Acceptability and experiences of real-time continuous glucose monitoring in adults with type 2 diabetes using insulin: a qualitative study.

Aims: To explore the lived experiences of initiating real-time continuous glucose monitoring (rt-CGM) use in individuals with type 2 diabetes using insulin. Methods: Twelve semi-structured interviews were conducted amongst individuals with type 2 diabetes taking insulin who were enrolled in the 2GO-CGM randomised controlled trial and had completed 3 months of rtCGM. Interviews were transcribed verbatim and analysed to identify common themes regarding their experiences. Results: The interviews revealed three key themes: i) rtCGM as a facilitator of improved health behaviours; ii) the acceptability of rtCGM systems compared to capillary blood glucose testing; and iii) barriers to the continual usage of rtCGM technology - including: connection difficulties, longevity of the sensors, and local cutaneous reactions to the sensor adhesive. Conclusion: Adults on insulin with type 2 diabetes find rtCGM systems widely acceptable, and easier to engage with than traditional self-monitoring of capillary blood glucose. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01403-9.

Protocol for a prospective, multicenter, parallel-group, open-label randomized controlled trial comparing standard care with Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control: the CO-PILOT trial.

Purpose: Advanced hybrid closed loop (AHCL) systems have the potential to improve glycemia and reduce burden for people with type 1 diabetes (T1D). Children and youth, who are at particular risk for out-of-target glycemia, may have the most to gain from AHCL. However, no randomized controlled trial (RCT) specifically targeting this age group with very high HbA1c has previously been attempted. Therefore, the CO-PILOT trial (Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control) aims to evaluate the efficacy and safety of AHCL in this group. Methods: A prospective, multicenter, parallel-group, open-label RCT, comparing MiniMed™ 780G AHCL to standard care (multiple daily injections or continuous subcutaneous insulin infusion). Eighty participants aged 7-25 years with T1D, a current HbA1c ≥ 8.5% (69 mmol/mol), and naïve to automated insulin delivery will be randomly allocated to AHCL or control (standard care) for 13 weeks. The primary outcome is change in HbA1c between baseline and 13 weeks. Secondary outcomes include standard continuous glucose monitor glycemic metrics, psychosocial factors, sleep, platform performance, safety, and user experience. This RCT will be followed by a continuation phase where the control arm crosses over to AHCL and all participants use AHCL for a further 39 weeks to assess longer term outcomes. Conclusion: This study will evaluate the efficacy and safety of AHCL in this population and has the potential to demonstrate that AHCL is the gold standard for children and youth with T1D experiencing out-of-target glucose control and considerable diabetes burden. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 November 2022 (ACTRN12622001454763) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1284-8452). Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01397-4.

Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial.

Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control. Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4-13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%-12.2% [58-110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks. Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: -0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97-6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70-180 mg/dL) was reduced with isCGM -6.4% (10.6 to -4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks. Conclusions: For children aged 4-13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

Knowledge, safety, and impact of alcohol consumption in young adults with type 1 diabetes mellitus: a qualitative study.

PURPOSE: To explore the lived experiences of alcohol consumption among young adults with type 1 diabetes. METHODS: Fourteen semi-structured interviews were conducted amongst young adults aged between 18 and 25 years, inclusive, with type 1 diabetes and experience consuming alcohol. Interviews were transcribed verbatim and analysed to identify common themes regarding their experiences. RESULTS: The interviews confirmed that young adults with type 1 diabetes engage in social, and occasionally excessive, drinking behaviour. Furthermore, the interviews revealed four key themes: (i) Several sources contribute to a widely inconsistent understanding of the impact and management of alcohol consumption; (ii) Perceived inconvenience of maintaining healthy glycaemic control whilst drinking socially; (iii) Engagement in proactive strategies for harm reduction occurred when convenient; and (iv) Impact of modern diabetes technology in overcoming previous burdens and promoting glycaemic safety. CONCLUSION: Young adults with type 1 diabetes continue to need anticipatory education surrounding safe alcohol consumption and behaviours, as well as ongoing support and encouragement to ensure engagement with traditional self-management tasks. Significant alcohol-diabetes related safety issues, particularly hypoglycaemia do occur, and were captured within this small sample and study. Diabetes technology has an important complementary role along with education and tailored support strategies to support health and safe glucose control during alcohol consumption.

The OPTIMISE study protocol: a multicentre optimisation trial comparing continuous glucose monitoring, snacking habits, sleep extension and values-guided self-care interventions to improve glucose time-in-range in young people (13-20 years) with type 1 diabetes.

Purpose: The OPTIMISE study uses a Multiphase Optimisation Strategy (MOST) to identify the best combination of four interventions targeting key diabetes self-care behaviours for use in clinical practice to improve short-term glycaemic outcomes. Methods: This 4-week intervention trial will recruit 80 young people (aged 13-20 years) with type 1 diabetes ≥ 6 months duration), and pre-enrolment HbA1c ≥ 58 mmol/mol (7.5%) in the prior 6 months. Both main intervention and interaction effects will be estimated using a linear regression model with change in glucose time-in-range (TIR; 3.9-10.0 mmol/L) as the primary outcome. Participants will be randomised to one of 16 conditions in a factorial design using four intervention components: (1) real-time continuous glucose monitoring (CGM), (2) targeted snacking education, (3) individualised sleep extension, and (4) values-guided self-care goal setting. Baseline and post-intervention glucose TIR will be assessed with blinded CGM. Changes in self-care (snacking behaviours, sleep habits and duration, and psychosocial outcomes) will be assessed at baseline and post-intervention to determine if these interventions impacted behaviour change. Discussion: The study outcomes will enable the selection of effective and efficient intervention components that increase glucose TIR in young people who struggle to achieve targets for glycaemic control. The optimised intervention will be evaluated in a future randomised controlled trial and guide the planning of effective clinical interventions in adolescents and young adults living with type 1 diabetes. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 7 October 2020 (ACTRN12620001017910) and the World Health Organisation International Clinical Trails Registry Platform on 26 July 2020 (Universal Trial Number WHO U1111-1256-1248).

Use of intermittently scanned continuous glucose monitoring in young people with high-risk type 1 diabetes-Extension phase outcomes following a 6-month randomized control trial.

AIMS: To describe the impact of a 12-month intervention using intermittently scanned continuous glucose monitoring (isCGM) on glycaemic control and glucose test frequency in adolescents and young adults with type 1 diabetes (T1D) and high-risk glycaemic control (HbA1c ≥75 mmol/mol [≥9.0%]). METHODS: In total, 64 young people (aged 13-20 years, 16.6 ± 2.1 years; 48% female; 41% Maori or Pacific ethnicity; mean diabetes duration 7.5 ± 3.8 years) with T1D were enrolled in a 6-month, randomized, parallel-group study comparing glycaemic outcomes from the isCGM intervention (n = 33) to self monitoring blood glucose (SMBG) controls (n = 31). In this 6-month extension phase, both groups received isCGM; HbA1c , glucose time-in-range (TIR), and combined glucose test frequency were assessed at 9 and 12 months. RESULTS: At 12 months, the mean difference in HbA1c from baseline was -4 mmol/mol [-0.4%] (95% confidence interval, CI: -8, 1 mmol/mol [-0.8, 0.1%]; p = 0.14) in the isCGM intervention group, and -7 mmol/mol [-0.7%] (95% CI: -16, 1 mmol/mol [-1.5, 0.1%]; p = 0.08) in the SMBG control group. No participants achieved ≥70% glucose TIR (3.9-10.0 mmol/L). The isCGM intervention group mean rate of daily glucose testing was highest at 9 months, 2.4 times baseline rates (p < 0.001), then returned to baseline by 12 months (incidence rate ratio = 1.4; 95% CI: 0.9, 2.1; p = 0.091). CONCLUSIONS: The use of isCGM in young people with high-risk T1D resulted in transient improvements in HbA1c and glucose monitoring over a 9-month time frame; however, benefits were not sustained to 12 months.