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Personalization and standardization of PROs across T1D stages
PRO work on the inTandem studies and propose a forward-looking strategy on PROs for DKD
Abstract
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PATIENT-REPORTED OUTCOMES IN THE inTANDEM STUDIES AND PROPOSAL FOR A FORWARD-LOOKING STRATEGY ON PATIENT-REPORTED OUTCOMES FOR DIABETIC KIDNEY DISEASE IN TYPE 1 DIABETES
Presenter: Craig Granowitz
Affiliation: Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA
Background and aims: Patient-reported outcomes (PROs) provide insight into disease burden. In type 1 diabetes (T1D), treatment satisfaction and diabetes distress are associated with glycemic control. In the inTandem 1 and 2 trials, sotagliflozin, a dual inhibitor of SGLT 1 and 2, was associated with improved glucose control and renal-related measures, reduced hypoglycemia, and increased DKA when added to insulin in patients with T1D. PROs were assessed with sotagliflozin in these trials.
Methods: Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and the 2-item Diabetes Distress Scale (DDS2) were evaluated at baseline and 24 weeks in the inTandem trials. PRO results were pooled for both studies and various analyses were performed including changes in the overall scores and in the individual PRO components.
Results: Sotagliflozin 200 and 400 mg significantly improved DTSQ and DDS2 scores overall and for each component compared to placebo. Among patients at high risk of diabetes distress (DDS2 score ≥6) at baseline, significantly more patients receiving sotagliflozin compared to placebo shifted from high to low risk. In blinded exit interviews, improved glycemic stability (ie, lower HbA1c and less hypoglycemia) was frequently cited by more patients on sotagliflozin, which was consistent with the improvements observed in the DTSQs and DDS2.
Conclusions: The inTandem trials showed that improved glycemic control with sotagliflozin reduced disease burden in T1D. Given the renal complications associated with T1D and the beneficial effects of sotagliflozin on renal-related outcomes, it would be of interest to understand if sotagliflozin impacts PROs applied to kidney disease.
Applying PROs to define the future of diabetes technology
Patient-Reported Outcomes Associated with Cell Therapy in T1D
Abstract
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Some patients living with type 1 diabetes (T1D) are participating in clinical trials of cell therapy. As these trials advance, Physician Investigators and clinical trial Sponsors are learning more about outcomes desired and experienced by patients.
Three themes that emerge in this setting are fear of hypoglycemia, a reduction of the burden of daily management of T1D, and a desire for better glycemic control in order to reduce the risk for micro- and macro-vascular complications. Hypoglycemia has a major impact on patients and their behavior,1 and a history and fear of severe hypoglycemia may be a prominent concern driving interest in cell therapy; these issues are even more pronounced for parents and their offspring. For others, cell therapy may be attractive because it does not require daily monitoring. HbA1C control is recognized as important by patients, yet its improvement has to be tempered by reducing hypoglycemia risk and improving glucose time in range, in the context of simplifying the burden of T1D management.
Recent experience suggests that patients with T1D and hypoglycemia unawareness in particular have a strong interest in cell therapy. The interest exists despite the availability of continuous glucose monitoring and advancements in diabetes technological tools. Patients suggest that cell therapy can be successful in several dimensions other than A1C control, and it can be attractive without offering complete insulin independence. Patient personal experiences may not always be related to changes in traditional clinical indicators2 including A1C. Questionnaires used in clinical trials help capture real-time feedback from patients with T1D and can help illuminate both benefits and burdens associated with these interventions. Given the diversity of perspectives and the lack of PRO questionnaires specific to diabetes cell therapy, additional research should include qualitative interviews of patients receiving cell therapy and validation of these instruments. Interviews in the clinical trial setting may be a good supplement for capturing clinically meaningful patient-reported outcomes.
References:
1. K. Khunti, S. Alsifri, R. Aronson, M. Cigrovski Berković, C. Enters-Weijnen, T. Forsén, G. Galstyan, P. Geelhoed-Duijvestijn, M. Goldfracht, H. Gydesen, R. Kapur, N. Lalic, B. Ludvik, E. Moberg, U. Pedersen-Bjergaard and A. Ramachandran. 2017. Impact of hypoglycaemia on patient-reported outcomes from a global, 24-country study of 27,585 people with type 1 and insulin-treated type 2 diabetes. Diabetes research and clinical practice, 130, 121-129.
2. L. Fisher, W. Polonsky, V. Bowyer and D. Hessler. 2020. When patient-reported experience does not match change in clinical outcomes: A perplexing view from the inside of a diabetes distress intervention. Journal of diabetes and its complications, 34(4), 107533.
3. S. N. DuBose, C. Bauza, A. Verdejo, R. W. Beck, R. M. Bergenstal, J. Sherr and H. S. Group. 2021. Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System. Diabetes technology & therapeutics, 23(12), 791-798.