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 Both studies were published today in JAMA.
The DIAMOND study enrolled 158 patients on multiple daily insulin
injections and a baseline hemoglobin A1c (HbA1c) of 7.5% to 9.9%.
One hundred and five patients were randomly assigned to the Dexcom
G4 Platinum CGM System from Dexcom Inc, which funded the study, and
53 to self-monitored blood glucose (SMBG).
After 24 weeks, HbA1c levels were reduced from baseline by 1.1% at
12 weeks and by 1.0% at 24 weeks in the CGM group, versus reductions
of 0.5% and 0.4% in the SMBG, with a significant difference at 24
weeks of −0.6% (95% confidence interval, −0.8% to −0.3%; p<0.001).
At 24 weeks, 18% CGM patients had HbA1c levels below 7.0% versus 4%
of SMBG patients (P=0.01).
In addition, CGM was associated with greater time in the glucose
range of 70 through 180 mg/dL and less time with glucose levels
above 180 mg/dL or lower than 70 mg/dL. CGM was also associated with
less glycemic variability.
Severe hypoglycemia occurred in two patients in each group and
diabetic ketoacidosis did not occur in any patient. Patients who
received CGM reported high satisfaction with this method of
monitoring.
“This is the first randomized trial to assess the value of CGM in
patients with type 1 diabetes who receive insulin by injection,”
first author Dr. Roy Beck of the Jaeb Center for Health Research in
Tampa, Florida, told Reuters Health by email.
“In prior studies that I and others have done showing the benefits
of CGM for patients with type 1 diabetes, almost all of the
participants used an insulin pump to deliver insulin. So this study
is important for the literature in showing that CGM benefits of
similar magnitude occur in injection users. The results also are
important for the literature in showing that there was daily or
near-daily use of CGM after 6 months by almost all of the study
participants and that satisfaction with using CGM was very high,”
Dr. Beck said.
He added, “We have been seeing increases in CGM use over the last
couple of years in patients with type 1 diabetes using pumps. The
data from this study showing not only glycemic benefits but also a
high degree of satisfaction with CGM by injection users should have
the effect of increasing patient interest in using CGM as well as
endocrinologist enthusiasm for prescribing it. Most insurance
companies now cover CGM and CMS (Centers for Medicare and Medicaid
Services) very recently approved coverage through Medicare. So, I
expect we will see substantial increases in CGM use over the next
year.”
The GOLD study compared CGM (also using the Dexcom G4 system) to
SMBG in a crossover randomized study involving 161 patients who were
using multiple daily insulin injections and had baseline HbA1c
levels of at least 7.5%.
Each study intervention period lasted 26 weeks with a 17-week
washout period between CGM and SMBG. Compared with a baseline HbA1c
level of 8.6%, HbA1c levels at the end of the intervention period
were 7.9% with CGM and 8.4% with SMBG, with a difference of −0.4%
(95% CI, −0.6% to −0.3%; p<0.001).
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There was one severe hypoglycemia event in the CGM group and five in
the SMBG group. Glucose variability was significantly lower in the
CGM group. Patients reported greater satisfaction with CGM.
Commenting on the study, lead investigator Dr. Marcus Lind of the
University of Gothenburg, Sweden, noted that the DexCom G4 sensor
has shown “high accuracy and positive treatment experience” in short
evaluations, but has not been evaluated thoroughly in randomized
trials until now.
This study, he said, “shows that this sensor gives better glycemic
control in adults with type 1 diabetes treated with multiple daily
insulin injections than using regular capillary glucose testing.
Such data are needed for decision-makers to decide whether to
recommend the use of CGM in persons treated with injections.
Further, the study showed an effect on well-being, which has not
earlier been shown in randomized trials regarding CGM. Patients felt
more confident regarding risks of hypoglycemia. Further, the
glycemic variability was reduced. Of note, in spite of improving
several factors, there were no indications of harmful effects.”
In a linked editorial, Dr. Mayer Davidson of Charles R. Drew
University of Medicine and Science in Los Angeles writes,
“Additional clinical trials are needed to determine the long-term
effect of CGM and whether this approach translates to improved
health outcomes and to determine the potential utility of real-time
CGM for patients with type 1 diabetes encountered in usual clinical
practice and in patients with type 2 diabetes who require insulin
injections.”
Funding for the DIAMOND study was provided by Dexcom Inc. Several
authors reported financial relationships with the company. The GOLD
study was investigator-initiated and sponsored by the NU Hospital
Group, Trollhättan and Uddevalla, Sweden. Several authors disclosed
relationships with various companies including Dexcom Inc.
SOURCE: http://bit.ly/2jmuahY, http://bit.ly/2jmz2Dw and http://bit.ly/2jmI8jZ
JAMA 2017.
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