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CGM Use Reduces Hypoglycemia in Older Type 1 Diabetes Patients

type 1 diabetes

Recent research has found that the use of continuous glucose monitoring (CGM) in older adults with type 1 diabetes can reduce the incidence of hypoglycemia. These results stem from a six-month, multi-site clinical trial called the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) Study Group. This trial was published in the Journal of the American Medical Association (JAMA). 

Older patients with type 1 diabetes are susceptible to hypoglycemia, specifically in those who have had the chronic disease for a long time. Hypoglycemia occurs when one’s blood sugar becomes dangerously low. This can cause an altered mental state and potentially seizure and loss of consciousness that can result in death. This new research, however, suggests that older adults who use CGM devices can significantly decrease their risk of hypoglycemia while also lowering their hemoglobin A1c (HbA1c) levels.

Background of the CGM Study

The research team carried out this study to evaluate whether CGM use can decrease the incidence of hypoglycemia in older type 1 diabetes patients. These devices are designed to continuously measure one’s blood glucose levels, offering a convenient and minimally invasive means of monitoring diabetes. The device typically takes the form of a small wearable patch that relays blood glucose data to the user’s smartphone via Bluetooth.

“Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have difficultly recognizing symptoms of hypoglycemia or cognitive impairment,” said the study’s principal investigator Laura Young, MD, Ph.D., associate professor of medicine in the division of endocrinology and metabolism at the UNC School of Medicine.

Young and colleagues conducted a randomized, controlled trial with 203 participants aged 60 years or older at UNC-Chapel Hill and 21 other centers. Roughly half of the participants were given insulin through an insulin pump while the remainder received daily insulin injections. As for blood glucose measurements, half of the participants were given a Dexcom CGM to monitor their levels while the other half used the traditional finger-stick method.

Success of Wearable Sensors in Reducing Hypoglycemia

The team found that the time spent with glucose levels in a hypoglycemic range, defined as less than 70 mg/dl, was reduced from 73 minutes each day to only 39 minutes per day in the CGM group. This change was observed throughout the six-month study. This is much better than the control group, who went from 68 minutes to 70 minutes per day over the course of the study.

The findings of this study also suggest that CGM users are less likely to have severe hypoglycemic events than those using traditional finger-stick tests, with 10 participants of the control group having severe hypoglycemic events compared to only one in the CGM group. Half of the severe events in the control group were also accompanied by seizure or unconsciousness, symptoms that were absent in the one case among the CGM group.

Decreasing the incidence of hypoglycemia did not result in poor overall glucose control. This was shown in the average HbA1c levels of the CGM patients, a number that reflects blood sugar control over three months. HbA1c values for the CGM group decreased from 7.6% to 7.2% during the study, while the minimal decrease in the control group was only from 7.5% to 7.4%. The target HbA1c set by the American Diabetes Association is 7.0% or less, but targets for the patient population involved in this study are more lenient. Those using CGMs also remained in the target glucose range of 70-180 mg/dl for over two more hours each day as well. Among the profound findings of this trial was that 81% of the participants were still using their CGM sensors daily at the six-month mark, indicating that elderly patients with type 1 diabetes are willing to use the technology.

“For too long, the older population with diabetes has suffered from not-so-benign neglect from the medical community,” explained Young. “Despite the high prevalence of diabetes and its complications in this age group, very few studies have addressed the potential utility of new technologies in this population. In part, this may be due to the mistaken belief that older adults can’t manage or benefit from advanced technologies. Our study shows quite the opposite. Not only does CGM improve safety in older adults, it actually improves overall glycemic control. Moreover, the overwhelming majority of patients in our study used CGM most days for the entire duration of the study, demonstrating a high level of comfort with the technology in this population.”

The improvement in patient condition was seen both in those who used the insulin pump with their CGM and the multiple daily insulin injections as well, indicating that older patients who don’t want to switch to the pump can still stand to benefit from CGM technology.

Source: Medical Xpress

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CGM News

Release of Dexcom’s Newest CGM Delayed By COVID-19

diabetes

Dexcom has recently acknowledged that the COVID-19 pandemic will likely delay the launch of the G7, their latest continuous glucose monitoring (CGM) sensor.

“We remain confident in our ability to deliver G7, but acknowledge that the timing of the pivotal trial will be delayed due to the pausing of new trials at most clinical sites,” said Kevin Sayer, Dexcom CEO, in the company’s first-quarter earnings call. This statement was derived from SeekingAlpha transcripts.

Due to coronavirus-related setbacks, Sayer predicts that the G7 trial will be delayed for at least six months. This is a significant setback from the originally planned launch in 2021, with a limited launch planned for the end of this year if approved by the FDA.

Dexcom G7 Trial Delayed Due to COVID-19

Although a delay in the G7 trial was expected by most due to COVID-19, Matthew O’Brien, an analyst at Piper Jaffray, notes that six months exceeds these expectations. Part of the reason for this seemingly prolonged setback is that O’Brien thought the trial was set to only last 14-days. Sayer emphasized that this is not the case.

“If we could run a 14-day study and put several hundred people on it for 14 days that would be relatively simple,” he explained. “These trials are not that simplistic. There’s going to be at least four in-clinic days where blood is drawn for 12 hours and we can only handle two to three patients at a time, at a clinic per day. So, these trials are very well orchestrated and scheduled from a logistics perspective. We do not know when clinics who run these trials are going to open back up and allow patients to run these kinds of studies.”

Sayer noted that it will take quite some time before large clinics where these studies are conducted will even resume seeing patients and that letting these patients partake in these trials is a step past that. This, in addition to the challenge presented by receiving FDA approval, makes the marketing of the G7 something that will be difficult to achieve for some time. Sayer added that getting the G7 approved for interoperable continuous glucose monitoring (iCGM) is another hurdle they must overcome. This designation allows the device to be used interoperably with automated insulin dosing systems. Though this is difficult, Dexcom accomplished this previously with their G6 CGM.  

“We’re not shooting for just anything. We’re shooting for high iCGM standards and that is a high bar, that is not an arbitrary bar set by the FDA,” Sayer said. “That’s a high bar we’ve met with G6 and we executed a perfect study to get that done. We’ve got to execute perfection again. So, we’ve given ourselves this timeframe to make sure all our plans are locked down, that we can get the centers open, they can go and do this, and we’ll be methodical and thoughtful about it.”

Adapting to the COVID-19 Market

In addressing this setback to Dexcom’s operations, Sayer highlights the capabilities that his company already has.

“While we wait, and sometimes we forget, we have a fantastic product of what we have in G6, and we will continue to refine and make that better,” he said.

CGM sales are also down due to fewer patients being seen in doctors’ offices, limiting the number of new CGM patients that will become established. Telemedicine has helped combat this, however, with digital consultations leading to some new CGM sales.

Dexcom also withdrew its revenue guidance for 2020 due to the pandemic, previously expecting a 17% to 20% revenue increase this year.

“To be clear, this decision does not necessarily imply upside or downside to our prior guidance,” explained Quentin Blackford, Dexcom’s COO and CFO. “Our first quarter performance was above our expectations and, apart from the uncertainty created by COVID-19, we would be in a position to raise our guidance today. Ultimately, we believe the underlying demand for CGM has not changed despite the situation with COVID-19.”

Blackford noted that Dexcom is studying the macroeconomic environment to assess employment levels that will affect the company’s new COVID-19 financial assistance program. The company plans to provide financial aid to current customers who have lost their health insurance due to the pandemic. This program is set to launch in the next coming weeks, providing customers with up to two 90-day shipments of CGMs for $45 each.

Despite the company’s optimism, Blackford indicates that there is less predictability in this current situation.

“Predicting all of these future variables has been difficult, and we found it prudent to temporarily suspend our guidance until visibility improves,” he said.

Source: MD+DI

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Abstracts

Vitamin D Supplementation and Prevention of Type 2 Diabetes

BACKGROUND

Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown.

METHODS

We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5.7 to 6.4%) and no diagnostic criteria for diabetes to receive 4000 IU per day of vitamin D3 or placebo, regardless of the baseline serum 25-hydroxyvitamin D level. The primary outcome in this time-to-event analysis was new-onset diabetes, and the trial design was event-driven, with a target number of diabetes events of 508.

RESULTS

A total of 2423 participants underwent randomization (1211 to the vitamin D group and 1212 to the placebo group). By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng per milliliter (from 27.7 ng per milliliter at baseline), as compared with 28.8 ng per milliliter in the placebo group (from 28.2 ng per milliliter at baseline). After a median follow-up of 2.5 years, the primary outcome of diabetes occurred in 293 participants in the vitamin D group and 323 in the placebo group (9.39 and 10.66 events per 100 person-years, respectively). The hazard ratio for vitamin D as compared with placebo was 0.88 (95% confidence interval, 0.75 to 1.04; P=0.12). The incidence of adverse events did not differ significantly between the two groups.

CONCLUSIONS

Among persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D3supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694. opens in new tab.)

Source: NEJM

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Abstracts

Risk factors and prevention strategies for diabetic ketoacidosis in people with established type 1 diabetes

Diabetic ketoacidosis (DKA) is a serious acute complication of type 1 diabetes, which is receiving more attention given the increased DKA risk associated with SGLT inhibitors. Sociodemographic and modifiable risk factors were identified with strong evidence for an increased risk of DKA, including socioeconomic disadvantage, adolescent age (13–25 years), female sex, high HbA 1c, previous DKA, and psychiatric comorbidities (eg, eating disorders and depression). Possible prevention strategies, which include the identification of people at risk based on non-modifiable sociodemographic risk factors, are proposed. As a second risk mitigation strategy, structured diabetes self-management education that addresses modifiable risk factors can be used. Evidence has found that structured education leads to reduced DKA rates. Knowledge of these risk factors and potent risk mitigation strategies are important to identify subgroups of people with an elevated DKA risk. This knowledge should also be used when adjunct therapy options with an increased DKA risk are considered. Prevention of DKA in people with type 1 diabetes is an important clinical task, which should also be addressed when SGLT inhibitors are part of therapy.

Source: The Lancet Diabetes & Endocrinology

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Abstracts

Association Between Rotavirus Vaccination and Type 1 Diabetes in Children

Importance  Because rotavirus infection is a hypothesized risk factor for type 1 diabetes, live attenuated rotavirus vaccination could increase or decrease the risk of type 1 diabetes in children.

Objective  To examine whether there is an association between rotavirus vaccination and incidence of type 1 diabetes in children aged 8 months to 11 years.

Design, Setting, and Participants  A retrospective cohort study of 386 937 children born between January 1, 2006, and December 31, 2014, was conducted in 7 US health care organizations of the Vaccine Safety Datalink. Eligible children were followed up until a diagnosis of type 1 diabetes, disenrollment, or December 31, 2017.

Exposures  Rotavirus vaccination for children aged 2 to 8 months. Three exposure groups were created. The first group included children who received all recommended doses of rotavirus vaccine by 8 months of age (fully exposed to rotavirus vaccination). The second group had received some, but not all, recommended rotavirus vaccines (partially exposed to rotavirus vaccination). The third group did not receive any doses of rotavirus vaccines (unexposed to rotavirus vaccination).

Main Outcomes and Measures  Incidence of type 1 diabetes among children aged 8 months to 11 years. Type 1 diabetes was identified by International Classification of Diseases codes: 250.x1, 250.x3, or E10.xx in the outpatient setting. Cox proportional hazards regression models were used to analyze time to type 1 diabetes incidence from 8 months to 11 years. Hazard ratios and 95% CIs were calculated. Models were adjusted for sex, race/ethnicity, birth year, mother’s age, birth weight, gestational age, number of well-child visits, and Vaccine Safety Datalink site.

Results  In a cohort of 386 937 children (51.1% boys and 41.9% non-Hispanic white), 360 169 (93.1%) were fully exposed to rotavirus vaccination, 15 765 (4.1%) were partially exposed to rotavirus vaccination, and 11 003 (2.8%) were unexposed to rotavirus vaccination. Children were followed up a median of 5.4 years (interquartile range, 3.8-7.8 years). The total person-time follow-up in the cohort was 2 253 879 years. There were 464 cases of type 1 diabetes in the cohort, with an incidence rate of 20.6 cases per 100 000 person-years. Compared with children unexposed to rotavirus vaccination, the adjusted hazard ratio was 1.03 (95% CI, 0.62-1.72) for children fully exposed to rotavirus vaccination and 1.50 (95% CI, 0.81-2.77) for children partially exposed to rotavirus vaccination.

Conclusions and Relevance  The findings of this study suggest that rotavirus vaccination does not appear to be associated with type 1 diabetes in children.

Source: JAMA Pediatrics

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