Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes

Figures & data

Table 1. HEDIS criteria for individualized HbA1c targets.

Two measures for good performance	Proportion of patients with HbA1c control (<8.0%) among all patients Proportion of patients with HbA1c control (<7.0%) among selected patients
One measure for poor performance	Proportion of patients with HbA1c poor control (>9.0%) among all patients These measures imply the need to control HbA1c <7.0% among selected populations and HbA1c <8.0% among the rest of the population
Selected populations with target HbA1c <7.0%	Patients aged <65 years in the measurement year AND without evidence of any of these diseases/conditions: Coronary artery bypass surgery or percutaneous coronary intervention Ischemic vascular disease Thoracic aortic aneurysm Chronic heart failure Prior myocardial infarction Chronic renal failure/end-stage renal disease Dementia Blindness Lower extremity amputation

HEDIS: Health Effectiveness Data and Information Set; HbA1c:  glycated hemoglobin.

Figure 1. Design of the randomized, open-label, parallel group, real-world, pragmatic Achieve Control study.

¹Available Patient Support Program for GLA-300.²Available Patient Support Program for GLA-100 and insulin detemir.ADA: American Diabetes Association; BG: blood glucose; DPP-4: dipeptidyl peptidase-4; FPG: fasting plasma glucose; GLP-1 RA: glucagon-like peptide-1 receptor agonist; HbA1c: glycated hemoglobin; OAD: oral antidiabetes drug; PRO: patient-reported outcome; PSP: patient-support program; Q: quarter; QD: once daily; SGLT-2: sodium-dependent glucose cotransporter-2; SU: sulfonylureas; TZD: thiazolidinedione; T2D: type 2 diabetes.

Figure 2. Major outcomes measures and timing of their ascertainment.

*Defined as a symptomatic event with documented BG ≤70 mg/dL at any time of day.**Defined as a symptomatic event with documented BG <54 mg/dL at any time of day.HbA1c: glycated hemoglobin; BG: blood glucose; FPG: fasting plasma glucose; HEDIS: Health Effectiveness Data and Information Set.

Table 2. Patient-reported outcomes instruments.

Instrument	Version/domains	Assessment	Assessment scale	Timing
GES measure	Adapted for use in diabetes	Impact of treatment	5-point scale (excellent, good, moderate, poor, or worsening)	6 months 12 months
DTSQs [36]	Total treatment satisfaction Hyperglycemia perception Hypoglycemia perception	Patient satisfaction with treatment Patient perception of BG control	Likert scale from 0 to 6 (higher scores indicate greater satisfaction)	At 6 months and at 12 months
DTSQc [36]	Total treatment satisfaction Hyperglycemia perception Hypoglycemia perception	Change in patient satisfaction with treatment	−3 to +3 for each domain (sum of scores ranges from −18 to +18)	Baseline to 12 months
Hypoglycemia Patient Questionnaire [37]	Questions 5 and 6 to be used for assessment of the end point	Frequency of moderate and severe (per ADA definitions) hypoglycemia during the study	Proportion of patients reporting hypoglycemia between treatment groups	At 6 months and at 12 months

GES: Global Evaluation of Treatment Effectiveness Scale; DTSQc: Diabetes Treatment Satisfaction Questionnaire Change version; DTSQs: Diabetes Treatment Satisfaction Questionnaire Status version; ADA: American Diabetes Association; BG: blood glucose.

Table 3. ADA definitions of hypoglycemia in diabetes [37].

Hypoglycemia definition	Description
Severe	Requiring assistance of another person
Documented symptomatic	Typical symptoms accompanied by a measured BG ≤70 mg/dL
Asymptomatic	No typical symptoms, but with measured BG ≤70 mg/dL
Probably symptomatic	Typical symptoms, but not accompanied by a BG determination
Pseudo-hypoglycemia	Any of the typical symptoms accompanied by a measured BG concentration >70 mg/dL, but approaching that level

ADA: American Diabetes Association; BG: blood glucose.

Bradley C. Diabetes treatment satisfaction questionnaire (DTSQ). In: Bradley C, editor. Handbook of psychology and diabetes. Chur: Harwood Academic Publishers; 1994. p. 111–132.

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Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36:1384–1395.

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