Patient-Led Versus Physician-Led Titration of Insulin Glargine in Patients with Uncontrolled Type 2 Diabetes: A Randomized Multinational Atlas Study

Garg, Satish K.; Admane, K; Freemantle, Nick; Odawara, Masato; Pan, Changyu; Misra, Anoop; Jarek-Martynowa, Iwona R.; Abbas-Raza, Syed; Mirasol, Roberto; Perfetti, Riccardo

doi:10.4158/ep14079.or

Cited by 41 publications

(82 citation statements)

References 19 publications

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“…ATLAS and AT.LANTUS were both 24‐week, multicentre, randomized, open‐label studies that demonstrated significant improvements in glycaemic control with self‐managed over physician‐managed titration of Gla‐100, in uncontrolled T2DM . There was no significant difference in the proportion of participants with self‐ versus physician‐managed titration achieving HbA1c <7.0% (<53 mmol/mol) without severe hypoglycaemia in ATLAS, or with severe hypoglycaemia in AT.LANTUS . By contrast, target achievement without hypoglycaemia was improved with self‐ versus physician‐managed titration in the present Take Control study, although it should be noted that SMPG was used as the glycaemic target, rather than HbA1c, as in ATLAS and AT.LANTUS.…”

Section: Discussionmentioning

confidence: 99%

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Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes

Russell‐Jones

Dauchy

Delgado

et al. 2019

Diabetes Obesity Metabolism

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Aim To compare the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL (Gla‐300) in people with inadequately controlled type 2 diabetes. Methods Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multi‐national, open‐label, controlled, two‐arm, parallel‐group study in insulin‐naïve and pre‐treated participants, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non‐inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant‐reported outcomes (PROs). Results At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non‐inferiority (P < 0.0001) and superiority (P = 0.0247) of self‐ versus physician‐managed titration. Significantly more of the self‐ than physician‐managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self‐management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self‐managed group. Conclusions Self‐managed titration of Gla‐300 was superior to physician‐managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency.

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Section: Discussionmentioning

confidence: 99%

“…In AT.LANTUS and ATLAS, there was a higher risk of symptomatic hypoglycaemia with self ‐ vs physician‐managed titration . Such results may cause physicians to be reluctant to encourage their patients to self‐titrate, in order to avoid hypoglycaemia.…”

Section: Discussionmentioning

confidence: 99%

Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes

Russell‐Jones

Dauchy

Delgado

et al. 2019

Diabetes Obesity Metabolism

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“…Like in the other studies, patient-led insulin glargine titration achieved better results with respect of glycemic control for the price of a slight increase in nonsevere nocturnal hypoglycemic events. 9 A different approach to achieve effective up-titration of basal insulin doses with less resource requirements is the use of modern communication technologies, such as text messaging via mobile phones. In a recent pilot study, 61 patients were randomized to either perform regular physician visits to obtain their dose recommendations or to use text messages for the same purpose.…”

Section: Discussionmentioning

confidence: 99%

Real-World Data Collection Regarding Titration Algorithms for Insulin Glargine in Patients With Type 2 Diabetes Mellitus

Pfützner¹,

Stratmann

Funke³

et al. 2016

J Diabetes Sci Technol

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The primary objective of this study was to collect data regarding the effectiveness of different dose titration algorithms (TAs) for optimization or initiation of basal insulin supported oral therapy (BOT) in patients with type 2 diabetes. A total of 50 patients were enrolled in this trial (17 women, 33 men, age 63 ± 8 years, HbA1c 7.9 ± 0.8%). The investigator decided on an individual basis to apply any of 4 standard TAs: standard (S: fasting glucose target 90-130 mg/dL, n = 39), standard-fast titration (S-FT: 90-130 mg/dL, larger dose increments at FBG < 180 mg/dl, n = 1), less tight (LT: 110-150 mg/dL, n = 5), and tight (T: 70-100 mg/dL, n = 5). During the next 30 days daily contacts were used to adapt the insulin dose. The majority of all patients (70%) achieved a stable insulin glargine dose within 5 ± 6 days after initiation of the dose titration. HbA1c improved from 7.9 ± 0.8% to 7.5 ± 0.7% (P < .001). In total, 1300 dose decisions were made (1192 according to the TA and 108 by the physicians independently from the TA in 29 patients [58% of study population]). Reasons for TA-overruling dosing decisions were hypoglycemic events (14 mild/4 moderate) in 9 patients. In the majority of these cases (89.8%), the physician recommended continuation of the previous dose or a higher dose. The majority of FBG values were within the respective target range after 4 weeks. In conclusion, the insulin glargine TAs delivered safe dose recommendations with a low risk of hypoglycemia, which successfully led to a stable dose in the vast majority of patients.

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“…In addition, we did not evaluate the ability of self-titration of insulin dosage in each patient. Because patient-lead insulin titration allows for more frequent insulin dose titration, which can lead to better glycemic control and lifestyle flexibility than physician-lead insulin titration [40], insulin titration method might be associated with adherence to insulin injection and HRQOL. Secondly, adherence to medication schedules may be affected by the Japanese universal health insurance system because large part of medication cost are covered and the patient does not need to pay the total expense.…”

Section: Discussionmentioning

confidence: 99%

Diabetes treatment-related quality of life is associated with levels of self-care activities in insulin injection among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 8)

et al. 2015

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Patient-Led Versus Physician-Led Titration of Insulin Glargine in Patients with Uncontrolled Type 2 Diabetes: A Randomized Multinational Atlas Study

Cited by 41 publications

References 19 publications

Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes

Take Control: A randomized trial evaluating the efficacy and safety of self‐ versus physician‐managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes

Real-World Data Collection Regarding Titration Algorithms for Insulin Glargine in Patients With Type 2 Diabetes Mellitus

Diabetes treatment-related quality of life is associated with levels of self-care activities in insulin injection among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 8)

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