BACKGROUND
Humanitarian crises bring unique, and potentially growing challenges to people with type 1 diabetes (T1D). We aimed to determine, in youth with T1D (mean age (± 1SD) 0–17.9 years) within and coming from humanitarian crises settings (HCS), the reported prevalence that meet international consensus targets for glycaemic, blood pressure and lipid management, and incidence of severe hypoglycaemia or diabetic ketoacidosis.
METHODS
A narrative review of quantitative data was conducted, using a systematic process. MEDLINE (Ovid), Global Health, Web of Science, Scopus, Embase, CINAHL, APA PsycINFO, Cochrane trials, and the reference lists of eligible records were searched (January 2014-February 2024); ten records covering ten separate studies were retrieved.
RESULTS
Glycaemic management was consistently suboptimal in HCS. However, among individuals coming from HCS, glycaemia varied. Across both groups, data relating to blood pressure, lipids, severe hypoglycaemia or diabetic ketoacidosis were either unavailable or limited.
CONCLUSION
Findings expose the dearth of data relating to defined youth with T1D within and coming from HCS, leaving the status of this population largely uncharacterised. With limited data indicating suboptimal T1D management, there is a pressing need for the development of a consensus guideline on, and core indicators relating to such youth within and coming from HCS, plus monitoring systems and outcome data.
AIMS
Most glucose self-monitoring devices have been developed with high-income countries in mind. We developed a target product profile (TPP) for new glucose self-monitoring technologies for users in low- and middle-income countries (LMICs).
METHODS
A draft TPP including 39 characteristics was developed by an expert group including diabetes specialists, device specialists, and people with diabetes, incorporating findings from qualitative research in LMICs. Each characteristic had minimal and optimal requirements for two use cases, frequent and sporadic use. Characteristics requiring refinement were identified via online survey. Characteristics with agreement level <90% for any requirement were reviewed by the expert group and amended as appropriate.
RESULTS
One characteristic (shelf life) had agreement <75% (both requirements for both use cases). Characteristics with agreement ≥75% and <90% for the frequent use case included infrastructure level, measurement cycle, duration of use before replacement, interchangeability, and calibration (both requirements), and activity log and price per month to end payer (minimal requirement). Intended use (both requirements), accuracy, and price per month to end payer (optimal requirement) had agreement ≥75% and <90% for the sporadic use case.
CONCLUSIONS
This TPP will inform developers on requirements for glucose self-monitoring technologies for LMICs, and support decision-makers in evaluating existing devices.
endTB is a Phase 3, randomized, controlled, non-inferiority trial, comparing five 9-month experimental regimens consisting of 4-5 drugs (including bedaquiline, delamanid, clofazimine, linezolid, fluoroquinolones, and pyrazinamide) to the standard of care for rifampicin-resistant, fluoroquinolone-susceptible tuberculosis. Three experimental regimens (endTB1, endTB2, endTB3) were non-inferior to the control in the primary analysis. This analysis explores the efficacy results of the endTB clinical trial in key subgroups (HIV positive, low BMI, diabetes, severe disease) to help clinicians to make the choice between these three regimens for patients with a more difficult to treat form of disease.
METHODS
For each subgroup, proportion of favourable outcome at Week 73 was calculated in each arm. Risk differences and 95% confidence intervals were estimated in the modified intention-to-treat population (mITT), which included all randomized participants who took at least one dose of study treatment and had a positive pre-randomization tuberculosis culture. Results in each arm were plotted on forest plots.
RESULTS
In HIV-infected patients, efficacy results are consistent with the overall results in endTB1 and endTB2 while in endTB3 the effect of trt favours the control arm. No differences from the overall population were observed in any of the 3 arms in patients with a more severe disease, while treatment effect in patients with low BMI, favours the control arm in all 3 arms. Treatment effect in patients with diabetes, favours the experimental arm in all 3 arms.
CONCLUSION
All 3 arms could reasonably be used in patients with severe disease or diabetes. endTB1 and endTB2 appeared to be particularly efficacious in HIV positive patients. Longer or regimens with more drugs may achieve better results in patients with low BMI. Additional research is needed to confirm these findings.
The burden of diabetes is growing worldwide. The costs associated with diabetes put substantial pressure on patients and health budgets, especially in low- and middle-income countries. The prices of diabetes medicines are a key determinant for access, yet little is known about the association between manufacturing costs and current market prices.
OBJECTIVES
To estimate the cost of manufacturing insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagonlike peptide 1 agonists (GLP1As), derive sustainable cost-based prices (CBPs), and compare these with current market prices.
DESIGN, SETTING, AND PARTICIPANTS
In this economic evaluation, the cost of manufacturing insulins, SGLT2Is, and GLP1As was modeled. Active pharmaceutical ingredient cost per unit (weighted least-squares regression model using data from a commercial database of trade shipments, data from January 1, 2016, to March 31, 2023) was combined with costs of formulation and other operating expenses, plus a profit margin with an allowance for tax, to estimate CBPs. Cost-based prices were compared with current prices in 13 countries, collected in January 2023 from public databases. Countries were selected to provide representation of different income levels and geographic regions based on the availability of public databases.
MAIN OUTCOMES AND MEASURES
Estimated CBPs; lowest current market prices (2023 US dollars).
RESULTS
In this economic evaluation of manufacturing costs, estimated CBPs for treatment with insulin in a reusable pen device could be as low as $96 (human insulin) or $111 (insulin analogues) per year for a basal-bolus regimen, $61 per year using twice-daily injections of mixed human insulin, and $50 (human insulin) or $72 (insulin analogues) per year for a once-daily basal insulin injection (for type 2 diabetes), including the cost of injection devices and needles. Cost-based prices ranged from $1.30 to $3.45 per month for SGLT2Is (except canagliflozin: $25.00-$46.79) and from $0.75 to $72.49 per month for GLP1As. These CBPs were substantially lower than current prices in the 13 countries surveyed.
CONCLUSIONS AND RELEVANCE
High prices limit access to newer diabetes medicines in many countries. The findings of this study suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally.
Tuberculosis (TB) among hospitalized patients is underdiagnosed. This study assessed systematic TB-screening, followed by an enhanced TB-diagnostic package for hospitalized patients implemented by trained lay health workers in KwaZulu-Natal, South Africa.
METHODS
In this before-and-after study we included patients ≥ 18 years. The intervention consisted of systematic clinical screening for TB, HIV and diabetes mellitus by lay health workers and provision of an enhanced TB-diagnostic package including sputum Xpert MTB/Rif Ultra, urine lateral-flow lipoarabinomannan assay (LF-LAM), chest x-ray, and sputum culture. We compared TB case findings with people hospitalized one year preceding the intervention.
RESULTS
In the pre-intervention phase, 5217 people were hospitalized. Among 4913 (94.2%) people not on TB treatment, 367 (7.5%) were diagnosed with TB. In the intervention phase, 4015 eligible people were hospitalized. Among 3734 (93.0%) people not on TB treatment, 560 (15.0%) were diagnosed with TB. The proportion of patients diagnosed with TB was higher in the intervention phase (15.0% vs. 7.5%, p < 0.001). Overall in-hospital mortality was lower in the intervention phase [166/3734(4.5%) vs. 336/4913(6.8%), p < 0.001].
CONCLUSION
Lay health worker-led implementation of systematic TB-screening, coupled with provision of an enhanced TB-diagnostic package significantly improved TB case detection and mortality among hospitalized adults.
