Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures

Brod, Meryl; Christensen, Torsten; Hammer, Mette; Busk, A. K.; Bushnell, Donald M.

doi:10.1007/s11136-011-9886-7

Cited by 24 publications

(33 citation statements)

References 8 publications

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“…DUAL IX was a phase IIIb, open‐label, two‐arm parallel, treat‐to‐target, randomized trial, in insulin‐naïve people with inadequately controlled T2D on a stable dose of an SGLT2 inhibitor, conducted at 74 sites in 11 countries between May 2016 and October 2017. It was conducted in accordance with International Conference on Harmonisation Good Clinical Practice and the Declaration of Helsinki . The 32‐week trial comprised a 2‐week screening period, a 26‐week treatment period, and two follow‐up safety assessments at 7 (+3) days and 30 days (+3 days) after last dose of randomized treatment.…”

Section: Methodsmentioning

confidence: 99%

Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes

Philis‐Tsimikas

Billings

Busch

et al. 2019

Diabetes Obesity Metabolism

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Aim To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add‐on to sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor therapy. Materials and methods In this 26‐week, phase IIIb, open‐label, parallel‐group, treat‐to‐target trial, conducted at 74 sites in 11 countries, insulin‐naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53–97 mmol/mol (7.0–11.0%), body mass index 20–40 kg/m2 and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once‐daily IDegLira or IGlar U100, both as add‐on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26. Results A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%‐points) with IDegLira and 18 mmol/mol (1.7%‐points) with IGlar U100; confirming non‐inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change –3.90 mmol/mol; 95% confidence interval [CI] –5.45; –2.35 (−0.36%‐points; 95% CI –0.50, –0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference −1.92 kg; 95% CI –2.64, –1.19); severe or blood‐glucose‐confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference −15.37 U; 95% CI –19.60, −11.13). The overall treatment‐emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates. Conclusions The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population.

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Section: Methodsmentioning

confidence: 99%

Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes

Philis‐Tsimikas

Billings

Busch

et al. 2019

Diabetes Obesity Metabolism

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“…PROs were collected at three scheduled visits (baseline, week 12 and week 26) and domain summary scores and change from baseline in summary scores were calculated. PRO questionnaires included the Treatment‐Related Impact Measure for Diabetes (TRIM‐D), comprising 28 items in five domains and a total score, and the Short Form‐36 Health Survey version 2 (SF‐36 v2), consisting of 36 items in eight domains with two component summary scores . TRIM‐D scales (domain and total score) range from 0 to 100, with a higher score corresponding to a better outcome .…”

Section: Methodsmentioning

confidence: 99%

IDegLira improves patient‐reported outcomes while using a simple regimen with fewer injections and dose adjustments compared with basal–bolus therapy

Miller¹,

Doshi²,

Grøn

et al. 2019

Diabetes Obesity Metabolism

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Aims Basal–bolus therapy is associated with greater treatment burden and lower adherence compared with more simplified regimens. This post hoc analysis studied the difference between insulin degludec/liraglutide (IDegLira) and basal–bolus therapy on number of injections, dose adjustments and patient outcomes in the DUAL VII trial. Materials and methods DUAL VII was a 26‐week, open‐label trial in which patients with uncontrolled type 2 diabetes who were using metformin and insulin glargine 100 units/mL (20–50 U) were randomized 1:1 to IDegLira (N = 252) or basal–bolus (insulin glargine U100 + insulin aspart ≤4 times/day) (N = 254). This post hoc analysis reports the observed mean number of injections and cumulative dose adjustments during 26 weeks of treatment. Patient‐reported outcomes (Treatment‐Related Impact Measure – Diabetes [TRIM‐D] and Short Form‐36 Health Survey version 2 [SF‐36v2]) were collected at scheduled visits and change from baseline scores calculated. Results The clinical benefits (non‐inferior HbA1c reductions, weight benefit, less hypoglycaemia) of IDegLira vs basal–bolus therapy were achieved with fewer cumulative dose adjustments (16.6 vs 217.2, respectively) and fewer injections (1 vs ≥3 per day, respectively). Patients treated with IDegLira experienced significant improvements across all TRIM‐D domains compared with those undergoing basal–bolus therapy. The SF‐36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228). Conclusions These findings, combined with the DUAL VII results, suggest that IDegLira, through a more simplified regimen versus basal–bolus therapy, may help improve patient adherence and improve patient outcomes related to diabetes management, treatment burden and mental health, which in turn may assist in the timely achievement of glycaemic control in clinical practice.

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“…A TRIM-DD questionnaire was utilized to assess pen injector function and bother and was completed at the end of each 16week treatment period. This questionnaire has been previously validated for use in clinical trials 21 and linguistic validation was provided by researchers in the Mapi Institute. To assess patient preference, a 7 item questionnaire developed internally by Novo Nordisk was also provided to the subjects at the end of the trial/following completion of both 16 week treatment periods (Supplementary Material).…”

Section: Study Design Procedures and Materialsmentioning

confidence: 99%

“…The previously published results within the TRIM-DD domains of pen-injector function and device bother are supplemented here (Figure 1) with the eight individual TRIM-DD items, consisting of five questions assessing function and three questions assessing bother 21,22 . In general, patients rated both pen injectors highly, but significantly more patients gave responses in the most positive indicators for questions related to device function (extremely easy and extremely confident, for all questions) for FlexTouch ( Figure 1(a,b)).…”

Section: Treatment-related Impact Measure -Diabetes Device Questionnairementioning

confidence: 99%

Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes

Warren

Brod

Håkan‐Bloch

et al. 2019

Current Medical Research and Opinion

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Objective: Type 2 diabetes (T2D) is associated with insulin resistance and deteriorated glycemic control that can be restored with insulin injections. Choice of insulin pen injector may affect complexity, adherence, efficacy of treatment and health-related quality of life. We describe detailed patientreported outcomes (PROs) on treatment impact and preference comparing insulin degludec (degludec) using FlexTouch 1 versus insulin glargine U100 (glargine U100) with SoloStar 2 pen injector. Methods: In this randomized, multicenter (USA), open-label, crossover, treat-to-target study (NCT01570751), patients with T2D using high-dose insulin (!81 U/day from vials) were randomized (n ¼ 145) 1:1 to 16 weeks of degludec U200 (3 mL FlexTouch) followed by 16 weeks of glargine U100 (3 mL SoloStar) or vice versa. PRO questionnaires assessed treatment impact and patient preference of pen injectors. Results: Significantly more patients (p < .01) considered FlexTouch "extremely easy" for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%) and adjusting the dose (63.2 vs. 44.4%), and significantly more were "very" or "extremely confident" in using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloStar. Significantly more were "not at all bothered" by device discomfort (74.3 vs. 54.1%), whereas device size (83.8 vs. 80.0%) or public use (69.9 vs. 60.7%) were numerically in favor of FlexTouch. Significantly more patients preferred degludec treatment with FlexTouch (59 vs. 22%), preferred to continue (67 vs. 15%) and recommend (67 vs. 14%) use of FlexTouch compared with SoloStar with glargine U100. Conclusions: In this randomized, crossover trial, lower treatment impact and higher patient preference were reported for FlexTouch versus SoloStar pen injectors. ARTICLE HISTORY

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Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures

Cited by 24 publications

References 8 publications

Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes

Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes

IDegLira improves patient‐reported outcomes while using a simple regimen with fewer injections and dose adjustments compared with basal–bolus therapy

Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes

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