Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Type 1 Diabetes: the Pilot 4T Study

Abstract

Context Youth with type 1 diabetes (T1D) do not meet hemoglobin A1c (HbA1c) targets. Objective To assess HbA1c outcomes in children with new onset T1D enrolled in the Teamwork, Targets, Technology and Tight Control (4T) Study. Method HbA1c levels were compared between the 4T and Historical cohorts. HbA1c differences between cohorts were estimated using locally estimated scatter plot smoothing (LOESS). The change from nadir HbA1c (month 4) to 12 months post-diagnosis was estimated by cohort using a piecewise mixed effects regression model accounting for age at diagnosis, sex, ethnicity, and insurance type. Setting and Participants We recruited 135 youth with newly diagnosed T1D at Stanford Children’s Health. Intervention Starting July 2018, all youth within the first month of T1D diagnosis were offered continuous glucose monitoring (CGM) initiation and remote CGM data review was added in March 2019. Main Outcome Measure HbA1c. Results HbA1c at 6, 9, and 12 months post-diagnosis was lower in the 4T cohort than in the Historic cohort (-0.54%, -0.52%, and -0.58%, respectively). Within the 4T cohort, HbA1c at 6, 9, and 12 months post-diagnosis was lower in those patients with Remote Monitoring than those without (-0.14%, -0.18%, -0.14%, respectively). Multivariable regression analysis showed that the 4T cohort experienced a significantly lower increase in HbA1c between months 4 and 12 (p < 0.001). Conclusions A technology-enabled team-based approach to intensified new onset education involving target setting, CGM initiation, and remote data review significantly decreased HbA1c in youth with T1D 12 months post-diagnosis.

‘Much more convenient, just as effective’: Experiences of starting continuous glucose monitoring remotely following Type 1 diabetes diagnosis

“…This qualitative study is part of a previously reported pragmatic research study 5,14 and is a follow‐up to previously reported qualitative results from in‐person delivery of CGM initiation during the Type 1 diabetes new‐onset period for families of youth with Type 1 diabetes 8 . In brief, the main study delivers a clinical protocol to initiate CGM within 30 days of Type 1 diabetes diagnosis (mean time to CGM initiation = 7 days 14 ) and provides 30 days of CGM supplies while insurance approval is sought. Families receive Dexcom G6 CGM (Dexcom Inc.); the rationale for which has been previously described 8 .…”

Advancements and future directions in the teamwork, targets, technology, and tight control—the 4T study: improving clinical outcomes in newly diagnosed pediatric type 1 diabetes

“…We have previously developed a system for transmitting data from an individual's CGM into our electronic medical records using Apple Health-Kit on iOS devices [ During the Pilot 4T study, remote glucose monitoring was developed and then initiated for the next 89 (out of the 135) children and families who consented to participate in remote data review (i.e., remote monitoring). HbA1c at 12 months postdiagnosis in the Pilot 4T cohort was 0.58% lower than the historic cohort and those Pilot 4T patients receiving remote monitoring had a HbA1c 0.14% lower than patients in the Pilot 4T cohort not receiving remote monitoring at 12 months post-diagnosis [21]. In addition, our 4T program demonstrates that CGM initiation during the new-onset period is feasible and well accepted by youth and their families [31].…”

“…By focusing on the cadence of reviews, study 2 will help to determine whether a more pragmatic and generalizable cadence of reviews yields comparable outcomes while increasing remote data review capacity by clinical team members and testing for non-inferiority. Assessing a more pragmatic cadence of review will define how TIDE can be translated to other clinical settings in a time and cost-efficient manner [21,22]. We will also compare outcomes to historical controls in our program and contemporaneous outcomes in other T1D populations.…”

“…The COVID-19 pandemic has also accelerated the adoption of telehealth for both clinical care and research visits [21]. With the clear demonstration of improved glycemic and quality of life (QoL) outcomes with continuous glucose monitoring (CGM) [22–26], we have made this a priority to support and start CGM for all children, independent of insurance status, early after T1D diagnosis [10,21,27 ▪▪ ]. The aim of this review is to describe the current state of the 4T study as well as the challenges and future directions of this program, especially the second stage of the 4T study…”

Monitoring of paediatric type 1 diabetes

“…More recently, the prospective single-centre 4T (Teamwork, Targets, Technology and Tight Control) Study conducted at a diabetes centre in the USA compared glucose metrics in the first year after diagnosis with historical controls. When CGM was started within the first month of diagnosis together with defined glucose goals, after the nadir at 4 months, HbA1c was lower and there was a low incidence of hypoglycaemia and no episodes of severe hypoglycaemia [33 ▪▪ ].…”