Table 1Summary of process measures, intermediate outcomes, and clinical outcomes relevant to studies of intensive insulin therapy and continuous glucose monitoring

Process MeasuresIntermediate OutcomesClinical Outcomes
Ratio of basal to bolus insulin

Frequency of adjusting insulin therapy

Adherence to insulin therapy/sensor use

Frequency of professional or allied health visits
Primary
Hemoglobin A1c

Secondary
Hyperglycemia
Weight gain
Hypoglycemia frequency
Microvascular*
Nephropathy
Retinopathy
Neuropathy

Macrovascular*
Coronary heart disease
Cerebrovascular disease
Peripheral arterial disease

Severe hypoglycemia

Quality of life

Mortality

Fetal outcomes

Maternal pregnancy outcomes
C-section rates
*

We only included objective assessments of microvascular and macrovascular outcomes (i.e., we will be excluded patient self-reported microvascular and macrovascular outcomes).

Fetal outcomes include gestational age, birth weight, frequency of neonatal hypoglycemia, birth trauma, major and minor anomalies, admission to a neonatal intensive care unit, stillbirth, neonatal and perinatal mortality.

From: Introduction

Cover of Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness
Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness [Internet].
Comparative Effectiveness Reviews, No. 57.
Golden SH, Brown T, Yeh HC, et al.

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