Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study

Conget, Ignacio; Mangas, Miguel Angel; Morales, Cristóbal; Caro, Juan; Giménez, Margarita; Borrell, Mireia; Delgado, Elías

doi:10.1007/s13300-021-01153-4

Cited by 14 publications

(21 citation statements)

References 40 publications

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“…However, the findings of the current study were in line with the results of some recent studies comparing the TDD between patients using insulin glargine 300 U/mL and those using insulin degludec 100 U/mL. These studies reported that there was no significant difference in the TDD between patients using either type of ultra-long-acting basal insulin analogs (51,52).…”

Section: Discussionsupporting

confidence: 92%

Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs

Hegab

2022

Front. Pediatr.

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BackgroundEstimation of insulin sensitivity factor (ISF) is essential for correction insulin doses calculation. This study aimed to assess real-life ISF among children and adolescents with type 1 diabetes using ultra-long-acting basal insulin analogs and to detect factors associated with ISF among those patients.MethodsThis prospective observational study was conducted at Sohag University Hospital, Egypt, and included 93 participants aged 6–18 years, diagnosed with T1DM for at least 1 year and using insulin glargine 300 Units/mL or insulin degludec 100 Units/mL as basal insulin. The ISF, insulin-to-carbohydrate ratio (ICR) and insulin doses were initially assessed then adjusted as required. The participants were regularly contacted throughout the follow-up period. Glycemic control parameters were assessed after 3 months.ResultsThe ISF showed diurnal variation with higher correction dose requirements for the morning than for the rest of the day (p < 0.001). This pattern of diurnal variation was found in participants with different pubertal stages and in participants using either type of ultra-long acting basal insulin analogs. There was no significant difference between the ISF calculated according to the 1800 rule [1800/Total daily insulin dose (TDD)] and the morning ISF (p = 0.25). The 1800 rule-calculated ISF was significantly lower than the actual ISF for the afternoon (p < 0.001) and the evening (p < 0.001). ISF at different times of the day were significantly correlated with age, body mass index, pubertal stage, diabetes duration, TDD, and ICR. Multiple regression analysis revealed that ICR was the most significant factor associated with ISF. Linear regression analysis revealed that the ISF (in mg/dL) for any time of the day could be estimated as 5.14 × ICR for the same time of the day (coefficient = 5.14, 95% confidence interval: 5.10–5.19, R2 = 0.95, p < 0.001).ConclusionDiurnal variation of ISF that had to be considered for proper calculation of correction doses. This diurnal variation was found in children and adolescents with different pubertal stages. The 1800 rule was appropriate for the morning correction doses but not in the afternoon or the evening. The TDD and the ICR could be used for ISF estimation.

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Section: Discussionsupporting

confidence: 92%

Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs

Hegab

2022

Front. Pediatr.

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“…To date, the OneCare 25 study is the only RWE study including CGM data for glycemic variability in people living with T1D who were switched from a first-generation basal insulin analog (Gla-100 or detemir) to either Gla-300 or iDeg-100. OneCare was an observational, retrospective, cross-sectional study in Spain analyzing 14 days of consecutive CGM use with data from the FreeStyle Libre device (Abbott), captured 3–24 months after the switch.…”

Section: Real-world Evidencementioning

confidence: 99%

“…Compared with OneCare, 25 COMET-T is a prospective study (vs retrospective), covers different basal insulins as the reference treatment (vs Gla-100 or iDeg-100), and different CGM devices available in clinical practice (vs FreeStyle Libre only). Furthermore, COMET-T covers an observational period of 24 weeks.…”

Section: Real-world Evidencementioning

confidence: 99%

Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Mader

Gölz²,

Bilz

et al. 2022

BMJ Open Diab Res Care

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Short-term glycemic variability is associated with the risk of hypoglycemia and hyperglycemia in people living with type 1 diabetes and can potentially affect clinical outcomes. Continuous glucose monitoring (CGM) is of increasing importance to evaluate glycemic variability in greater detail. Specific metrics for assessing glycemic variability were proposed, such as the SD of mean glucose level and associated coefficient of variation, and time in target glucose range to guide study designs, therapy and allow people with diabetes more transparency in interpreting their own CGM data. Randomized controlled trials (RCT) and real-world evidence provide complementary information about the efficacy/effectiveness and safety of interventions. Insulin glargine 300 U/mL (Gla-300) has a longer lasting and less variable action than insulin glargine U100 (Gla-100) with a lower risk of hypoglycemia. While insulin degludec U100 (iDeg-100) was associated with lower glucose values but more time below range in one randomized study compared with Gla-300, Gla-300 was associated with a higher per cent time in range, but also above the therapeutic range. However, a real-world study did not find differences during the day between Gla-300 and iDeg-100. The upcoming InRange RCT is the first head-to-head comparison of Gla-300 with iDeg-100 using CGM in an international population using CGM metrics as the primary endpoint. The non-interventional COMET-T real-world study will determine the real-world effectiveness of Gla-300 using CGM metrics and cover a broad spectrum of clinical practice decisions irrespective of the prior basal insulin.

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“…The OneCare observational, retrospective cohort, cross-sectional, multicentre study compared the effectiveness and safety of Gla-300 versus Deg-100 over a four-week period [ 36 ] in adult patients with T1DM. Gla-300 and Deg-100 showed a significantly different percentage of time in the target glucose range (3.9–10 mmol/L, 70–180 mg/dL) at night (Gla-300 52.4% vs Deg-100 46.2%, p = 0.0182).…”

Section: Pharmacokinetic and Pharmacodynamic Profiles Of Gla-300mentioning

confidence: 99%

“…No significant differences were reported for HbA1c values between cohorts [ 35 ]. Overall, in this real-world setting, the safety and effectiveness of Gla-300 and Deg-100 were similar in sub-optimally controlled T1DM patients switching from the first-generation basal insulins [ 36 ].…”

Section: Pharmacokinetic and Pharmacodynamic Profiles Of Gla-300mentioning

confidence: 99%

Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

Maffeis

Rabbone

2022

Pediatr Drugs

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The pharmacokinetic and pharmacodynamic properties of the second-generation basal insulin glargine 300 Units/mL (Gla-300) may be of benefit in the treatment of type 1 diabetes mellitus (T1DM). Gla-300 provides a stable and sustained timeaction profile, which is associated with glycaemic control and flexible dosing schedule. This review summarises the available evidence on the safety and efficacy of Gla-300 in children and adolescents with T1DM. Gla-300 is as effective as the firstgeneration basal insulin glargine 100 Units/mL (Gla-100), a standard of care for patients with diabetes in reducing HbA1c, and shows a lower risk of severe hypoglycaemia and hyperglycaemia in children and adolescents with T1DM. However, Gla-300 and Gla-100 are not bioequivalent and are not directly interchangeable. Real-world studies on patients aged 6-17 years are limited. To date, only one small study assessed the effectiveness and safety of Gla-300 versus Gla-100 in newly diagnosed T1DM paediatric patients, confirming the treatment safety and effectiveness of Gla-300 in clinical practice. Gla-300 is a longer-acting basal insulin alternative in the management of children (aged ≥ 6 years) and adolescents with T1DM.

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Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study

Cited by 14 publications

References 40 publications

Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs

Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs

Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

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