Day 2 & 3 Highlights: ADA Scientific Sessions 2021

By Eliza Skoler, Matthew Garza, and Julia Kenney

The American Diabetes Association’s 81st Scientific Sessions is going strong. Updates from days two and three include promising Omnipod 5 results, Medtronic’s seven-day infusion set, and Control-IQ real-world data.

Days two and three of ADA’s Scientific Sessions – the biggest diabetes conference of the year! – brought big news and interesting research at this year’s virtual gathering. Click to read our coverage from day one here.

Click to jump down:

• Omnipod 5 AID system is safe and effective for people with type 1 diabetes of all ages

• New results on Medtronic’s Extended-Wear Infusion Set

• Control-IQ leads to major Time in Range increases in older adults with type 1 diabetes

Omnipod 5 AID system is safe and effective for people with type 1 diabetes of all ages

Promising results from three pivotal studies showed that Omnipod 5, Insulet’s new automated insulin delivery (AID) system, can help people of all ages manage type 1 diabetes. Among children, teens, and adults with type 1 diabetes, the system is found to be safe and easy to use at three months – and early results from the 12-month extension phases of the trials show that the glucose effects can be sustained for six months.

The table summarizes three-month results from all three trials, and we explain the data in more detail below.

Dr. Jennifer Sherr presented three-month pivota data from the young pediatrics trial (children ages two to six):

• A1C was reduced from 7.4% at the start of the trial to 6.9% after three months of Omnipod 5 usage.

  • ​The majority of the children (54%) achieved an A1C below 7% at the end of the study, compared to 31% of the participants who had an A1C below 7% at baseline.

  • Twelve of the 80 participants were on multiple daily injections of insulin at baseline.

• Time in Range (TIR) improved by 2.6 hours per day using Omnipod 5, from 57% to 68% TIR. This was largely driven by less time spent in hyperglycemia – time with glucose levels above 180 mg/dl fell by 2.4 hours per day, from 39% to 30%.

• Overnight Time in Range (defined as midnight to 6am) increased significantly from 58% to 81%. That translates to an additional 1.4 hours each night spent in range. This came from a reduction in the time spent with glucose levels above 180 mg/dl, which fell from 38% to just 17%.

  • The percentage of parents or caregivers who reported “very good” or “fairly good” sleep quality increased from 65% to 90% with Omnipod 5; on the other end, the percentage reporting “very bad” sleep quality went from 9% to 0%.

• No severe hypoglycemia or DKA events were recorded in the three-month study – the Omnipod 5 system was shown to be safe for this group of young children.

Dr. Korey Hood presented quality of life outcomes from the Omnipod 5 trial in children and teenagers (ages 6 to 18). The results, reported by participants and one parent before starting Omnipod 5 and after three months of use, showcased the value of AID systems for reducing the burden of diabetes and improving quality of life.

• Diabetes distress decreased significantly with Omnipod 5 for the 250 participants across all groups – children, parents of children, teens, and parents of teens. This was exhibited by lower scores (which indicate lower distress) in the results from the Problem Areas in Diabetes (PAID) survey that measures diabetes-specific emotional distress.

• Among parents of children, hypoglycemia confidence (feeling comfortable with avoiding and being able to avoid low blood sugar problems) increased. This was exhibited by higher scores (which indicate higher confidence) in the results from the Hypoglycemia Confidence Scale that measures how comfortable people feel staying safe from hypoglycemic problems.

• In terms of sleep, parents and caregivers of children saw significant improvements in sleep duration, sleep disturbances, and overall sleep quality. This was exhibited by lower scores (which indicate better sleep) in the results from the Pittsburgh Sleep Quality Index that measures how sleep quality and distrubances.

• Mental well-being increased most among parents of children – the group that had the highest baseline rates of diabetes distress and low mental well-being. This was exhibited by higher scores (which indicate better mental well-being) in the results from the World Health Organization 5 that measures psychological well-being.

Following the initial three-month pivotal results from Omnipod 5, 92% of adults and adolescents, and 99% of children, chose to continue using Omnipod 5 in a one-year extension phase of the trial. After six months of Omnipod 5 use:

• A1C reductions were maintained.

  • Average A1C for children improved from 7.7% to 7.0% during the first three months of the trial, and was 6.9% after six months.

  • Average A1C for adolescents and adults fell from 7.2% to 6.8% during the first three months, and was 6.7% after six months.

  • 54% of the children and 73% of the adolescents and adults recorded an A1C below 7% after six months of Omnipod 5.

• Time in Range improvements were also maintained.

  • Among children, Time in Range improved from 52% to 68% during the first three months; after six months, TIR was 67%.

  • For adolescents and adults, Time in Range improved from 65% to 74% during the first three months; after six months, TIR was 73%.

Omnipod 5 has been submitted to the FDA for people ages 14 and older in the US, and will hopefully become available later this year.

New results on Medtronic’s Extended-Wear Infusion Set

Exciting new results were shared from the US pivotal trial for Medtronic’s Extended-Wear Infusion Set. The study enrolled 259 people with type 1 diabetes using the MiniMed 670G system and found:

• The extended infusion set had a seven-day survival rate of 75%. That means that 75% of the time users were able to wear the infusion set for a full seven days. As a comparison, Medtronic’s two-day or three-day infusion sets had a survival rate around 67% for two or three days which means only 67% of the time does the set last the full two or three days.

• Rates of device failure were low. Of more than 3,000 extended-wear sessions in the trial, there were only eight device-related cases of hyperglycemia and no cases of device-related hypoglycemia or DKA.

• Users saw a slight improvement in glucose management. Average Time in Range improved from 72% using the control infusion sets to 74% with Extended-Wear Infusion Set (that’s about 36 more minutes per day spent in range).

• People reported being very satisfied with the new infusion set, with greater convenience of use, ease of insertion, and comfort of wear.

Medtronic’s Extended-Wear Infusion Set is approved in Europe and launched in Finland. In the US, the device has been submitted to the FDA.

Control-IQ leads to major Time in Range increases in older adults with type 1 diabetes

Dr. Elena Toschi presented an analysis of real-world data from older adults with type 1 diabetes who started using the Control-IQ automated insulin delivery system. The sample included data from 39 adults with an average age of 70 years and a baseline glucose management indicator (GMI) of 6.9%. Researchers compared CGM data from two weeks prior to starting Control-IQ with data from three months after initiating the automated insulin delivery system. Participants’ Time in Range (TIR) increased from 64% to 87%. This is about 5.5 more hours spent in range each day!

• Time in hyperglycemia (above 180 mg/dL) fell from 29% to 18%, about 2.6 fewer hours per day.

• Time in hypoglycemia (below 70 mg/dL) fell from 2.8% to 1.9%, a decrease of almost 30 minutes.

• GMI fell slightly to 6.8%, and glycemic variability fell from 34% to 28%. Some may wonder why the GMI change was only 0.1 percentage point given the impressive Time in Range imporvements – we are checking this but are assuming that the lower time in hypoglycemia means less time in the lower glucose level range correspond to only a small reduction in GMI. 

All of these adults had prior experience with continuous glucose monitoring and insulin pumps.