wWe are here to share even more highlights.
In an “extension” of the Control-IQ trial in adults (presented at ADA 2019), researchers compared the time in rangeand A1C of people using Control-IQ and those using Basal-IQ. Control-IQ is Tandem’s new automated insulin delivery system, and Basal-IQ is Tandem’s earlier system that automatically stops delivering insulin when low blood sugars are predicted. Of 109 participants in the original Control-IQ trial, 55 switched to Basal-IQ and 54 remained on Control-IQ for 13 more weeks.
- Time in range decreased from 70% to 60% at the end of 13 weeks on Basal-IQ. In the Control-IQ group, time in range fell slightly, from 71% to 68%.
- The difference in time in range was driven by a change in time spent in hyperglycemia (above 180 mg/dl). At the start of the trial extension, both groups spent 28% time in hyperglycemia. This increased to 38% in the Basal-IQ group and 31% in the Control-IQ group.
- There was no difference in time spent in hypoglycemia (below 70 mg/dl) between the two groups (1.5% in Basal-IQ vs. 1.4% in Control-IQ – just 22 minutes a day).
- A1C was 0.3% lower (0.3 percentage points) in the Control-IQ group. Both groups had an average A1C of 7.1% at baseline, rising to 7.5% in the Basal-IQ group, compared to 7.2% in the Control-IQ group.
- There were no events of severe hypoglycemia or diabetic ketoacidosis (DKA) in either group during the extension phase of the trial.
The photo below shows the change in time in range during the day (left side) and overnight (right side). The blue bar represents the group that was using Basal-IQ (PLGS). The red bar represents the group that was using Control-IQ (CLC).
Click here to read our Test Drive of Control-IQ – diaTribe contributor Kerri Sparling shares how Control-IQ lowered stress and improved time in range.
- Medtronic 7-day infusion set approved in Europe
A new Medtronic extended-wear infusion set has been approved in Europe (it received a CE-Mark). The infusion set lasts for seven days and includes several new components, including a new “H-Cap Connector” that helps infusion site performance, tubing that improves insulin preservative retention, an extended wear adhesive patch, and a new inserter.
The most recent study (with just 21 people) showed that, more than 80% of the time, the extended-wear infusion sets were still working after seven days. This performance is the same as, or better than, the current three-day infusion set after three days of wear. Additionally, the study found that the total daily insulin dose did not increase over the seven days, meaning that insulin delivery efficiency was not changed during the entire period of wear.
According to Medtronic, the new infusion set will be introduced in some countries in early 2021. In the US, the product is currently being tested with 670G users.
- Study shows NovoPen 6 reduces hypoglycemia in children with type 1 diabetes
Dr. Peter Adolfsson from the University of Gothenburg presented encouraging results from a real-world trial of the NovoPen 6, which showed that the device decreased hypoglycemia (low blood sugar) in children with type 1 diabetes under the age of 18. The NovoPen 6 is a connected (“smart”) insulin pen, which automatically records how much insulin was injected. For people on multiple daily injections, this means no logs, no forgetting doses or accidental insulin stacking, and access to the same computer-generated reports that help recognize patterns and optimize therapy as pump users.
The study found:
- Hypoglycemia (defined in the study as blood sugar levels under 54 mg/dl for at least 15 minutes) in children decreased significantly both at night and during the day after 12 months using the smart insulin pen. Before the trial, participants experienced hypoglycemia about once every other day. After 12 months using the connected pen, hypoglycemia episodes fell to about one every third day, a 31% reduction.
- The total daily dose of insulin increased significantly, particularly the basal dose (which rose by 12% after 12 months).
- Time in range and time in hyperglycemia (high blood sugar) were not significantly improved with use of the connected pen.
A previous trial of the NovoPen 6 in adults showed that average time in range improved from 38% to 46% (an increase of 1.9 hours each day), mainly due to a decrease in time spent over 180 mg/dl (49% to 42%, meaning 1.8 hours less time in hyperglycemia each day).
The NovoPen 6 (and kid-friendly Echo Plus) are already approved in Europe, and expected to launch in Europe in 2020.
- Onduo presents stellar data on satisfaction of CGM
Onduo presented reassuring data showing that remotely teaching people to use continuous glucose monitors (CGM) is effective. Onduo’s virtual team of certified diabetes care and education specialists (CDCES) and endocrinologists shipped Dexcom G5 or G6 CGMs to participants with type 2 diabetes. Of the nearly 600 participants, over 95% reported that CGM helped them understand how daily habits and eating affect their blood sugars. Eighty percent of participants also said that they were comfortable with CGM insertion.
Participants also saw significant decreases in A1C. People with a baseline A1C of more than 9.0% saw a 2.6% reduction after ten months, for an overall decrease in A1C of 0.6% (0.6 percentage points).
Notably, 61% of the participants were “previously unfamiliar with CGM,” showing that teaching people to use CGM without prior knowledge is possible. According to Dr. Richard Bergenstal, a collaborator on the study, this data is a strong demonstration that CGM can be shipped to people with type 2 diabetes, they can be trained virtually in how to use the system, and they will benefit significantly from the technology.
- #LanguageMatters discussion on talking about health complications
Two fantastic diabetes advocates and diaTribe contributors, Renza Scibilia and Chris "The Grumpy Pumper" Aldred, led a session about the #LanguageMattersmovement and how healthcare professionals can be more understanding and empathetic when working with people who have diabetes.
Renza and Chris focused on conversations around health complications, and explained that the use of "shock tactics" don’t work. Often, it can cause people to stop listening, or worse, paralyze them into inactivity. Renza said, "We know how serious diabetes is – we're living with this in our bodies every day."
Chris, who was diagnosed with his first complication (a foot ulcer), said that stigma about complications is an enormous weight on the shoulders of people with diabetes. He shared a personal example of an interaction he had with his podiatrist, where she called him “non-compliant” despite his best efforts to avoid complications. He advised an audience filled with healthcare professionals: "In an appointment, your first question should be 'how are you, and how's your family?' because what influences this will influence your diabetes."
Renza and Chris provided some suggestions for healthcare teams:
- Educate without causing fear
- Reframe the language and stop the stigma about diabetes-related complications
- Explain treatment options
- Normalize difficult topics of conversation
- Data on CGM use from the Virtual Specialty Clinic
The Virtual Specialty Clinic (VSC, previously known as Geek Squad) – a virtual diabetes clinic created to expand the use of continuous glucose monitoring (CGM) systems – allows people with to access CGM care from a healthcare professional from the comfort of their own home. VSC led a three-month pilot study of 34 people living with type 1 or type 2 diabetes.
During the study, certified diabetes care and education specialists (CDCES) from Cecilia Health provided three virtual visits (completely online) for participants. The first was an initial training on CGM (Dexcom G6 or FreeStyle Libre): teaching the individual about insertion of the device, how to set alerts, and how to download data. The second was an appointment to review CGM data and provide recommendations after two weeks of use. The third was a visit to discuss tips and tricks to best use CGM after four weeks of use.
On average, the results showed that:
- Participants used CGM 95% of the time.
- Participants had a 1.1% decrease (a 1.1 percentage point reduction) in A1C (from a starting A1C of 8.3%).
- Participants saw an increase in time in range from 48% to 59%.
- Participants with the highest A1C before the trial had the largest A1C reduction over the three months. Those with an A1C above than 9% saw a 1.8% decrease (a 1.8 percentage point reduction) in A1C with CGM; those with an initial A1C above 7.5% saw a 0.4% decrease (a 0.4 percentage point reduction) in A1C.
- Participants expressed increased trust in technology and decreased emotional burden.
The photo below shows that data on time in range increases during the study, in relation to A1C. The blue bar is the time in range before the study started (baseline). The green bar is the time in range over 12 weeks of CGM use.
VSC’s data is encouraging, since it might help people who can’t regularly commute to a clinic get diabetes technology. A larger study to evaluate outcomes in more participants is expected to start later this year.
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