Daily Endocrinology Research Analysis
Three high-impact studies in endocrinology and metabolism stood out: an inpatient randomized trial showed continuous glucose monitoring (CGM)-guided insulin titration markedly improves glycemia and reduces complications; a prespecified postpartum extension of a randomized trial supports sustained benefits of hybrid closed-loop automated insulin delivery in type 1 diabetes; and a prospective multicenter study in diabetology validates practical two-step algorithms (FIB-4 with elastography) to scre
Summary
Three high-impact studies in endocrinology and metabolism stood out: an inpatient randomized trial showed continuous glucose monitoring (CGM)-guided insulin titration markedly improves glycemia and reduces complications; a prespecified postpartum extension of a randomized trial supports sustained benefits of hybrid closed-loop automated insulin delivery in type 1 diabetes; and a prospective multicenter study in diabetology validates practical two-step algorithms (FIB-4 with elastography) to screen for MASLD-related advanced fibrosis.
Research Themes
- Inpatient CGM-guided insulin titration improves outcomes
- Automated insulin delivery postpartum in type 1 diabetes
- Diabetology-led screening algorithms for MASLD-related advanced fibrosis
Selected Articles
1. In-Hospital Diabetes Management by a Diabetes Team and Insulin Titration Algorithms Based on Continuous Glucose Monitoring or Point-of-Care Glucose Testing in Patients With Type 2 Diabetes (DIATEC): A Randomized Controlled Trial.
In this two-center randomized trial of 166 hospitalized adults with type 2 diabetes, CGM-guided insulin titration increased time-in-range by 15 percentage points versus point-of-care guidance, and reduced time above range, time below range, glycemic variability, prolonged hypoglycemia, insulin dose, and a composite of complications. The findings support CGM-guided protocols for inpatient diabetes management.
Impact: High-quality RCT evidence shows CGM-guided inpatient insulin titration improves multiple clinically meaningful outcomes and reduces complications, likely changing hospital protocols.
Clinical Implications: Hospitals should consider implementing CGM-based insulin titration algorithms for non-ICU inpatients with type 2 diabetes, supported by diabetes teams, to improve glycemic control and reduce complications and insulin requirements.
Key Findings
- CGM arm achieved higher median TIR: 77.6% vs 62.7% (P<0.001).
- Time above range >10.0 mmol/L was lower with CGM: 21.1% vs 36.5% (P=0.001).
- Time below range <3.9 mmol/L reduced with CGM (relative difference 0.57; 95% CI 0.34-0.97; P=0.042) and prolonged hypoglycemia events decreased (IRR 0.13; P=0.001).
- Glycemic variability (coefficient of variation) was lower with CGM: 25.4% vs 28.0% (P=0.024).
- Total daily insulin dose was reduced (24.1 vs 29.3 IU/day; P=0.049), and composite in-hospital complications were lower (IRR 0.76; P=0.032).
Methodological Strengths
- Randomized controlled, two-center design with algorithm-guided insulin titration.
- Comprehensive CGM metrics (TIR, TAR, TBR), variability, hypoglycemia events, insulin dose, and complications assessed during hospitalization.
Limitations
- Conducted in non-ICU settings at two centers; generalizability to ICU or different hospital systems may be limited.
- Short assessment window restricted to hospitalization; no post-discharge outcomes reported.
Future Directions: Evaluate scalability, cost-effectiveness, and implementation strategies for CGM-guided inpatient insulin titration across diverse hospital systems, including ICU settings and post-discharge outcomes.
OBJECTIVE: The Diabetes Team and CGM in Managing Hospitalized Patients With Diabetes (DIATEC) trial investigates the glycemic and clinical effects of inpatient continuous glucose monitoring (CGM)-guided insulin titration by diabetes teams. RESEARCH DESIGN AND METHODS: This two-center trial randomized 166 non-intensive care unit patients with type 2 diabetes. Diabetes management was performed by regular staff, guided by diabetes teams using insulin titration algorithms based on either point-of-care glucose testing or CGM. The primary outcome was the difference in time in range (TIR) (3.9-10.0 mmol/L) between the two arms. Outcomes were assessed during hospitalization. RESULTS: The CGM arm achieved a higher median (interquartile range [IQR]) TIR of 77.6% (24.4%) vs. 62.7% (31.5%) in the POC arm (P < 0.001). Median (IQR) time above range (TAR) >10.0 mmol/L was lower in the CGM arm at 21.1% (24.8%) vs. 36.5% (30.3%) in the POC arm (P = 0.001), and time below range (TBR) <3.9 mmol/L was reduced by CGM, with a relative difference to POC of 0.57 (95% CI 0.34-0.97; P = 0.042). Prolonged hypoglycemic events decreased (incidence rate ratio [IRR] 0.13; 95% CI 0.04-0.46; P = 0.001), and the mean (SD) coefficient of variation was lower in the CGM arm at 25.4% (6.3%) vs. 28.0% (8.2%) in the POC arm (P = 0.024). Mean (SD) total insulin doses were reduced in the CGM arm at 24.1 (13.9) vs. 29.3 (13.9) IU/day in the POC arm (P = 0.049). A composite of complications was lower in the CGM arm (IRR 0.76; 95% CI 0.59-0.98; P = 0.032). CONCLUSIONS: In-hospital CGM increased TIR by 15 percentage points, mainly by reducing TAR. CGM also lowered TBR, glycemic variability, prolonged hypoglycemic events, insulin usage, and in-hospital complications.
2. Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study.
This prespecified extension of a multicenter RCT followed 57 women with type 1 diabetes for 6 months postpartum. Hybrid closed-loop automated insulin delivery maintained approximately 70% time-in-range compared with standard therapy plus CGM, supporting continued postpartum use.
Impact: Addresses a major evidence gap for postpartum glycemic management in type 1 diabetes with randomized data in a high-impact setting.
Clinical Implications: Postpartum individuals with type 1 diabetes who used HCL during pregnancy can safely continue hybrid closed-loop therapy to sustain near-target glycemia during the first 6 months after delivery.
Key Findings
- In the postpartum extension (n=57), the HCL group maintained approximately 70% time-in-range over 6 months.
- Randomized allocation from the original trial was preserved, comparing HCL vs standard insulin therapy with CGM.
- Primary endpoint assessed TIR at 0–3 months, 3–6 months, and cumulatively over 6 months postpartum.
Methodological Strengths
- Prespecified extension of a multicenter randomized controlled trial with site-stratified randomization.
- Use of standardized CGM metrics (TIR 3.9–10.0 mmol/L) across predefined postpartum intervals.
Limitations
- Modest postpartum sample size (n=57) with eligibility constraints may limit generalizability.
- Abstract does not report detailed secondary outcomes (e.g., hypoglycemia, patient-reported outcomes).
Future Directions: Assess maternal-infant outcomes, lactation-related factors, hypoglycemia burden, usability, and cost-effectiveness of postpartum hybrid closed-loop use in larger and more diverse populations.
BACKGROUND: Clinical guidelines in the UK and elsewhere do not specifically address hybrid closed loop (HCL) use in the postpartum period when the demands of caring for a newborn are paramount. Our aim was to evaluate the safety and efficacy of HCL use during the first 6 months postpartum compared with standard care. METHODS: In this prespecified extension to a multicentre, randomised controlled trial, pregnant women with type 1 diabetes at nine UK sites were followed up for 6 months postpartum. Eligible participants (AiDAPT participants recruited after the implementation of the postpartum protocol amendment approval, those still pregnant or within six months of delivery at the time of amendment implementation and still using HCL or continuous glucose monitoring [CGM] therapy) continued their randomly assigned treatment, either standard insulin therapy with CGM or HCL therapy (CamAPS FX system version 0.3.1, CamDiab, Cambridge, UK). Participants were randomised in a 1:1 ratio with stratification by clinical site using randomly permuted block sizes of 2 or 4. The primary outcome was the between-group difference in percentage time in range ([TIR] 3·9-10·0 mmol/L [70-180mg/dL]), measured during the periods of month 0 up to 3, months 3 to 6, and over 6 months postpartum. The study is registered at ClinicalTrials.gov (ISRCTN56898625) and is complete. FINDINGS: Of the 124 AiDAPT trial participants, 66 (53%) were ineligible for inclusion in the postpartum extension, and 57 participants consented to continue their treatment per original random allocation. The mean age was 31 years (SD 4), and all participants had early pregnancy HbA INTERPRETATION: Participants in the HCL group maintained 70% TIR during the first 6 months postpartum, supporting continued use of HCL rather than standard insulin therapy for people with diabetes once they have given birth. FUNDING: National Institute for Health Research, Juvenile Diabetes Research Foundation, and Diabetes Research & Wellness Foundation. CGM devices were provided by Dexcom at a discounted price.
3. Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease-Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study.
In 654 patients with MASLD and type 2 diabetes and/or obesity, noninvasive algorithms using FIB-4 followed by VCTE (or 2D-SWE/ELF) performed well for triaging advanced fibrosis. FIB-4/VCTE showed excellent diagnostic performance for referral; FIB-4/ELF at 9.8 offered high NPV but lower PPV, supporting practical screening pathways in diabetology clinics.
Impact: Provides prospective multicenter evidence to operationalize MASLD advanced fibrosis screening in diabetology using accessible tools (FIB-4, VCTE/ELF), addressing a major care gap.
Clinical Implications: Diabetology clinics can adopt a two-step screening algorithm—FIB-4 followed by VCTE where available, or ELF/2D-SWE—to efficiently triage patients for hepatology referral, leveraging high NPV to rule out advanced fibrosis.
Key Findings
- Among 654 patients, 17.6% had intermediate/high risk and 9.3% had high risk of advanced fibrosis.
- Diagnostic AUCs for high-risk AF: FIB-4 0.78, FibroTest 0.78, FibroMeter 0.74, ELF 0.82, SWE 0.84.
- FIB-4/VCTE algorithms showed strong performance for referral decisions; FIB-4/ELF (threshold 9.8) achieved NPV 88–89% with PPV 39–46%; FIB-4/2D-SWE achieved NPV 91% with PPV 58–62%.
- Age-adapted FIB-4 thresholds reduced NPV and PPV across algorithms.
Methodological Strengths
- Prospective multicenter design with comprehensive liver phenotyping and composite reference (biopsy, MRE, or VCTE ≥12 kPa).
- Direct head-to-head comparison of multiple NITs and pragmatic two-step algorithms relevant to diabetology workflows.
Limitations
- Interim analysis; not all participants had biopsy, and composite reference may introduce heterogeneity.
- Conducted in specialized settings; real-world performance in primary care or resource-limited clinics warrants evaluation.
Future Directions: Validate algorithm performance and thresholds across diverse populations and care settings, assess outcomes of referral strategies, and integrate with diabetes care pathways and EHR-based prompts.
OBJECTIVE: Screening for advanced fibrosis (AF) resulting from metabolic dysfunction-associated steatotic liver disease (MASLD) is recommended in diabetology. This study aimed to compare the performance of noninvasive tests (NITs) with that of two-step algorithms for detecting patients at high risk of AF requiring referral to hepatologists. RESEARCH DESIGN AND METHODS: We conducted a planned interim analysis of a prospective multicenter study including participants with type 2 diabetes and/or obesity and MASLD with comprehensive liver assessment comprising blood-based NITs, vibration-controlled transient elastography (VCTE), and two-dimensional shear-wave elastography (2D-SWE). AF risk stratification was determined by a composite criterion of liver biopsy, magnetic resonance elastography, or VCTE ≥12 kPa depending on availability. RESULTS: Of 654 patients (87% with type 2 diabetes, 56% male, 74% with obesity), 17.6% had an intermediate/high risk of AF, and 9.3% had a high risk of AF. The area under the empirical receiver operating characteristic curves of NITs for detection of high risk of AF were as follows: fibrosis-4 index (FIB-4) score, 0.78 (95% CI 0.72-0.84); FibroMeter, 0.74 (0.66-0.83); FibroTest, 0.78 (0.72-0.85); Enhanced Liver Fibrosis (ELF) test, 0.82 (0.76-0.87); and SWE, 0.84 (0.78-0.89). Algorithms with FIB-4 score/VCTE showed good diagnostic performance for referral of patients at intermediate/high risk of AF to specialized care in hepatology. An alternative FIB-4 score/ELF test strategy showed a high negative predictive value (NPV; 88-89%) and a lower positive predictive value (PPV; 39-46%) at a threshold of 9.8. The FIB-4 score/2D-SWE strategy had an NPV of 91% and a PPV of 58-62%. The age-adapted FIB-4 score threshold resulted in lower NPVs and PPVs in all algorithms. CONCLUSIONS: The FIB-4 score/VCTE algorithm showed excellent diagnostic performance, demonstrating its applicability for routine screening in diabetology. The ELF test using an adapted low threshold at 9.8 may be used as an alternative to VCTE.