Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa.

BACKGROUND: Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. METHOD: We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. RESULTS: We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808 ). CONCLUSION: The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

"It's got its own life, and you can't contain it": A qualitative study of patient and health professional experiences of diabetes care.

AIMS AND OBJECTIVES: To explore the perspectives of patients and health professionals on facilitators and barriers to care in a diabetes clinic in urban South Africa. BACKGROUND: Although much attention has been given to the science behind diabetes management, a qualitative approach to exploring experiences, facilitators and barriers to care may have considerable value in understanding and improving diabetes care. DESIGN: We conducted a qualitative study in the context of a 3-year collaboration at a diabetes clinic. The present study formed part of the preparatory phase to the larger project. METHODS: Linguistically and culturally matched research assistants collected data over a period of 18 months. Methods included interviews, focus groups, ethnographic observations and informal discussions with 38 patients and health professionals. Data from each participant group were transcribed, translated and analysed using reflexive thematic analysis principles and thereafter triangulated. The Standards for Reporting Qualitative Research checklist was followed. RESULTS: Initial findings suggest that factors can be classified into three overarching themes: relationships, health systems and the interplay between disease and the lifeworld. System resource pressures, the nuances of team interactions and a complex healthcare site may adversely affect care, even at sites where there are elements of good practice. CONCLUSIONS: The collective psychosocial experience of patients appears to conflict with the biomedical approach to diabetes management. The all-consuming nature of the disease, together with contextual and systemic factors, plays a significant role in influencing experiences of care. RELEVANCE TO CLINICAL PRACTICE: While systemic and contextual influences on experiences of diabetes care may be difficult to modify, our study suggests a need to focus on ways of enhancing relationships within the clinic and seeking to understand the lifeworld of the patient.

Health Care Resource Utilization in Adults Living With Type 1 Diabetes Mellitus in the South African Public Health Sector: Protocol for a 1-Year Retrospective Analysis With a 5-, 10-, and 25-Year Projection.

BACKGROUND: Type 1 diabetes mellitus (T1DM) is less common than type 2 diabetes mellitus but is increasing in frequency in South Africa. It tends to affect younger individuals, and upon diagnosis, exogenous insulin is essential for survival. In South Africa, the health care system is divided into private and public health care systems. The private system is well resourced, whereas the public sector, which treats more than 80% of the population, has minimal resources. There are currently no studies in South Africa, and Africa at large, that have evaluated the immediate and long-term costs of managing people living with T1DM in the public sector. OBJECTIVE: The primary objective was to quantify the cost of health care resource utilization over a 12-month period in patients with controlled and uncontrolled T1DM in the public health care sector. In addition, we will project costs for 5, 10, and 25 years and determine if there are cost differences in managing subsets of patients who achieve glycemic control (hemoglobin A1c [HbA1c] <7%) and those who do not. METHODS: The study was performed in accordance with Good Epidemiological Practice. Ethical clearance and institutional permissions were acquired. Clinical data were collected from 2 tertiary hospitals in South Africa. Patients with T1DM, who provided written informed consent, and who satisfied the inclusion criteria were enrolled in the study. Data collection included demographic and clinical characteristics, acute and chronic complications, hospital admissions, and so on. We plan to perform a cost-effectiveness analysis to quantify the costs of health care utilization in the preceding 12 months. In addition, we will estimate projected costs over the next 10 years, assuming that study participants maintain their current HbA1c level. The cost-effectiveness analysis will be modeled using the IQVIA CORE Diabetes Model. The primary outcome measures are incremental quality-adjusted life years, incremental costs, incremental cost-effectiveness ratios, and incremental life years. RESULTS: Ethical clearance and institutional approval were obtained (reference number 200407). Enrollment began on February 9, 2021, and was completed on August 24, 2021, with 224 participants. A database lock was performed on October 29, 2021. The statistical analysis and clinical study report were completed in January 2022. CONCLUSIONS: At present, there are no data assessing the short- and long-term costs of managing patients with T1DM in the South African public sector. It is hoped that the findings of this study will help policy makers optimally use limited resources to reduce morbidity and mortality in people living with T1DM. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/44308.

Healthcare Resource Utilization in Controlled Versus Uncontrolled Adults Living With Type 1 Diabetes in the South African Public Healthcare Sector.

OBJECTIVES: This study aimed to understand the cost implications of managing people living with type 1 diabetes mellitus in the South African public healthcare system. METHODS: A multicenter, noninterventional retrospective chart review study was performed. Data on healthcare resource consumption, demographics, risk factors, clinical history, and acute events were collected. Direct medical costs were collected over a 1-year period, stratified by controlled versus uncontrolled patients. In addition, the costs in people with controlled (glycated hemoglobin < 7%) versus uncontrolled glycated hemoglobin (≥ 7%) at time horizons of 1, 5, 10, and 25 years were modeled using the IQVIA Core Diabetes Model. RESULTS: The costs based on the retrospective chart review were $630 versus $1012 (controlled versus uncontrolled population). The modeled costs at various time horizons were as follows: at 1 year, $900 versus $1331; at 5 years, $4163 versus $6423; at 10 years, $7759 versus $16 481; and at 25 years, $16 969 versus $66 268. The largest cost in the controlled population was severe hypoglycemia requiring nonmedical assistance, severe hypoglycemia requiring medical assistance, and treatment costs. In the uncontrolled population, the largest cost was the cost of diabetic ketoacidosis, severe hypoglycemia requiring nonmedical assistance, severe hypoglycemia requiring medical assistance, and foot complications. CONCLUSIONS: Strict glycemic control reduces healthcare resource use overall. Patients in the controlled group still experienced high resource use related to hypoglycemic events. The introduction of a structured patient education program and analog insulins may result in less episodes of hypoglycemia and potential cost savings.

Mobile Messaging Support Versus Usual Care for People With Type 2 Diabetes on Glycemic Control: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicine regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making the best use of medicine in low- and middle-income settings are scarce. Mobile phones are widely available in these settings, including among people with diabetes; linked technologies, such as short message service (SMS) text messaging, have shown promise in delivering low-cost interventions efficiently. However, evidence showing that these interventions will work when carried out at a larger scale and measuring the extent to which they will improve health outcomes when added to usual care is limited. OBJECTIVE: The objective of this trial is to test the effectiveness of sending brief, automated SMS text messages for improving health outcomes and medication adherence in patients with type 2 diabetes compared to an active control. METHODS: We will carry out a randomized trial recruiting from clinics in two contrasting settings in sub-Saharan Africa: Cape Town, South Africa, and Lilongwe, Malawi. Intervention messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We allocated patients, using randomization with a minimization algorithm, to receive either three to four intervention messages per week or non-health-related messages every 6 weeks. We will follow up with participants for 12 months, measuring important risk factors for poor health outcomes and complications in diabetes. This will enable us to estimate potential health benefits, including the primary outcome of hemoglobin A1c (HbA1c) levels as a marker for long-term blood glucose control and a secondary outcome of blood pressure control. We will record the costs of performing these activities and estimate cost-effectiveness. We will also use process evaluation to capture the collection of medication and assess the reception of the intervention by participants and health care workers. RESULTS: Recruitment to the trial began in September 2016 and follow-up of participants was completed in October 2018. Data collection from electronic health records and other routinely collected sources is continuing. The database lock is anticipated in June 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from this study will have wide applications and advance the evidence base for effectiveness of mobile phone-based, brief text messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness and acceptability that will further inform policy development and decision making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. TRIAL REGISTRATION: ISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12377.

Implementation of POCT in the diabetic clinic in a large hospital.

AIM: Point-of-care testing (POCT) is gaining renewed interest, especially in resource-limiting primary health care, due to rise in prevalence of communicable and non-communicable diseases hence POCT needscontinuous appraisal. METHODS: Random glucose and glycated haemoglobin (HbA1c) were measured in 104 diabetic patients using standard laboratory multichannel analyzer 917. The utility of venous blood compared to capillary blood in measuring HbA1c was evaluated in a subset of 20 patients using a POCT device, DCA Vantage. Lastly, the POCT was validated against the laboratory multichannel analyser 917, in measurement of HbA1c in a second subset of 46 patients. RESULTS: Random blood glucose levels and HbA1c levels moderately correlated (r2 = 0.56; p < 0.0001). Random glucose tests showed that 41% of the patients had poor glycaemic control while HbA1c showed 74%. Venous and capillary blood in HbA1c showed strong correlation (r2 = 0.89440; p < 0.001. There was also strong correlation (r = 0.9802; p < 0.0001) in HbA1c measured using the DCA Vantage and the standard laboratory analyser, Multichannel Analyser 917. CONCLUSION: Venous or capillary blood can be used in POCT for HbA1c. POCT is ideal for monitoring glucose control and management of diabetes in resource-limited countries such as South Africa.

Critical appraisal of the recent data published on the link between insulin and cancer.

Recent publications indicate a possible association between newer analogue insulin Glargine and cancer. However all these data were observational in nature and subject to lot of methodological errors. It is practically impossible to derive at a cause and effect relationship based on these observational studies. There are several confounding factors like hyperinsulinemia, obesity and smoking, which independently can be associated with cancer risk. This review looks into the recently published observational studies from the methodological point of view and whether such a negative association can indeed be drawn as a conclusion. Several methodological defects were identified in the process of scrutiny and we concluded it is not possible to conclude that there is an association between Glargine use and cancer. However long-term prospective data is required to come to definite conclusion.