Underrepresentation of Diverse Populations and Glycemic Outcomes in Major Clinical Trials of Automated Insulin Delivery.

Individuals with type 1 diabetes of minoritized race-ethnicities and low-socioeconomic status (SES) do not access nor use automated insulin delivery (AID) technology at equal rates compared to their non-Hispanic White (NHW) and high SES counterparts. Using four AID trials (n=292), we ran linear mixed models to compare glycemic outcomes using race/ethnicity, education, and income. These trials overrepresented NHW (83%), high-income (91%), and highly educated (86%) populations. By education, participants with 180 mg/dL: 46.2% vs. 34.5% (p<0.001). These differences disappeared following AID use. By race/ethnicity and income groups, there were no differences in baseline glycemic control. While baseline glycemic control tended to be worse for underrepresented populations, AID glycemic efficacy was approximately equivalent. These results suggest improving accessibility to AID could equalize glycemic outcome disparities

Characteristics of adults with type 1 diabetes and treatment-resistant problematic hypoglycaemia: a baseline analysis from the HARPdoc RCT

Aims/hypothesis Problematic hypoglycaemia still complicates insulin therapy for some with type 1 diabetes. This study describes baseline emotional, cognitive and behavioural characteristics in participants in the HARPdoc trial, which evaluates a novel intervention for treatment-resistant problematic hypoglycaemia. Methods We documented a cross-sectional baseline description of 99 adults with type 1 diabetes and problematic hypoglycaemia despite structured education in flexible insulin therapy. The following measures were included: Hypoglycaemia Fear Survey II (HFS-II); Attitudes to Awareness of Hypoglycaemia questionnaire (A2A); Hospital Anxiety and Depression Index; and Problem Areas In Diabetes. k-mean cluster analysis was applied to HFS-II and A2A factors. Data were compared with a peer group without problematic hypoglycaemia, propensity-matched for age, sex and diabetes duration (n = 81). Results The HARPdoc cohort had long-duration diabetes (mean ± SD 35.8 ± 15.4 years), mean ± SD Gold score 5.3 ± 1.2 and a median (IQR) of 5.0 (2.0–12.0) severe hypoglycaemia episodes in the previous year. Most individuals had been offered technology and 49.5% screened positive for anxiety (35.0% for depression and 31.3% for high diabetes distress). The cohort segregated into two clusters: in one (n = 68), people endorsed A2A cognitive barriers to hypoglycaemia avoidance, with low fear on HFS-II factors; in the other (n = 29), A2A factor scores were low and HFS-II high. Anxiety and depression scores were significantly lower in the comparator group. Conclusions/interpretation The HARPdoc protocol successfully recruited people with treatment-resistant problematic hypoglycaemia. The participants had high anxiety and depression. Most of the cohort endorsed unhelpful health beliefs around hypoglycaemia, with low fear of hypoglycaemia, a combination that may contribute to persistence of problematic hypoglycaemia and may be a target for adjunctive psychological therapies

Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes

<p>Abstract</p> <p>Background</p> <p>To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia.</p> <p>Methods</p> <p>An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia.</p> <p>Results</p> <p>112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0).</p> <p>Conclusion</p> <p>We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.</p

Consensus Recommendations for the Use of Automated Insulin Delivery (AID) Technologies in Clinical Practice

International audienceThe significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past six years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage

Diabetes Just Tends to Take Over Everything : Experiences of Support and Barriers to Diabetes Management for Pregnancy in Women With Type 1 Diabetes.

To optimize clinical outcomes, women with type 1 diabetes are advised to consistently achieve blood glucose levels in their target range before becoming pregnant. However, following this recommendation can be clinically and psychologically challenging for patients. We explored women\u27s experiences of pregnancy-related diabetes management and any barriers and support systems affecting their self-management. Fifteen semi-structured telephone interviews were conducted with a nationwide sample. Interviews focused on women\u27s perceptions of barriers hindering pregnancy-related diabetes management and support systems facilitating their self-management. Audio recordings were analyzed using inductive thematic analysis. Results indicated significant impairment of psychological health and overall quality of life in women with type 1 diabetes who were pregnant or planning pregnancy. Most participants reported a lack of support and empathetic engagement from their health care team, which affected their clinical management. Guilt and concerns about high blood glucose levels, constant pressure to meet glucose targets, and difficult interactions with health care professionals were a few of the primary themes with regard to barriers to optimal management. Patient-centered programs that provide effective clinical and psychosocial support for women who are preparing for pregnancy with preexisting diabetes are urgently needed so that these women feel adequately supported and empowered to undertake pregnancy