Dataset Information

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.

ABSTRACT: INTRODUCTION:Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement. METHODS AND ANALYSIS:This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants. ETHICS AND DISSEMINATION:This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:PACTR201905538846394; pre-results.

SUBMITTER: Ng'ang'a L

PROVIDER: S-EPMC7389513 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.

Ng'ang'a Loise L Ngoga Gedeon G Dusabeyezu Symaque S Hedt-Gauthier Bethany L BL Ngamije Patient P Habiyaremye Michel M Harerimana Emmanuel E Ndayisaba Gilles G Rusangwa Christian C Niyonsenga Simon Pierre SP Bavuma Charlotte M CM Bukhman Gene G Adler Alma J AJ Kateera Fredrick F Park Paul H PH

BMJ open 20200727 7

<h4>Introduction</h4>Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are n ...[more]

PMID: 32718924

Similar Datasets

Project description:BackgroundSIPsmartER is a 6-month evidenced-based, multi-component behavioral intervention that targets sugar-sweetened beverages among adults. It consists of three in-person group classes, one teach-back call, and 11 automated phone calls. Given SIPsmartER's previously demonstrated effectiveness, understanding its adoption, implementation, and potential for integration within a system that reaches health disparate communities is important to enhance its public health impact. During this pilot dissemination and implementation trial, SIPsmartER was delivered by trained staff from local health districts (delivery agents) in rural, Appalachian Virginia. SIPsmartER's execution was supported by consultee-centered implementation strategies.MethodsIn this mixed-methods process evaluation, adoption and implementation indicators of the program and its implementation strategy (e.g., fidelity, feasibility, appropriateness, acceptability) were measured using tracking logs, delivery agent surveys and interviews, and fidelity checklists. Quantitative data were analyzed with descriptive statistics. Qualitative data were inductively coded.ResultsDelivery agents implemented SIPsmartER to the expected number of cohorts (n?=?12), recruited 89% of cohorts, and taught 86% of expected small group classes with >?90% fidelity. The planned implementation strategies were also executed with high fidelity. Delivery agents completing the two-day training, pre-lesson meetings, fidelity checklists, and post-lesson meetings at rates of 86, 75, 100, and 100%, respectively. Additionally, delivery agents completed 5% (n?=?3 of 66) and 10% (n?=?6 of 59) of teach-back and missed class calls, respectively. On survey items using 6-point scales, delivery agents reported, on average, higher feasibility, appropriateness, and acceptability related to delivering the group classes (range 4.3 to 5.6) than executing missed class and teach-back calls (range 2.6 to 4.6). They also, on average, found the implementation strategy activities to be helpful (range 4.9 to 6.0). Delivery agents identified strengths and weakness related to recruitment, lesson delivery, call completion, and the implementation strategy.ConclusionsIn-person classes and the consultee-centered implementation strategies were viewed as acceptable, appropriate, and feasible and were executed with high fidelity. However, implementation outcomes for teach-back and missed class calls and recruitment were not as strong. Findings will inform the future full-scale dissemination and implementation of SIPsmartER, as well as other evidence-based interventions, into rural health districts as a means to improve population health.

Project description:BackgroundThe standard face-to-face training for the integrated management of childhood illness (IMCI) continues to be plagued by concerns of low coverage of trainees, the prolonged absence of trainees from the health facility to attend training and the high cost of training. Consequently, the distance learning IMCI training model is increasingly being promoted to address some of these challenges in resource-limited settings. This paper examines participants' accounts of the paper-based IMCI distance learning training programme in three district councils in Mbeya region, Tanzania.MethodsA cross-sectional qualitative descriptive design was employed as part of an endline evaluation study of the management of possible serious bacterial infection in Busokelo, Kyela and Mbarali district councils of Mbeya Region in Tanzania. Key informant interviews were conducted with purposefully selected policymakers, partners, programme managers and healthcare workers, including beneficiaries and training facilitators.ResultsAbout 60 key informant interviews were conducted, of which 53% of participants were healthcare workers, including nurses, clinicians and pharmacists, and 22% were healthcare administrators, including district medical officers, reproductive and child health coordinators and programme officers. The findings indicate that the distance learning IMCI training model (DIMCI) was designed to address concerns about the standard IMCI model by enhancing efficiency, increasing outputs and reducing training costs. DIMCI included a mix of brief face-to-face orientation sessions, several weeks of self-directed learning, group discussions and brief face-to-face review sessions with facilitators. The DIMCI course covered topics related to management of sick newborns, referral decisions and reporting with nurses and clinicians as the main beneficiaries of the training. The problems with DIMCI included technological challenges related to limited access to proper learning technology (e.g., computers) and unfriendly learning materials. Personal challenges included work-study-family demands, and design and coordination challenges, including low financial incentives, which contributed to participants defaulting, and limited mentorship and follow-up due to limited funding and transport.ConclusionDIMCI was implemented successfully in rural Tanzania. It facilitated the training of many healthcare workers at low cost and resulted in improved knowledge, competence and confidence among healthcare workers in managing sick newborns. However, technological, personal, and design and coordination challenges continue to face learners in rural areas; these will need to be addressed to maximize the success of DIMCI.

Project description:IntroductionPublished evaluations of sensor glucose monitoring use in insulin treated type 2 diabetes are limited. The aim of this study was to assess the impact of flash glucose-sensing technology as a replacement for self-monitoring of blood glucose (SMBG) over a 12-month period in participants with type 2 diabetes who were on intensive insulin therapy.MethodsAn open-label, randomized, controlled study in adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers aimed at assessing flash glucose sensing technology was conducted. Participants (N = 224) were randomized (1:2 respectively) to a control group (n = 75) that used SMBG (FreeStyle Lite™) or to an intervention group (n = 149) which used sensor glucose data (FreeStyle Libre™ Flash Glucose Monitoring System) for self-management over 6 months. All intervention group participants who completed the 6-month treatment phase continued into an additional 6-month open-access phase.ResultsA total of 139 intervention participants completed the 6-month treatment phase and continued into the open-access phase. At 12 months (end of open-access period), time in hypoglycemia [sensor glucose <3.9 mmol/L (70 mg/dL)] was reduced by 50% compared to baseline [-0.70 ± 1.85/24 h (mean ± standard deviation); p = 0.0002]. Nocturnal hypoglycemia [2300 to 0600 hours, <3.9 mmol/L (70 mg/dL)] was reduced by 52%; p = 0.0002. There was no change in time in range [sensor glucose 3.9-10.0 mmol/L (70-180 mg/dL)]. SMBG testing fell from a mean of 3.9 (median 3.9) times/day at baseline to 0.2 (0.0), with an average frequency of sensor scanning of 7.1 (5.7) times/day at 12 months, and mean sensor utilization was 83.6 ± 13.8% (median 88.3%) during the open-access phase. During this 6-month extension period no device-related serious adverse events were reported. Nine participants reported 16 instances of device-related adverse events (e.g. infection, allergy) and 28 participants (20.1%) experienced 134 occurrences of anticipated skin symptoms/sensor-insertion events expected with device use (e.g. erythema, itching and rash).ConclusionThe use of flash glucose-sensing technology for glycemic management in individuals with type 2 diabetes treated by intensive insulin therapy over 12 months was associated with a sustained reduction in hypoglycemia and safely and effectively replaced SMBG.Trial registrationClinicalTrials.gov identifier, NCT02082184.

Project description:INTRODUCTION:To address the know-do gap in the integration of mental health care into primary care in resource-limited settings, a multi-faceted implementation program initially designed to integrate HIV/AIDS care into primary care was adapted for severe mental disorders and epilepsy in Burera District, Rwanda. The Mentoring and Enhanced Supervision at Health Centers (MESH MH) program supported primary care-delivered mental health service delivery scale-up from 6 to 19 government-run health centers over two years. This quasi-experimental study assessed implementation reach, fidelity, and clinical outcomes at health centers supported by MESH MH during the scale up period. METHODS:MESH MH consisted of four strategies to ensure the delivery of the priority care packages at health centers: training; supervision and mentorship; audit and feedback; and systems-based quality improvement (QI). Implementation reach (service use) across the 19 health centers supported by MESH MH during the two year scale-up period was described using routine service data. Implementation fidelity was measured at four select health centers by comparing total clinical supervisory visits and checklists to target goals, and by tracking clinical observation checklist item completion rates over a nine month period. A prospective before and after evaluation measured clinical outcomes in consecutive adults presenting to four select health centers over a nine month period. Primary outcome assessments at baseline, 2 and 6 months included symptoms and functioning, measured by the General Health Questionnaire (GHQ-12) and the World Health Organization Disability Assessment Scale (WHO-DAS Brief), respectively. Secondary outcome assessments included engagement in income generating work and caregiver burden using a quantitative scale adapted to context. RESULTS:A total of 2239 mental health service users completed 15,744 visits during the scale up period. MESH MH facilitated 70% and 76% of supervisory visit and clinical checklist utilization target goals, respectively. Checklist item completion rates significantly improved overall, and for three of five checklist item subgroups examined. 121 of 146 consecutive service users completed outcome measurements six months after entry into care. Scores improved significantly over six months on both the GHQ-12, with median score improving from 26 to 10 (mean within-person change 12.5 [95% CI: 10.9-14.0] p< 0.0001), and the WHO-DAS Brief, with median score improving from 26.5 to 7 (mean within-person change 16.9 [95% CI: 14.9-18.8] p< 0.0001). Over the same period, the percentage of surveyed service users reporting an inability to work decreased significantly (51% to 6% (p < 0.001)), and the proportion of households reporting that a caregiver had left income-generating work decreased significantly (41% to 4% (p < 0.001)). CONCLUSION:MESH MH was associated with high service use, improvements in mental health care delivery by primary care nurses, and significant improvements in clinical symptoms and functional disability of service users receiving care at health centers supported by the program. Multifaceted implementation programs such as MESH MH can reduce the evidence to practice gap for mental health care delivery by nonspecialists in resource-limited settings. The primary limitation of this study is the lack of a control condition, consistent with the implementation science approach of the study. STUDY REGISTRATION:ISRCTN #37231.

Project description:BackgroundHyperglycaemia and hypoglycaemia are common in preterm infants and have been associated with increased risk of mortality and morbidity. Interventions to reduce risk associated with these exposures are particularly challenging due to the infrequent measurement of blood glucose concentrations, with the potential of causing more harm instead of improving outcomes for these infants. Continuous glucose monitoring (CGM) is widely used in adults and children with diabetes to improve glucose control, but has not been approved for use in neonates. The REACT trial aimed to evaluate the efficacy and safety of CGM in preterm infants requiring intensive care.MethodsThis international, open-label, randomised controlled trial was done in 13 neonatal intensive care units in the UK, Spain, and the Netherlands. Infants were included if they were within 24 h of birth, had a birthweight of 1200 g or less, had a gestational age up to 33 weeks plus 6 days, and had parental written informed consent. Infants were randomly assigned (1:1) to real-time CGM or standard care (with masked CGM for comparison) using a central web randomisation system, stratified by recruiting centre and gestational age (<26 or ≥26 weeks). The primary efficacy outcome was the proportion of time sensor glucose concentration was 2·6-10 mmol/L for the first week of life. Safety outcomes related to hypoglycaemia (glucose concentrations <2·6 mmol/L) in the first 7 days of life. All outcomes were assessed on the basis of intention to treat in the full analysis set with available data. The study is registered with the International Standard Randomised Control Trials Registry, ISRCTN12793535.FindingsBetween July 4, 2016, and Jan 27, 2019, 182 infants were enrolled, 180 of whom were randomly assigned (85 to real-time CGM, 95 to standard care). 70 infants in the real-time CGM intervention group and 85 in the standard care group had CGM data and were included in the primary analysis. Compared with infants in the standard care group, infants managed using CGM had more time in the 2·6-10 mmol/L glucose concentration target range (mean proportion of time 84% [SD 22] vs 94% [11]; adjusted mean difference 8·9% [95% CI 3·4-14·4]), equivalent to 13 h (95% CI 5-21). More infants in the standard care group were exposed to at least one episode of sensor glucose concentration of less than 2·6 mmol/L for more than 1 h than those in the intervention group (13 [15%] of 85 vs four [6%] of 70). There were no serious adverse events related to the use of the device or episodes of infection.InterpretationReal-time CGM can reduce exposure to prolonged or severe hyperglycaemia and hypoglycaemia. Further studies using CGM are required to determine optimal glucose targets, strategies to obtain them, and the potential effect on long-term health outcomes.FundingNational Institute for Health Research Efficacy and Mechanisms Evaluation Programme.

Project description:IntroductionMedical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.Methods and analysisThe study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.Trial registration numberClinicalTrials.gov Registry (NCT04331444).Protocol versionV.3, 11 December 2020.

Project description:IntroductionEvidence-based low-intensity psychological interventions such as Problem Management Plus (PM+) have the potential to expand treatment access for depression and anxiety, yet these interventions are not yet effectively implemented in rural, public health systems in resource-limited settings. In 2017, Partners In Health adapted PM+ for delivery by primary care nurses in rural Rwanda and began integrating PM+ into health centres in collaboration with the Rwandan Ministry of Health, using established implementation strategies for mental health integration into primary care (Mentoring and Enhanced Supervision at Health Centers for Mental Health (MESH MH)). A gap in the evidence regarding whether low-intensity psychological interventions can be successfully integrated into real-world primary care settings and improve outcomes for common mental disorders remains. In this study, we will rigorously evaluate the delivery of PM+ by primary care nurses, supported by MESH MH, as it is scaled across one rural district in Rwanda.Methods and analysisWe will conduct a hybrid type 1 effectiveness-implementation study to test the clinical outcomes of routinely delivered PM+ and to describe the implementation of PM+ at health centres. To study the clinical effectiveness of PM+, we will use a pragmatic, randomised multiple baseline design to determine whether participants experience improvement in depression symptoms (measured by the Patient Health Questionnaire-9) and functioning (measured by the WHO-Disability Assessment Scale Brief 2.0) after receiving PM+. We will employ quantitative and qualitative methods to describe and evaluate PM+ implementation outcomes using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, using routinely collected programme data and semistructured interviews.Ethics and disseminationThis evaluation was approved by the Rwanda National Ethics Committee (Protocol #196/RNEC/2019) and deemed exempt by the Harvard University Institutional Review Board. The results from this evaluation will be useful for health systems planners and policy-makers working to translate the evidence base for low-intensity psychological interventions into practice.

Project description:Aims/hypothesisThe aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes.MethodsChildren and adults (n = 153) on CSII with HbA(1c) 7.5-9.5% (58.5-80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months' washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA(1c) levels between arms after 6 months.ResultsSeventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA(1c) was -0.43% (-4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI -0.32%, -0.55% [-3.50, -6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA(1c) reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40).Conclusions/interpretationContinuous glucose monitoring was associated with decreased HbA(1c) levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.

Dataset Information

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.

Publications

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets