Most young people with type 1 diabetes meet HbA1c goal with CGM, remote patient monitoring
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Key takeaways:
- Young people with new-onset type 1 diabetes enrolled in the 4T study received a CGM within 30 days of diagnosis plus remote patient monitoring.
- Of the participants, 64% had an HbA1c of less than 7% at 1 year.
Young people with type 1 diabetes enrolled in a digital health program with early initiation of continuous glucose monitoring plus remote patient monitoring had better glycemic outcomes than historical controls, according to study data.
As Healio previously reported from the pilot 4T (teamwork, targets, technology and tight control) study, an intensive diabetes education program at Stanford University that prescribed CGM within 1 month of a type 1 diabetes diagnosis improved HbA1c for children and adolescents. In a new study from the program published in Nature Medicine, researchers found the intervention continued to lead to improvements in glycemic outcomes with the addition of remote patient monitoring. These improvements persisted when the HbA1c goal was lowered from 7.5% in the pilot study to 7% in the new study.
“Early initiation of diabetes technology combined with a multidisciplinary approach to diabetes management results in tighter glucose control,” David M. Maahs, MD, division chief of pediatric endocrinology at Stanford Medicine Children’s Health, told Healio. “Along with clear targets and expectations, the early use of technologies like CGM lead to an improved quality of life for type 1 diabetes patients in the near term. It also means a stronger likelihood of long-term, sustainable health benefits. This technology has the potential to improve diabetes management for pediatric patients globally.”
Maahs and colleagued enrolled 133 young people aged 1 to 21 years with new-onset type 1 diabetes to participate in the 4T Study 1 from June 13, 2020, to March 5, 2022 (median age at diagnosis, 11 years; 55.6% male; 39.1% white). Remote patient monitoring was offered weekly and prioritized participants who would most benefit based on CGM data. Diabetes education and insulin dose adjustments were sent to participants through electronic health record portal messaging. The primary outcome was change in HbA1c from 4 months to 12 months, and the secondary outcomes were the percentage of participants achieving an HbA1c of less than 7.5% and less than 7% at 12 months. CGM metrics were assessed as exploratory outcomes. Participants in the 4T Study 1 were compared with 135 young people who participated in the pilot 4T trial from July 2018 to June 2020 (median age, 10 years; 52.6% male; 39.3% white), and 272 historical controls who received standard education from June 2014 to December 2016 (median age, 10 years; 50.4% male; 44.1% white).
Most participants reach HbA1c target
From 4 to 12 months, 4T Study 1 participants had less of an increase in HbA1c than historical controls (mean change, 1.44% vs. 1.6%; P < .001). No difference in HbA1c change was seen between 4T Study 1 participants and those enrolled in the pilot 4T study. However, glucose management indicator (GMI) was lower for the 4T Study 1 participants than those who were enrolled in the pilot study throughout the study period. At 12 months, GMI was 7.11% in the 4T Study 1 group and 7.25% for those in the pilot 4T study.
At 12 months, the 4T Study 1 group had a higher time in range, with a glucose between 70 mg/dL and 180 mg/dL, than the pilot study group (68% vs. 63%). Time in hypoglycemia with a glucose of less than 70 mg/dL and less than 54 mg/dL was similar in both groups.
At 12 months, 77% of 4T Study 1 participants achieved an HbA1c target of less than 7.5% compared with 62% in the pilot study and 44% of historical controls. When the HbA1c target was lowered to less than 7%, 64% in the 4T Study 1 met the target compared with 50% in the pilot study and 28% of historical controls.
Maahs said the glycemic improvements observed in 4T Study 1 occurred across all subgroups.
“While there are still small gaps and differences in outcomes for each individual — which is expected across any broad patient population — the benefits were consistent and clear,” Maahs said. “We are seeing a strong embrace of diabetes management technology, and continue to work with multilingual and multicultural research teams to communicate with diverse patient populations. A core value of the program is to provide the best possible care equitably to all patients.”
Moving forward
Maahs said Stanford Medicine Children’s Health has implemented the 4T program into its regular care based on the findings from the pilot study. The institution plans to conduct more studies and make improvements to the program moving forward.
“It will be important to take what we learned in this study and change behaviors across pediatric health care,” Maahs said. “It will require investment in people, equipment, technology, educators and funding, as does any new program. A commitment to getting CGM programs started and understanding how to best fund them will be critical. From there, the conversation shifts to educating patients and building new technologies into workflows. We’re already starting to do this for our patients at Stanford Children’s.”
For more information:
David M. Maahs, MD, can be reached at [email protected].
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