The psychosocial burdens of living with diabetes.

AIM: To better understand the prevalence of self-reported psychosocial burdens and the unmet needs identified by people with diabetes in relation to routine diabetes visits. METHODS: An English language, online survey was distributed via social media, key stakeholder networks, charity and advocacy groups to adults with type 1 diabetes or type 2 diabetes. Survey items were designed by members of the FDA RESCUE Collaborative Community Governing Committee prior to pilot testing with potential participants. Descriptive statistical analyses were conducted, as well as thematic analyses on free-text responses using NVivo v14. RESULTS: Four hundred and seventy-eight participants completed the survey: 373 (78%) had type 1 diabetes, 346 (73%) identified as a woman and 433 (91%) were white. Most participants had experienced self-reported (rather than diagnosed) anxiety and depression (n = 323 and n = 313, respectively), as well as fear of low blood sugars (n = 294), low mood (n = 290) and diabetes-related distress (n = 257). Sixty-eight percent reported that diabetes had negatively affected self-esteem, 62% reported the feelings of loneliness, but 93% reported that friends/family/work colleagues were supportive when needed. Two hundred and seventy-two percent (57%) reported that their diabetes team had never raised the topic of mental health. The overwhelming majority stated that the best thing their diabetes team could do to help was to simply ask about mental well-being, listen with empathy and without judgement, and practice skills to understand psychosocial issues in diabetes. CONCLUSION: Integrating psychosocial discussions and support within routine healthcare visits is crucial to improve outcomes for people with diabetes. Such a biopsychosocial model of healthcare has long been advocated by regulatory bodies.

Transforming Evidence Generation for Drug Label Changes: A Case Study.

Computer Modeling and Simulation (CM&S) provides the opportunity to drastically reduce clinical trial patient burden and advance regulatory decision making. At the suggestion of the US Food and Drug Administration (FDA), MannKind Corporation and Nudge BG submitted an application to the FDA Model-Informed Drug Development (MIDD) pilot program to support a label change for the initial dose of Afrezza® (insulin human), a novel inhalable insulin with a rapid pharmacokinetic and pharmacodynamic profile. The MIDD pilot program demonstrates the FDA's commitment to advancing regulatory science through the adoption of evidence generated by CM&S. A simulation framework was developed based on empirical data. It was used to generate evidence to support the label change. Briefing packages and presentations were prepared for two meetings with the FDA, over a period of four months. The model was thoroughly characterized, determined to be low risk for the question of interest, and submitted along with additional clinical evidence for validation. The FDA found the simulation framework to be helpful in providing insights into the question of interest and provides reasonable glycemic outcome predictions. At the conclusion of the MIDD paired meetings, FDA personnel from the Center for Drug Evaluation and Research review team accepted the simulation and requested additional, traditional clinical evidence to support the proposed label change. In the post-meeting comments, the FDA invited MannKind to submit a proposal for a data package including the CM&S evidence in a Type C meeting for further discussion on the label change. This MIDD pilot experience suggests that CM&S is a credible method for evidence generation. Collaboration between sponsor organizations as well as all stakeholders in the FDA, including proponents of CM&S, can further support regulatory decision-making. The learnings from early participants will allow the program to reach its full potential and thereby ultimately benefit patients, sponsors, and FDA.

Clinical profile, outcomes, and progression to type 2 diabetes among Indian women with gestational diabetes mellitus seen at a diabetes center in south India.

AIM: To describe the clinical profile, maternal and fetal outcomes, and the conversion rates to diabetes in women with gestational diabetes mellitus (GDM) seen at a tertiary care diabetes center in urban south India. MATERIALS AND METHODS: Clinical case records of 898 women with GDM seen between 1991 and 2011 were extracted from the Diabetes Electronic Medical Records (DEMR) of a tertiary care diabetes center in Chennai, south India and their clinical profile was analyzed. Follow-up data of 174 GDM women was available. To determine the conversion rates to diabetes, oral glucose tolerance test (OGTT) was done in these women. Glucose tolerance status postpartum was classified based on World Health Organization (WHO) 2006 criteria. RESULTS: The mean maternal age of the women was 29 ± 4 years and mean age of gestation at first visit were 24 ± 8.4 weeks. Seventy percent of the women had a family history of diabetes. Seventy-eight percent of the women delivered full-term babies and 65% underwent a cesarean section. The average weight gain during pregnancy was 10.0 ± 4.2 kg. Macrosomia was present in 17.9% of the babies, hypoglycemia in 10.4%, congenital anomalies in 4.3%, and the neonatal mortality rate was 1.9%. Mean follow-up duration of the 174 women of whom outcome data was available was 4.5 years. Out of the 174, 101 women who were followed-up developed diabetes, of whom half developed diabetes within 5 years and over 90%, within 10 years of the delivery. CONCLUSIONS: Progression to type 2 diabetes mellitus (T2DM) in Indian women with GDM is rapid. There is an urgent need to develop standardized protocols for GDM care in India that can improve the maternal and fetal outcomes and help prevent future diabetes in women with GDM.

Advancement of the artificial pancreas through the development of interoperability standards.

Despite advancements in the development of the artificial pancreas, barriers in the form of proprietary data and communication protocols of diabetes devices have made the integration of these components challenging. The Artificial Pancreas Standards and Technical Platform Project is an initiative funded by the JDRF Canadian Clinical Trial Network with the goal of developing device communication standards for the interoperability of diabetes devices. Stakeholders from academia, industry, regulatory agencies, and medical and patient communities have been engaged in advancing this effort. In this article, we describe this initiative along with the process involved in working with the standards organizations and stakeholders that are key to ensuring effective standards are developed and adopted. Discussion from a special session of the 12th Annual Diabetes Technology Meeting is also provided.