Health Medical
DDHA 8003 Walden University Mitochondrial Stability in Diabetic Retinopathy Discussion

DDHA 8003

Walden University


Question Description

I’m studying for my Health & Medical class and don’t understand how to answer this. Can you help me study?

Assignment: Online Resources in the Health Field

Topic: You can chose a topic for finding clinical trials...peer-reviewed article PLEASE

Online learning and research presents many challenges, just the same as traditional learning. These challenges include finding reliable, current, and legitimate scholarly resources. You may already have favorite online resources and databases that you use or have found useful in the past. As you begin your program of study, you will identify many resources you may rely on for current peer-reviewed information.

For this Assignment, review your Learning Resources, then research and locate one peer-reviewed article in the Walden Library. These may include resources identified in this course through the Walden Library, as well as those not mentioned in this course.

The topic of your article should be an issue that is important to you and related to your health field. It should be different from the topic you chose for your initial posting to the Week 2 Discussion.

The Assignment (2 pages)

  • Explain the process of finding your article and how you determined it was peer-reviewed.
  • Summarize the article and its findings.
  • Explain how this article expands your knowledge of an important issue related to your field of study.
  • Expand on your insights utilizing the Learning Resources.

Student has agreed that all tutoring, explanations, and answers provided by the tutor will be used to help in the learning process and in accordance with Studypool's honor code & terms of service.

Final Answer




Diabetes Care Volume 42, March 2019

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

Roy W. Beck,1 Richard M. Bergenstal,2
Tonya D. Riddlesworth,1 Craig Kollman,1
Zhaomian Li,1 Adam S. Brown,3 and
Kelly L. Close4

Diabetes Care 2019;42:400–405 |


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

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.

Mean TIR of seven-point profiles for the 1,440 participants was 41 6 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.

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 A1c remains a valuable outcome metric in
clinical trials, TIR and other glycemic metricsdespecially when measured with
continuous glucose monitoringdadd value as outcome measures in many studies.


Jaeb Center for Health Research, Tampa, FL
International Diabetes Center Park Nicollet,
Minneapolis, MN
Close Concerns, San Francisco, CA
The diaTribe Foundation, San Francisco, CA

Corresponding author: Roy W. Beck, rbeck@jaeb
Received 6 July 2018 and accepted 12 September

Hemoglobin A1c (A1C) became the gold standard for assessing glycemic management
after the landmark Diabetes Control and Complications Trial (DCCT) demonstrated the
strong association between A1C levels and the risk of chronic diabetic vascular
complications, and laboratory methods were developed so that A1C levels could be
readily measured with a high degree of precision. Although its important role in
diabetes management as a clinical trials outcome and as a predictor of long-term
diabetic complications cannot be overstated, A1C does have certain limitations.
A1C is a measure of hyperglycemia, but it provides no indication of hypoglycemia, glycemic variability, or daily patterns of glycemia. Notably, considerable

This article contains Supplementary Data online
© 2018 by the American Diabetes Association.
Readers may use this article as long as the work
is properly cited, the use is educational and not
for profit, and the work is not altered. More information is available at http://www.diabetesjournals

See accompanying article, p. 345.

interindividual variability exists in the
relationship between A1C and mean
glucose concentration so that for an
individual patient, A1C may or may
not be a good indicator of glycemia (1).
This is not necessarily important when
comparing groups in a clinical trial or
computing population averages, but it
can be important in the management of
an individual patient. There are certain
well-known causes of A1C–mean glucose
discordance, such as hemoglobinopathy,
hemolytic anemia, and chronic renal
failure (2); but even when no known
condition affecting red blood cells is
present, there is a wide range of possible mean glucose concentrations for a
given A1C level (1). This is likely due, in
great part, to interindividual variation in
red blood cell life span (3). The frequent
discordance between mean glucose
and A1C has been known since at least
1990 (4), but awareness has increased
in recent years as continuous glucose
monitoring (CGM) has become more
prevalent (5).
In the last year, several organizations
published consensus statements on the
role of CGM and specific metrics to use
for assessing overall glycemic management, hyperglycemia, hypoglycemia, and
glycemic variability (6,7), and a conference was held with representatives of all
organizations to reach an agreement on
the consensus statements (8). Over time
and in these consensus statements, time
in range (TIR) of 70–180 mg/dL (3.9–
10 mmol/L) has been popularized as an
important metric to be derived from
CGM data to classify glycemic management. A survey showed that patients
also recognized TIR as an important outcome (8,9).
Despite the rapidly increasing use of
CGM, particularly in type 1 diabetes (5),
and the recognition by clinicians of its
value, the U.S. Food and Drug Administration has not accepted CGM metrics as
outcomes for making efficacy claims in
clinical trials conducted for the approval
of a new drug or device (8). The Food and
Drug Administration has indicated the
need to demonstrate the clinical relevance of CGM outcomes, similar to the
DCCT’s demonstration of the association
of A1C levels with vascular complications
(10). For a hypoglycemia outcome such
as time below 54 mg/dL, evidence already exists to provide clinical validation
of its importance in that hypoglycemia is

Beck and Associates

associated with a number of occurrences
that are clinically relevant. They include
an increased risk of subsequent severe
clinical hypoglycemia events; defective
glucose counterregulation/impaired hypoglycemia awareness, which has been
associated with an increased risk of
severe clinical hypoglycemic events;
cognitive function impairment; an increase in cardiac arrhythmias (mortality);
an increase in car accidents; an adverse
effect on quality of life, including sleep;
and reduced work productivity (11–16).
However, for commonly reported
CGM metrics, such as TIR and time in
hyperglycemia, the case of clinical relevance cannot be as easily made. The
metric TIR typically refers to the percentage of time that glucose concentrations
are between 70 and 180 mg/dL (3.9 and
10 mmol/L) and as such is primarily
determined by the amount of hyperglycemia. It is correlated with A1C, easily
understood by individuals with diabetes,
and readily computed from CGM profiles. Regulators have not accepted the
argument that because TIR is largely a
measure of hyperglycemia and is correlated with A1C, it therefore must be
associated with risk for vascular complications. Therefore, merely showing an
association with A1C has been considered
insufficient evidence to have TIR accepted
as a clinically meaningful outcome.
To conduct a prospective, longitudinal
study to assess the association of TIR with
the development of complications would
take many years and be costly. Fortunately, the DCCT collected data that are
valuable ...

ephykam (9434)
UT Austin

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