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. 2024 Jul;30(7):2067-2075.
doi: 10.1038/s41591-024-02975-y. Epub 2024 May 3.

Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes

Priya Prahalad  1   2 , David Scheinker  3   4   5   6 , Manisha Desai  7 , Victoria Y Ding  7 , Franziska K Bishop  3   4 , Ming Yeh Lee  3 , Johannes Ferstad  5 , Dessi P Zaharieva  3 , Ananta Addala  3   4 , Ramesh Johari  4   5 , Korey Hood  3   4 , David M Maahs  3   4   8
Affiliations

Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes

Priya Prahalad et al. Nat Med. 2024 Jul.

Abstract

Few young people with type 1 diabetes (T1D) meet glucose targets. Continuous glucose monitoring improves glycemia, but access is not equitable. We prospectively assessed the impact of a systematic and equitable digital-health-team-based care program implementing tighter glucose targets (HbA1c < 7%), early technology use (continuous glucose monitoring starts <1 month after diagnosis) and remote patient monitoring on glycemia in young people with newly diagnosed T1D enrolled in the Teamwork, Targets, Technology, and Tight Control (4T Study 1). Primary outcome was HbA1c change from 4 to 12 months after diagnosis; the secondary outcome was achieving the HbA1c targets. The 4T Study 1 cohort (36.8% Hispanic and 35.3% publicly insured) had a mean HbA1c of 6.58%, 64% with HbA1c < 7% and mean time in the range (70-180 mg dl-1) of 68% at 1 year after diagnosis. Clinical implementation of the 4T Study 1 met the prespecified primary outcome and improved glycemia without unexpected serious adverse events. The strategies in the 4T Study 1 can be used to implement systematic and equitable care for individuals with T1D and translate to care for other chronic diseases. ClinicalTrials.gov registration: NCT04336969 .

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Conflict of interest statement

Competing interests

D.M.M., D.S., P.P., K.H. and R.J. have received support from Stanford MCHRI, Stanford HAI and the NSF. D.S., R.J., D.M.M., K.H., D.P.Z. and A.A. have received funding from the Helmsley Charitable Trust. J.F. has received support from an NSF grant. D.P.Z. has received speakers honoraria from Medtronic Diabetes, Ascensia Diabetes, and Insulet Canada and Dexcom Canada, as well as research support from the ISPAD-Juvenile Diabetes Research Foundation Research Fellowship. D.M.M. has had research support from the NIH and his institution has received research support from Dexcom. D.M.M. has consulted for Abbott, the Helmsley Charitable Trust, Lifescan, Sanofi, Medtronic, Provention Bio, Kriya, Biospex and Bayer. K.H. has received research support from Dexcom for investigator-initiated research, and consultant fees from the Lilly Innovation Center, LifeScan Diabetes Institute and MedIQ. He has also received consulting fees from Sanofi Health and Cecelia Health. D.S. is an adviser to Carta Health. A.A. has received research support from the NIH. The other authors declare no competing interests.

Figures

Fig. 1 |
Fig. 1 |. CONSORT diagram of participants in 4T Study 1.
Consolidated standards of reporting trials for the 4T Study 1.
Fig. 2 |
Fig. 2 |. Participants in 4T Study 1 had lower LOESS based means compared to those in the Pilot 4T Study and the historical cohort.
HbA1c trajectories in the first 12 months of diabetes diagnosis in the historical, Pilot 4T and 4T Study 1 cohorts. Mean HbA1c was higher in the Pilot 4T and 4T Study 1 cohorts. Young people in the 4T Study 1 cohort had the lowest nadir 4 months after diabetes diagnosis and remained on a lower HbA1c trajectory throughout the first year of diabetes diagnosis.
Fig. 3 |
Fig. 3 |. Participants in 4T Study 1 had improved CGM metrics in compared to those in the Pilot 4T Study.
a–f, Scatter plots showing GMI (a), average CGM glucose (b), TIR (c), TITR (d), TBR (e), and time in clinically significant hypoglycemia (f). GMI, mean glucose, TIR and TITR were more favorable in the 4T Study 1 cohort compared to the Pilot 4T cohort. TBR and time in clinically significant hypoglycemia was low in both groups. Error bars represent 95% confidence bands.
Fig. 4 |
Fig. 4 |. Participants in 4T Study 1 had improved TIR throughout the study period compared to those in Pilot 4T.
a,b, Glucose distribution in the Pilot 4T cohort (a) compared to the 4T Study 1 cohort (b).
Fig. 5 |
Fig. 5 |. More youth in 4T Study 1 met HbA1c and GMI targets compared to those in the Pilot 4T Study.
a–d, More young people in the 4T Study 1 achieved HbA1c targets of <7.5% (a) and <7% (b) compared to the Pilot 4T and historical cohorts; this was corroborated in the 4T Study 1 (c) and Pilot 4T (d) cohorts when HbA1c was supplemented with GMI. The number of young people with HbA1c or GMI available at each time point is shown below each bar.
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