Trial results for a study investigating behavioral interventions for Type 1 Diabetes in emerging adults were posted on ClinicalTrials.gov on 2026-05-05, involving 113 participants. The study explored various behavioral strategies, but key analyses did not show statistically significant changes in Hemoglobin A1c.
Background
Type 1 Diabetes (T1D) is a chronic autoimmune condition requiring lifelong insulin management. A particular challenge exists among older adolescents and emerging adults (16-21) with T1D, a demographic often characterized by chronic poor metabolic control. Behavioral interventions are crucial for this age group to support self-management and improve health outcomes. The intervention tested in this study was grounded in self-determination theory, which posits that self-directed, competent, and supported diabetes management leads to better self-care consistency.
Trial design
This completed study, designated as Phase NA, enrolled 113 participants with Diabetes Mellitus, Type 1. The trial investigated the efficacy of multi-component behavioral interventions aimed at improving metabolic control. Interventions included a Question Prompt List (QPL), a Motivation Enhancement System (MES), Text Message Reminders (TXT), and combinations thereof, compared against Standard Medical Care. The primary outcomes were not explicitly detailed in the posted results, but key measurements focused on Hemoglobin A1c levels.
Key results
The trial reported Hemoglobin A1c (Percentage (%) of glycated hemoglobin) measurements for various intervention groups:
- Question Prompt List (QPL): Mean of 9.6 (Standard Deviation 2.0) and Mean of 10.0 (Standard Deviation 3.3)
- Motivation Enhancement System (MES): Mean of 9.8 (Standard Deviation 2.5) and Mean of 10.2 (Standard Deviation 2.8)
- Text Message Reminders (TXT): Mean of 8.5 (Standard Deviation 1.1) and Mean of 8.4 (Standard Deviation 1.0)
- QPL & MES: Mean of 10.9 (Standard Deviation 2.1) and Mean of 10.3 (Standard Deviation 2.7)
- QPL & TXT: Mean of 9.6 (Standard Deviation 2.2)
- MES & TXT: Mean of 9.1 (Standard Deviation 1.6)
- MES, QPL & TXT: Mean of 9.6 (Standard Deviation 2.7)
- Standard Medical Care: Mean of 9.7 (Standard Deviation 1.9)
Key analyses evaluating within-group changes in Hemoglobin A1c from baseline reported the following mean or median differences, none of which reached statistical significance (p > 0.05):
- For within-group change in HbA1c from Baseline to 3-month, a Mean Difference (Final Values) of 0.42 was observed (t-test, 1 sided; p-value 0.219).
- For within-group change in HbA1c from Baseline to 6-month, a Mean Difference (Final Values) of 0.9 was observed (t-test, 1 sided; p-value 0.07).
- For within-group change in HbA1c from Baseline to 3-month, a Mean Difference (Final Values) of 0.38 was observed (t-test, 1 sided; p-value 0.06).
- For within-group change in HbA1c from Baseline to 6-month, a Mean Difference (Final Values) of 0.31 was observed (t-test, 1 sided; p-value 0.09).
- For within-group change in HbA1c from Baseline to 3-month, a Mean Difference (Final Values) of -0.3 was observed (t-test, 1 sided; p-value 0.13).
- For within-group change in HbA1c from Baseline to 6-month, a Median Difference (Final Values) of 0.07 was observed (t-test, 1 sided; p-value 0.44).
What this means
The trial results suggest that the multi-component behavioral interventions, including Question Prompt Lists, Motivation Enhancement Systems, and Text Message Reminders, did not achieve statistically significant improvements in Hemoglobin A1c levels for older adolescents and emerging adults with Type 1 Diabetes. While various HbA1c measurements were recorded for different groups, the key analyses of within-group changes from baseline did not demonstrate a significant impact. This indicates that these specific intervention strategies, as implemented, may not be sufficient to improve metabolic control in this patient population, highlighting a need for further research into more effective behavioral approaches.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04066959, titled "Improving Diabetes in Emerging Adulthood", were posted on 2026-05-05 on clinicaltrials.gov.