Glooko, Inc. has presented new real-world evidence suggesting that its EndoTool IV computerised insulin dosing system can support controlled maternal blood glucose levels during labour and delivery, with no recorded severe hypoglycaemia events among 267 evaluated patients. Announced on October 28, 2026, the findings were presented at a Diabetes Technology Society meeting and were drawn from 43 healthcare facilities using the FDA-cleared inpatient insulin management technology during 2025.
The retrospective analysis examined patients with Type 1 diabetes, Type 2 diabetes and gestational diabetes who required intravenous insulin while giving birth. According to Glooko, blood glucose measurements below 60 mg/dL occurred in 0.63% of readings among patients with Type 1 diabetes and 0.16% among those with Type 2 diabetes or gestational diabetes. Severe hypoglycaemia, defined in the analysis as blood glucose below 40 mg/dL, was not recorded in either group.
The findings provide evidence of glucose management performance in a specialised inpatient setting where insulin requirements can change rapidly. However, the study was observational and did not compare EndoTool IV with another insulin dosing protocol through randomisation. It also did not report neonatal outcomes, meaning that the results cannot establish whether the technology reduces newborn hypoglycaemia or improves broader maternal and infant health outcomes.
Why is computerised intravenous insulin dosing particularly important during labour and delivery for patients with diabetes?
Blood glucose management during labour and delivery presents a distinct clinical challenge because maternal insulin requirements can change over relatively short periods. Physical exertion, reduced oral intake, stress responses, intravenous fluids and changes in hormonal activity may all influence glucose concentrations. These factors require clinicians to adjust insulin administration while avoiding both excessive hyperglycaemia and treatment-related hypoglycaemia.
Patients with Type 1 diabetes may require continuous insulin availability to prevent serious metabolic complications, even when food intake is limited. Patients with gestational diabetes or Type 2 diabetes may have different insulin requirements depending on their previous treatment, glycaemic control and clinical circumstances. A single fixed dosing approach may therefore be unsuitable for every patient.
Hospital teams commonly rely on structured protocols and frequent blood glucose measurements to manage intravenous insulin infusions. These protocols can be effective, but they require accurate interpretation and timely dose adjustments. A computerised decision-support system may help standardise calculations and incorporate patient-specific information into dosing recommendations.
Glooko’s EndoTool IV is designed to support this process by generating individualised intravenous insulin dosing recommendations for clinicians. The software is intended to assist healthcare professionals rather than independently administer treatment without oversight. Its usefulness depends on the accuracy of blood glucose measurements, the quality of patient information and the clinical team’s response to recommendations.
The labour and delivery setting provides an important test of this approach because insulin needs can shift quickly. However, evidence of accurate glucose control during hospitalisation must be distinguished from evidence that a particular system improves patient outcomes compared with established protocols.
What did the 267-patient EndoTool IV analysis reveal about hypoglycaemia and hyperglycaemia during childbirth?
The study, titled Use of a Computerized Intravenous Insulin Dosing Application in Pregnancy, examined information from the 2025 EndoTool IV database. Researchers included 267 patients across 43 facilities and assessed glucose measurements recorded during intravenous insulin treatment. The analysis compared patients with Type 1 diabetes against a combined group consisting of individuals with Type 2 diabetes and gestational diabetes.
Glooko reported no recorded blood glucose values below 40 mg/dL in either group. This threshold was used to define severe hypoglycaemia within the analysis, although clinical definitions of severe hypoglycaemia can also consider whether a patient required assistance from another person. The absence of recorded values below this threshold is encouraging but does not establish that serious hypoglycaemia cannot occur with the system.
Less severe low-glucose measurements were uncommon. Blood glucose below 60 mg/dL occurred in 0.63% of readings among patients with Type 1 diabetes and 0.16% among those with Type 2 diabetes or gestational diabetes. These percentages describe glucose readings rather than the proportion of patients who experienced an episode.
Hyperglycaemia was also relatively uncommon under the reported measurement framework. Values above 180 mg/dL accounted for less than 10% of readings in either group, while only six total readings exceeded 300 mg/dL. The results suggest that the evaluated facilities generally achieved glucose management without frequent extreme measurements.
Glooko further reported that the treatment approach maintained the specified 90 to 120 mg/dL range in approximately 80% to 90% of patients. However, the announcement did not provide the detailed calculation used to derive this measure, including whether it represented time within range or another patient-level performance criterion. That distinction limits comparisons with studies reporting conventional time-in-range percentages.
How should the absence of severe hypoglycaemia be interpreted in a retrospective real-world study?
The absence of recorded severe hypoglycaemia is an important observation, particularly in patients receiving intravenous insulin. However, a sample of 267 individuals is not large enough to exclude the possibility of rare adverse events. The finding should therefore be interpreted as describing the observed study population rather than establishing an absolute safety guarantee.
Retrospective database research also depends on the completeness and quality of recorded information. Glucose measurements may not capture every clinically relevant episode if testing intervals vary or information is missing. The announcement does not provide sufficient detail about data completeness, monitoring frequency or the methods used to identify potentially unrecorded events.
Another limitation is the lack of a concurrent comparator group. Without comparing patients managed through EndoTool IV against those receiving conventional protocols under similar conditions, the study cannot determine how much of the observed performance is attributable to the software. Differences in clinical staffing, patient selection and local hospital practices may influence outcomes.
The combination of data from 43 facilities increases the range of clinical environments represented in the analysis. Nevertheless, it also introduces possible variation in implementation, glucose monitoring and local treatment protocols. Detailed site-level information would help determine whether the findings were consistent across hospitals or concentrated in particular settings.
The results support the feasibility of using EndoTool IV in a real-world obstetric population, but they do not establish superiority over other insulin management approaches. A prospective comparative study would provide stronger evidence of whether the software reduces hypoglycaemia, improves time within target or changes clinically meaningful outcomes.
Why does maternal glucose control during delivery matter for newborn hypoglycaemia risk?
Maternal glucose concentrations around the time of birth can influence the newborn’s metabolic adaptation after delivery. Elevated maternal glucose may stimulate fetal insulin production, potentially contributing to low neonatal blood glucose after the maternal glucose supply is interrupted. This relationship provides a rationale for monitoring and managing maternal glucose during labour.
However, the association between maternal glucose control and neonatal outcomes is more complex than simply assuming that tighter control always produces better results. Excessively intensive insulin treatment can increase maternal hypoglycaemia risk, while neonatal glucose outcomes may be influenced by other maternal and infant characteristics. Clinical protocols therefore seek an appropriate balance rather than the lowest achievable maternal glucose concentration.
The EndoTool IV announcement reports maternal glucose measurements but does not provide neonatal hypoglycaemia rates, neonatal intensive care admissions or other infant outcomes. Consequently, the study cannot establish that the software improves newborn metabolic health. Its findings are limited to the maternal glucose management measures disclosed.
This distinction is important because the commercial and clinical value of an obstetric insulin management system may depend partly on outcomes extending beyond maternal laboratory measurements. Hospitals evaluating the technology will want to understand whether improved dosing consistency is associated with better maternal safety, fewer neonatal complications or reduced clinical workload. Those questions require additional evidence.
The current findings therefore provide a foundation for further research rather than a definitive demonstration of perinatal benefit. EndoTool IV may support clinically appropriate glucose management, but the effect of its use on newborn outcomes remains unresolved within the reported dataset.
How do the EndoTool IV findings compare with research questioning very strict intrapartum glucose targets?
The appropriate glucose target during labour has been an area of ongoing clinical investigation. Some conventional protocols have aimed for relatively narrow maternal glucose ranges, while newer studies have examined whether more permissive targets produce comparable neonatal outcomes. The underlying question is whether tighter maternal control offers sufficient additional benefit to justify the potential for more intensive insulin treatment.
The PERMIT randomised controlled trial, published in the American Journal of Obstetrics and Gynecology in 2024, compared usual intrapartum glucose management targeting 70 to 110 mg/dL with a more permissive strategy targeting 70 to 180 mg/dL. The study included 96 participants with pregestational or gestational diabetes. Its primary outcome was the newborn’s first measured blood glucose concentration following delivery.
The trial reported mean first neonatal glucose values of 57.9 mg/dL in the usual-care group and 57.1 mg/dL in the permissive group. Neonatal hypoglycaemia occurred in 25% and 29% of newborns, respectively, without a statistically established difference between the strategies. The investigators concluded that the more permissive approach produced equivalent neonatal glucose outcomes under the study’s predefined criteria.
These findings do not establish that strict glucose targets are unnecessary in every clinical circumstance. The trial was relatively small, and management requirements differ between patients with Type 1 diabetes and those with other forms of diabetes. Nevertheless, the results demonstrate why maintaining a narrow glucose range should not automatically be treated as proof of superior neonatal care.
For Glooko, this research provides important context for interpreting the EndoTool IV analysis. The reported ability to maintain relatively tight maternal glucose levels is a useful technical and clinical observation, but its significance depends on whether that level of control is necessary and beneficial for the patient population being treated. Future studies could examine whether individualised targets improve the balance between maternal safety, neonatal outcomes and treatment burden.
How does EndoTool IV generate personalised insulin dosing recommendations in hospital settings?
EndoTool IV is a computerised clinical decision-support system designed to assist with intravenous insulin administration in hospitalised patients. It uses patient-specific information and glucose measurements to calculate recommended insulin dosing adjustments. The objective is to help clinicians manage changing insulin requirements through a structured algorithm rather than relying exclusively on fixed protocols.
The system is classified as an FDA-cleared Class II medical device for inpatient use. Its recommendations are intended to support healthcare professional judgement, and the software is not a substitute for clinical assessment. The October labour and delivery findings represent an evaluation of its use in an obstetric care setting, not a new FDA approval or an expansion of the device’s authorised indication.
Personalised dosing may be useful because insulin sensitivity varies substantially between patients and can change during acute medical care. An algorithm capable of incorporating successive glucose measurements may help standardise how clinicians respond to these changes. However, the effectiveness of the approach depends on the accuracy and timeliness of the underlying measurements.
Operational integration is another important consideration. The system must fit within the hospital’s medication administration processes, glucose monitoring procedures and electronic documentation workflows. Nurses and physicians also need appropriate training to interpret recommendations and recognise circumstances requiring clinical intervention.
The study’s findings suggest that EndoTool IV can be used across multiple hospital facilities during labour and delivery. Nevertheless, the announcement does not provide a detailed evaluation of staff workload, medication errors, time required for dosing decisions or user satisfaction. These measures could become important when hospitals assess the technology’s operational value.
What does FDA clearance for EndoTool IV Cloud mean for Glooko’s inpatient diabetes technology strategy?
Glooko expanded its inpatient technology portfolio in May 2026 when the FDA granted 510(k) clearance for EndoTool IV Cloud. The cloud-based system uses the same core insulin dosing algorithm as the existing EndoTool IV solution while introducing a different technical deployment architecture. The clearance is recorded under FDA 510(k) number K260910, with the agency’s decision dated May 1, 2026.
The cloud architecture is intended to support more scalable implementation and reduce dependence on locally maintained infrastructure. Centralised software management may offer practical advantages for healthcare organisations operating multiple facilities. However, the operational benefits depend on successful implementation, cybersecurity controls and reliable connectivity.
Glooko had indicated that commercial launch of EndoTool IV Cloud was anticipated before the end of 2026. The October labour and delivery analysis should not be interpreted as clinical evidence generated using the newer cloud product. The reported data came from the 2025 EndoTool IV database and therefore predated the cloud clearance.
This distinction is important because regulatory clearance of a new deployment configuration does not automatically establish improved clinical outcomes. The cloud platform may incorporate the same underlying dosing algorithm, but its practical performance will still depend on the clinical environment and implementation. Healthcare providers will need to assess whether the newer architecture offers meaningful operational improvements.
For Glooko, the combination of established inpatient dosing technology and a cloud-based platform creates an opportunity to expand hospital relationships. The commercial implications will depend on purchasing decisions, transition arrangements for existing customers and evidence that the technology supports reliable care across different hospital departments.
How could GestationalCare and EndoTool IV support a more connected approach to diabetes management during pregnancy?
Glooko has also expanded its ambulatory diabetes management platform through GestationalCare, a pregnancy-specific module designed to support outpatient glucose monitoring and clinical coordination. The company announced the module in September 2026 and subsequently confirmed its availability in the United States. The technology is intended to help healthcare teams review glucose patterns during pregnancy and identify patients who may require additional clinical attention.
Diabetes management during pregnancy often involves several professional groups, including obstetricians, endocrinologists, diabetes educators and maternal-fetal medicine specialists. These teams may rely on different systems and information sources when assessing patients. Fragmented communication can complicate treatment adjustments, particularly when glucose requirements change during pregnancy.
GestationalCare is designed to support the outpatient component of this process, including evaluation of fasting and post-meal glucose measurements. EndoTool IV addresses a different requirement by supporting intravenous insulin dosing during inpatient care. Together, the technologies give Glooko a broader product portfolio spanning different stages of pregnancy-related diabetes management.
However, the existence of two products within the same portfolio does not establish seamless integration between them. The company has not disclosed evidence demonstrating that GestationalCare and EndoTool IV together improve clinical outcomes compared with separate management systems. Their combined value will depend on interoperability, workflow coordination and the quality of information shared between care teams.
The postpartum transition introduces another important consideration because insulin requirements may change substantially after delivery. Continuing diabetes care may involve different treatment decisions depending on whether the patient has Type 1 diabetes, Type 2 diabetes or gestational diabetes. A connected platform could potentially support these transitions, but its effectiveness must be evaluated through actual clinical use.
What evidence will hospitals need before expanding EndoTool IV use across labour and delivery departments?
Hospitals considering broader use of EndoTool IV will need to assess both clinical outcomes and implementation requirements. The latest study provides descriptive evidence of glucose management among patients already receiving the technology. However, prospective comparisons would be useful for determining whether algorithm-assisted dosing offers measurable advantages over established local protocols.
A future study could compare maternal hypoglycaemia, hyperglycaemia, time within appropriate targets and insulin infusion adjustments between different dosing approaches. It could also assess neonatal glucose outcomes, treatment interruptions and other clinically relevant measures. These outcomes would help establish whether the system contributes benefits beyond the glucose measurements already reported.
Patient subgroup analysis would be particularly important because Type 1 diabetes differs substantially from gestational diabetes and Type 2 diabetes in its insulin management requirements. The combined analysis of gestational diabetes and Type 2 diabetes in the October study provides useful descriptive information but may obscure differences between these populations. Future research with larger subgroup samples could clarify whether performance is consistent across different forms of diabetes.
Hospitals will also evaluate the resources required to deploy and maintain the system. Software licensing, staff training, integration with existing hospital systems and technical support can influence the total cost of implementation. The October announcement did not disclose comparative operating costs or direct evidence of reduced staff workload.
Clinical safety governance will remain central to adoption. EndoTool IV provides recommendations that require appropriate professional oversight, and hospitals must ensure that staff can identify unexpected glucose changes or circumstances requiring deviation from algorithmic guidance. Reliable use will depend on both the software and the surrounding clinical processes.
What do the Diabetes Technology Society findings mean for Glooko’s broader commercial strategy?
Glooko’s latest evidence supports its effort to position diabetes management as a connected process spanning outpatient monitoring, hospital treatment and follow-up care. The company expanded its inpatient capabilities following the acquisition of Monarch Medical Technologies in September 2025, bringing EndoTool into a portfolio already focused on diabetes data management. Subsequent development of EndoTool IV Cloud and GestationalCare has broadened its technology offering.
The commercial opportunity lies in providing healthcare organisations with tools addressing different stages of diabetes care. Hospitals managing complex insulin requirements may value computerised dosing support, while outpatient practices may prioritise longitudinal glucose monitoring and patient engagement. A broader platform could potentially support both settings, although purchasing decisions and technical integration requirements differ.
The October 2026 labour and delivery analysis provides a specific example of EndoTool IV being used outside a general inpatient diabetes population. That could support further discussions with hospital systems interested in standardising glucose management across departments. However, Glooko has not disclosed new contracts, additional revenue or hospital purchasing commitments arising from the study.
The company’s current evidence should therefore be interpreted as supporting clinical and commercial evaluation rather than establishing immediate financial benefits. Continued growth will depend on demonstrating that its products offer measurable advantages in patient outcomes, workflow reliability or the cost of care. Regulatory clearance and favourable observational findings provide important foundations but do not guarantee rapid adoption.
For the labour and delivery application, the next meaningful evidence will need to extend beyond maternal glucose control. A prospective study incorporating neonatal outcomes, appropriate comparison groups and operational measures would provide stronger support for wider implementation. Such research could clarify whether the system’s personalised dosing recommendations improve care in a setting where both excessive and inadequate insulin treatment carry potential consequences.
The absence of recorded severe hypoglycaemia among 267 patients is encouraging, particularly given the dynamic nature of insulin requirements during childbirth. Nevertheless, the retrospective design, lack of a comparator and absence of neonatal outcome data prevent broader conclusions about clinical superiority. Glooko’s next opportunity is to demonstrate that EndoTool IV can deliver reproducible benefits across different hospitals while supporting safe, clinically appropriate maternal and newborn care.
