Dataset Information

Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.

ABSTRACT:

Objective

This study evaluated the association of time in range (TIR) of 70-180 mg/dL (3.9-10 mmol/L) with the development or progression of retinopathy and development of microalbuminuria using the Diabetes Control and Complications Trial (DCCT) data set in order to validate the use of TIR as an outcome measure for clinical trials.

Research design and methods

In the DCCT, blood glucose concentrations were measured at a central laboratory from seven fingerstick samples (seven-point testing: pre- and 90-min postmeals and at bedtime) collected during 1 day every 3 months. Retinopathy progression was assessed every 6 months and urinary microalbuminuria development every 12 months. Proportional hazards models were used to assess the association of TIR and other glycemic metrics, computed from the seven-point fingerstick data, with the rate of development of microvascular complications.

Results

Mean TIR of seven-point profiles for the 1,440 participants was 41 ± 16%. The hazard rate of development of retinopathy progression was increased by 64% (95% CI 51-78), and development of the microalbuminuria outcome was increased by 40% (95% CI 25-56), for each 10 percentage points lower TIR (P < 0.001 for each). Results were similar for mean glucose and hyperglycemia metrics.

Conclusions

Based on these results, a compelling case can be made that TIR is strongly associated with the risk of microvascular complications and should be an acceptable end point for clinical trials. Although hemoglobin A_1c remains a valuable outcome metric in clinical trials, TIR and other glycemic metrics-especially when measured with continuous glucose monitoring-add value as outcome measures in many studies.

SUBMITTER: Beck RW

PROVIDER: S-EPMC6905478 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.

Beck Roy W RW Bergenstal Richard M RM Riddlesworth Tonya D TD Kollman Craig C Li Zhaomian Z Brown Adam S AS Close Kelly L KL

Diabetes care 20181023 3

<h4>Objective</h4>This study evaluated the association of time in range (TIR) of 70-180 mg/dL (3.9-10 mmol/L) with the development or progression of retinopathy and development of microalbuminuria using the Diabetes Control and Complications Trial (DCCT) data set in order to validate the use of TIR as an outcome measure for clinical trials.<h4>Research design and methods</h4>In the DCCT, blood glucose concentrations were measured at a central laboratory from seven fingerstick samples (seven-poin ...[more]

PMID: 30352896

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Project description:BackgroundSurgical audit, sometimes including public reporting, is an important foundation of high quality health care. We aimed to assess the validity of a novel outcome metric, days at home up to 30 days after surgery, as a surgical outcome measure in clinical trials and quality assurance.MethodsThis was a multicentre, registry-based cohort study. We used prospectively collected hospital and national healthcare registry data obtained from patients aged 18 years or older undergoing a broad range of surgeries in Sweden over a 10-year period. The association between days at home up to 30 days after surgery and patient (older age, poorer physical status, comorbidity) and surgical (elective or non-elective, complexity, duration) risk factors, process of care outcomes (re-admissions, discharge destination), clinical outcomes (major complications, 30-day mortality) and death up to 1 year after surgery were measured.FindingsFrom January, 2005, to December, 2014, we obtained demographic and perioperative data on 636,885 patients from 21 Swedish hospitals. Mortality at 30 days and one year was 1.8% and 7.3%, respectively. The median (IQR) days at home up to 30 days after surgery was 27 (23-29), being significantly lower among high-risk patients, those recovering from more complex surgical procedures, and suffering serious postoperative complications (all p < 0.0001). Patients with 8 days or less at home up to 30 days after surgery had a nearly 7-fold higher risk of death up to 1 year postoperatively when compared with those with 29 or 30 days at home (adjusted HR 6.78 [95% CI: 6.44-7.13]).InterpretationDays at home up to 30 days after surgery is a valid, easy to measure patient-centred outcome metric. It is highly sensitive to changes in surgical risk and impact of complications, and has prognostic importance; it is therefore a valuable endpoint for perioperative clinical trials and quality assurance.FundingSwedish National Research Council Medicine and Stockholm County Council ALF-project grant (LE), and the Australian National Health and Medical Research Council (PM).

Dataset Information

Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.

Objective

Research design and methods

Results

Conclusions

Publications

Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.

Similar Datasets

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