Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone

Authors: Thomas Danne, Vijay N Joish, Marion Afonso, Phillip Banks, Sangeeta Sawhney, Pablo Lapuerta, Michael J Davies, John B Buse, Dee Lin, Matthew Reaney, Sophie Guillonneau, Frank J Snoek, Timothy S Bailey, William Polonsky

Abstract

Background: Diabetes-related distress is common among persons affected by diabetes and is associated with suboptimal glycemic control and complications, thus constituting a relevant patient-report outcome (PRO). Improving glycemic control may reduce diabetes distress and improve treatment satisfaction. This post hoc analysis evaluated PRO data for a pooled cohort of adults with type 1 diabetes (T1D) receiving sotagliflozin as adjunct to optimized insulin in the inTandem1 and inTandem2 studies. Methods: Clinically meaningful changes in the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and the two-item Diabetes Distress Scale (DDS2) total and individual scores were examined in the pooled data from the first 24 weeks of the studies. Results: In the cohort of patients with a baseline DTSQs total score ≤32 (∼76% of entire cohort), nearly twice as many patients treated with sotagliflozin 200 (45.9%) or 400 mg (42.3%) experienced a >3-point improvement from baseline versus those treated with placebo (24%). Treatment with sotagliflozin led to statistically significant (P < 0.05) improvements across all DTSQs items. Approximately 42% of all patients were considered to have a high risk of diabetes distress (total DDS2 score ≥6) at baseline following insulin optimization. More patients shifted from high to low risk with sotagliflozin compared with placebo (∼40% vs. 23%; P ≤ 0.0002). The baseline-adjusted difference in DDS2 from placebo was significantly (P < 0.001) reduced by -0.5 and -0.6 for sotagliflozin 200 and 400 mg, respectively. Conclusions: Patients with T1D treated with sotagliflozin in addition to optimized insulin therapy reported meaningful improvements in treatment satisfaction and diabetes distress. NCT02384941 and NCT02421510.

Source: https://pubmed.ncbi.nlm.nih.gov/32721228/

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BDI Monthly Events

June 11Case Consultation
BDI hosts the San Diego-wide, monthly case consultation meeting (for mental health professionals working in the field of diabetes). Contact us at [email protected] if you are in the greater San Diego area and would like further information about this program.
June 20-23ADA 85th Scientific Sessions
It will be a busy time for BDI staff at the American Diabetes Association’s 85th Scientific Sessions (Chicago, IL). Exciting new study results to be presented, new projects to be discussed, and old friends to see.
June 21Above the Bias Panel
At the Abbott Diabetes Care booth at this years ADA Scientific Sessions in Chicago Il, Dr. Guzman, BDI Director of Clinical Education, will be moderating the panel discussion, Above the Bias.
June 22Using CGM in Diabetes Self-Care
At the American Diabetes Association’s 85th Scientific Sessions (Chicago, IL), Dr. Polonsky, BDI President, will be speaking on Tell Me Why—Using CGM to Drive Changes in Diabetes Self-Care. He also serves a co-author on six poster presentations on that day:
June 23EMBARK
At the American Diabetes Association’s 85th Scientific Sessions (Chicago, IL), Dr. Fisher, BDI Research Director, will present Reducing Diabetes Distress Leads to Positive Glycemic Change—Results from the EMBARK Trial
August 8-10TCOYD ONE
August 8 – 10. Taking Control of Your Diabetes (TCOYD) will be hosting the in-person ONE event, an amazing weekend experience here in San Diego for more than 500 people with type 1 diabetes and their loved ones. Dr. Polonsky is honored to be one of the presenters, and we will hope to see many of you there. There are still a few spaces left, so if you’d like to know more, please visit: