals in rural Rwanda: Kirehe and Rwinkwavu district hospitals in the Eastern Province, and Butaro district hospital in the Northern Province. As described elsewhere , the three district hospitals are under the supervision of the Rwanda Ministry of Health (RMOH) and receive regular technical and financial support from Partners In Health/Inshuti Mu Buzima (PIH/IMB)—a non-governmental organization that has been supporting health care services in Rwanda since 2005.
In Rwanda, patients with insulin-dependent type 2 DM receive routine care at integrated NCD outpatient clinics, known as PEN-Plus. This nurse-led approach builds on the WHO PEN (Package of Essential Non-communicable diseases) model, which is primarily focused on common, non-severe NCDs, such as mild to moderate hypertension and non-insulin-dependent diabetes, at health centers . PEN-Plus clinics are based at district hospitals and focus on the management of severe NCDs, such as insulin-dependent type 1 and 2 DM and heart failure . Type 2 DM patients are referred to these clinics from in-patient hospital facilities, the general outpatient facility or from lower level facilities, such as health centers.
The management of type 2 DM patients in these clinics is guided by standardized national diabetes treatment protocols developed by the Rwandan MOH in collaboration with PIH/IMB and other partners. The criteria to initiate insulin medication among the diabetes patients is outlined in the treatment protocols .
The study focused on patients with insulin-dependent type 2 DM and enrolled in PEN-Plus clinics at one of the three district hospitals.
Inclusion and exclusion criteria
Adults aged at least 18 years of age diagnosed with insulin dependent type 2 DM and receiving an insulin regiment at the time of study at one of the three above listed district hospitals were eligible. Patients also had to demonstrate an ability to read or had a reliable person who could write sufficiently to record glucose level readings into study provided log-books. Eligible participants must have had the most recent HbA1C recording at 7% or greater.
Participants were excluded if they had a diagnosis of type 1 diabetes, gestational diabetes or chronic kidney disease or were unable to read and write sufficiently to use log-books and had no reliable person who would assist in reading the glucose levels and using the log-book.
Enrollment of participants
Participants were identified through electronic medical records at the three district hospitals and those eligible were recruited and enrolled sequentially from April to June 2019. Study participants were followed monthly for a period of six months from their date of enrollment. Data collection occurred from April to December 2019.
Sample size and power
All patients with insulin-dependent type 2 DM at the three hospitals who met the inclusion and exclusion criteria were included. From previous literature in this setting, we assumed that the change in HbA1C would be 0.2% among the control group  and 1.2% among the intervention group . With a standard deviation of 1.9% or less, our eligible sample size of 82 study participants would yield a power of greater than 80% to detect the mean difference of the change in HbA1c among the intervention group compared to that of the control group.
A simple random allocation sequence for each of the three study sites was computer generated by the research associate who did not have access to patient’s clinical records and was not involved in patient enrollment. The research study coordinator, who was also responsible for the recruitment process conducted the allocation process using sealed envelopes. Participant distribution followed a 1:1 ratio between study groups.
Both the intervention and control groups continued with their usual DM management, which consisted of routine monthly medical consultation and education. In addition, the intervention group was given an SMBG kit comprising of glucose meter machine, log-books, blood lancets and test strips to implement SMBG at home. All participants in the intervention group received training targeted towards integrating SMBG. The training topics included appropriate use of the SMBG kits and proper waste disposal mechanisms. Additionally, educators reviewed the signs and symptoms of hypo- and hyperglycemia and course of action in case the participants experienced such episodes. While the training on hypo- and hyperglycemia are part of the routine education curriculum, this SMBG education session integrated the use of glucose meters to inform self-management of such episodes. Participants were instructed to take their blood glucose levels every day of the week, conducting one test per day. The daily testing followed a schedule of alternating the time of day for testing. The set times included morning, midday, and evening (post-meal). Participants were also given a mobile phone number belonging to the study coordinator to communicate in-case of any concerns or questions related to implementing the SMBG.
The control group did not receive any additional changes to its day-to-day care.
The outcome measures were assessed at enrollment, three months and six months’ post-intervention. At enrollment, demographic and self-reported basic clinical measures were collected using a standard questionnaire. We collected demographic information and clinical variables including: sex, age, marital status, education level, occupation, body mass index, waist, circumference, duration since diagnosis with insulin, and insulin regimen used. The primary and secondary study outcomes are described as follows.
The primary outcome measures were: 1) the change in HbA1c which was performed using point of care devices (SD A1cCare) and required a lancet-induced drop of blood collected from the participant’s fingertip. The resulting percent value reflected the participant’s blood glucose level over the past 1–3 months. 2) Implementation feasibility outcomes including adherence to SMBG which was measured by the participant’s adherence to the use of glucose meter and recording DM readings into log-books while practicing SMBG. Adherence to SMBG was calculated by dividing the actual number of SMBG readings recorded on the patient’s glucose meter and log book records by the expected number of SMBG glucose readings at six months. Participants with proportions of 80% or above were considered to have good adherence to SMBG while those less than 80% were considered to have poor adherence.
A secondary implementation outcome was the reliability of log-books, which was measured among the intervention group by comparing what was recorded in the log-book to what was automatically recorded by the glucose meter machine. Lastly, mean blood glucose readings were calculated as the row means of the overall glucose meter readings for each of the study participants.
Frequencies, percentages, means and standard deviations (SD), medians and interquartile range (IQR) were used to report continuous variables. A paired t-test was used to assess the change in HbA1c within the intervention and control group, while a two-sample t-test was used to assess the mean differences of HbA1c for the intervention group compared to the control group. We used the Wilcoxon rank sum test to test the association of demographic variables and the mean blood glucose for continuous variables and chi-square or fishers test for the categorical variables. Stata version 15 software was used to conduct the analysis.