Cost-Utility Analysis of Control-IQ Technology Relative to Conventional Insulin Therapy in Adults with Type 1 Diabetes.

Insulin Pumps

I nternational experts in the fields of diabetes, diabetes technology, endocrinology, and pediatrics gathered for the 5 th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond.The aim of this meeting was to continue setting up a global network of experts in this field and provide an international platform for exchange of ideas to improve life for people with diabetes.In line with previous editions, the 2012 meeting comprised a comprehensive scientific program, parallel interactive workshops, pros and cons debates, and a keynote.All these discussions were intended to help identifying gaps and areas where further scientific work and clinical studies are needed.

Background and Aims: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems such as the MiniMed™ 780G have been shown to result in substantial improvements in disease management in people living with type 1 diabetes. The aim of the analysis was to assess the cost utility of the MiniMed 780G system compared with intermittently scanned continuous glucose monitoring (is-CGM) and multiple daily insulin injections (MDI) in people living with type 1 diabetes in France, to estimate the incremental cost-utility ratio (ICUR) and inform decision-making. Methods: The analysis was performed using the CORE Diabetes Model (version 9.5) and clinical input data were sourced from a randomized controlled trial, with glycated hemoglobin reductions of 1.54% (16.8 mmol/mol) and 0.2% (2.18 mmol/mol) assumed for the MiniMed 780G arm and is-CGM + MDI arm, respectively. The analysis was conducted from a national payer perspective over a 40-year time horizon; future costs and clinical outcomes were discounted at 2.5% per annum. Results: In the base case analysis, use of the MiniMed 780G system was associated with a mean gain in quality-adjusted life expectancy of 2.26 quality-adjusted life years (QALYs) compared with is-CGM + MDI (16.33 QALYs vs. 14.07 QALYs), while mean direct lifetime costs were EUR 78,509 higher (EUR 215,037 vs. EUR 136,528), resulting in an ICUR of EUR 34,732 per QALY gained. Findings from sensitivity analyses showed that analyses were robust to changes in assumptions in most input parameters. Conclusions: In people with type 1 diabetes in France not achieving glycemic target levels at baseline, the use of the MiniMed 780G system was projected to lead to substantial improvements in quality-adjusted life expectancy compared with continued use of is-CGM + MDI, with an ICUR of EUR 34,732 per QALY gained.

Real-World Diabetes Technology: Overcoming Barriers and Disparities.

BackgroundInsulin therapy is required to prevent diabetic ketoacidosis and to optimise blood glucose levels in order to to minimise vascular complications in all Children and Young People with Type 1...

The primary goal of managing type1 diabetes mellitus (T1D) is to achieve glycemic control and prevent both acute and chronic complications. In recent years, automated insulin delivery (AID) systems, such as the 780G AID system, have significantly improved glycemic control and patient safety. Despite being the most advanced treatment option, AID initiation is often delayed until the honeymoon stage (partial remission phase). This study evaluated the impact of initiating MiniMed™ 780G at diagnosis on metabolic control and glycemic metrics in children newly diagnosed with T1D. It compares early AID initiation with continuous glucose monitoring (CGM) and multiple daily injection (MDI) therapy over a 1-year follow-up period. This retrospective study included children and adolescents (age range 0.87-17.72years) newly diagnosed with T1D between January 2023 and August 2024. Ten patients who were initiated on AID therapy at diagnosis were included, with eight patients completing a 1-year follow-up. Data from these eight patients and seven patients on CGM + MDI therapy were analyzed at baseline and at 3, 6, and 12months. The mean age at diagnosis was 6.98 ± 3.22years (0.87-9.82) for the AID group and 9.77 ± 4.89years (3.70-17.72) for the CGM + MDI group (p = 0.14). The AID system was initiated at an average of 3.33 ± 7.73days (2-23) after diagnosis, while sensor use in the CGM + MDI group began an average of 17.37 ± 8.86days (1-29) after diagnosis. At 12months, mean hemoglobin A1c (HbA1c) was 6.10% (43 mmol/mol) in the AID group compared with 7.73% (61 mmol/mol) in the CGM + MDI group. Time in range (TIR) was 79.0% vs. 50.7%, and time above range (TAR) was 13.4% vs. 30.7%, based on 2-week CGM data prior to the 12-month visit (p = 0.02, p = 0.009, p = 0.02). No case of diabetic ketoacidosis or severe hypoglycemia was reported during the follow-up period. This study highlights the potential benefits of initiating AID therapy at the time of diagnosis, offering novel insights into its safety and efficacy in the early management of T1D. These findings suggest that early initiation of AID therapy at the time of diagnosis is feasible and may improve glycemic outcomes.

Journal of Diabetes NEWS

OBJECTIVETo compare use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injection (MDI) therapy versus continuous subcutaneous insulin infusion (CSII) therapy for 6 months.RESEARCH DESIGN AND METHODSSixty type 1 diabetic adults with similar baseline characteristics, using either MDI (n = 30) or CSII (n = 30) therapy, were enrolled in this 6-month prospective study. Subjects were instructed to wear the DexCom SevenPLUS continuous glucose monitor at all times throughout the study. All subjects were initially blinded from the continuous glucose monitoring (CGM) glucose data. After 4 weeks of blinded CGM use, the CGM was unblinded, making glucose data available to the patient. The CGM remained in the unblinded state for the remainder of the study (20 weeks). Clinic visits occurred every 4 weeks, at which time A1C values were collected and CGM data were downloaded.RESULTSMean baseline (± SD) A1C was 7.61 (± 0.76) and 7.63 (± 0.68) for CSII and MDI, respectively (P > 0.05). Without any significant therapy change, A1C decrease at 12 weeks was similar in both groups (P = 0.03). When compared with the blinded phase, unblinded use of CGM was associated with similar but significant reductions in glycemic control and variability parameters. In addition, both therapy groups had similar changes in mean glucose and glucose variability indexes at 3 and 6 months (ITT analysis, P > 0.05). Predefined per protocol analysis (sensor use at least 6 days/week) showed greater improvement in time spent in target range glycemia, 3.9–10.0 mmol/L (70–180 mg/dL), in the CSII group.CONCLUSIONSWe conclude that CGM provides similar benefits in glucose control for patients using MDI or CSII therapy.

Multiple daily injection (MDI) therapy of bolus insulin aspart and basal insulin glargine was compared with continuous subcutaneous insulin infusion (CSII) with aspart in type 1 diabetic patients previously treated with CSII. One hundred patients were enrolled in a randomized, multicenter, open-label, crossover study. After a 1-week run-in period with aspart by CSII, 50 subjects were randomly assigned to MDI therapy (aspart immediately before each meal and glargine at bedtime) and 50 subjects continued CSII. After 5 weeks of the first treatment, subjects crossed over to the alternate treatment for 5 weeks. During the last week of each treatment period, subjects wore a continuous glucose monitoring system for 48-72 h. Mean serum fructosamine levels were significantly lower after CSII therapy than after MDI therapy (343 +/- 47 vs. 355 +/- 50 micromol/l, respectively; P = 0.0001). Continuous glucose monitoring profiles over a 24-h time period showed that glucose exposure was 24 and 40% lower for CSII than MDI as measured by area under the curve (AUC) glucose >/=80 mg/dl (1,270 +/- 742 vs. 1,664 +/- 1,039 mg . h . dl(-1); P < 0.001) and AUC glucose >/=140 mg/dl (464 +/- 452 vs. 777 +/- 746 mg . h . dl(-1), CSII vs. MDI, respectively; P < 0.001). Similar percentages of subjects reported hypoglycemic episodes (CSII: 92%, MDI: 94%) and nocturnal (12:00 a.m. to 8:00 a.m.) hypoglycemic episodes (CSII: 73%, MDI: 72%). Major hypoglycemia was infrequent (CSII: two episodes, MDI: five episodes). In a trial of short duration, CSII therapy with insulin aspart resulted in lower glycemic exposure without increased risk of hypoglycemia, as compared with MDI with insulin aspart and glargine.

The impressive progress achieved in recent years in diabetes technologies has made diabetes technological devices such as continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) a significant part of diabetes treatment. Many studies conducted in recent years emphasized the advantages of using these technologies. The concept of the “human factor” in diabetes technologies as discussed in this chapter has several different aspects. First, it can refer to the way patients are satisfied with the use of the device and whether it is perceived convenient or inconvenient. For example, is the device perceived as “user friendly” (easy to learn and to operate, comfortable, does not cause many hassles). Second, there is the issue of effectiveness of the technology as it relates to their day-to-day diabetes management. For example, there is an improvement in glycemic control when one diabetes treatment regimen is compared to another (i.e., CSII vs. multiple daily injections (MDI)). Those two fundamental aspects may have different meanings for different groups. For example, different age groups (toddlers, children, adolescents, young adults, adults, and older people) can see different advantages and disadvantages in technological devices. The feasibility and utility of technological devices also need to fit the environments in which they will be used, such as school, the work place, and/or home. Specific subgroups such as diabetic youth with eating disorders can have unique interactions with diabetes technologies. In addition, diabetes technologies can be used as a measurement device, providing more rich and accurate data about patients' self-care that can contribute to our understanding of concepts such as adherence and satisfaction, and they can provide measurement tools to assess how glycemic control can effect cognition and intelligence. The present chapter will review articles published in the last year that have studied some of these issues.

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference 22‐25 February 2023 I Berlin &amp; Online

Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial

ObjectiveRegarding the effects and practical application of insulin pumps on patients with type 1 diabetes mellitus (T1DM), the real-world evidence is limited especially concerning the incidence of hypoglycemia. This study aimed to compare the efficacy of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy on glycemic metrics evaluated by retrospective continuous glucose monitoring (CGM) in Chinese patients with T1DM.MethodsIn total, 362 T1DM Chinese patients from the outpatient department of the Second Xiangya Hospital, Central South University, who underwent intensive insulin therapy and used a retrospective CGM system were included in this retrospective cross-sectional study. Comprehensive analysis of clinical and biological features and retrospective CGM derived-metrics was performed on the 362 enrolled T1DM patients who underwent CSII (n = 61) or MDI (n = 301) therapy (defined as 4 or more insulin injections per day).ResultsOur findings demonstrated that patients who underwent CSII therapy, compared with those who received MDI therapy, had lower levels of hemoglobin A1c (HbA1c) and fasting blood glucose; moreover, CSII therapy was associated with better glycemic outcomes in terms of increasing time in range (TIR), decreasing time above range (TAR), and achieving CGM-associated targets of TIR ≥70% and TAR <25%. However, patients who underwent CSII therapy did not experience decreasing time below range (TBR), achieving CGM-associated targets of TBR <4%, and reduction of the risk of hypoglycemia as evidenced by comparing TBR and low blood glucose index (LBGI) between the two treatment regimens. The parameters of glycemic variability, such as standard deviation of glucose (SD), mean amplitude glycemic excursion (MAGE), and large amplitude glycemic excursion (LAGE) in T1DM patients who underwent CSII therapy outperformed.ConclusionOur results provided further evidence that CSII therapy is safe and effective for management of Chinese T1DM patients, which was confirmed by a lower HbA1c level and better CGM-derived metrics but no demonstration of improvment in the risk of hypoglycemia. To achieve more satisfactory glycemic outcomes through the utilization of CSII therapy for Chinese T1DM patients, a strong physician-patient relationship is essential.

Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

Aims/hypothesisEvidence for the effectiveness of interstitial glucose monitoring in individuals with type 1 diabetes using multiple daily injection (MDI) therapy is limited. In this pre-specified subgroup analysis of the Novel Glucose-Sensing Technology and Hypoglycemia in Type 1 Diabetes: a Multicentre, Non-masked, Randomised Controlled Trial’ (IMPACT), we assessed the impact of flash glucose technology on hypoglycaemia compared with capillary glucose monitoring.MethodsThis multicentre, prospective, non-masked, RCT enrolled adults from 23 European diabetes centres. Individuals were eligible to participate if they had well-controlled type 1 diabetes (diagnosed for ≥5 years), HbA1c ≤ 58 mmol/mol [7.5%], were using MDI therapy and on their current insulin regimen for ≥3 months, reported self-monitoring of blood glucose on a regular basis (equivalent to ≥3 times/day) for ≥2 months and were deemed technically capable of using flash glucose technology. Individuals were excluded if they were diagnosed with hypoglycaemia unawareness, had diabetic ketoacidosis or myocardial infarction in the preceding 6 months, had a known allergy to medical-grade adhesives, used continuous glucose monitoring (CGM) within the previous 4 months or were currently using CGM or sensor-augmented pump therapy, were pregnant or planning pregnancy or were receiving steroid therapy for any disorders. Following 2 weeks of blinded (to participants and investigator) sensor wear by all participants, participants with sensor data for more than 50% of the blinded wear period (or ≥650 individual sensor results) were randomly assigned, in a 1:1 ratio by a central interactive web response system (IWRS) using the biased-coin minimisation method, to flash sensor-based glucose monitoring (intervention group) or self-monitoring of capillary blood glucose (control group). The control group had two further 14 day blinded sensor-wear periods at the 3 and 6 month time points. Participants, investigators and staff were not masked to group allocation. The primary outcome was the change in time in hypoglycaemia (<3.9 mmol/l) between baseline and 6 months in the full analysis set.ResultsBetween 4 September 2014 and 12 February 2015, 167 participants using MDI were enrolled. After screening and the baseline phase, participants were randomised to intervention (n = 82) and control groups (n = 81). One woman from each group was excluded owing to pregnancy; the full analysis set included 161 randomised participants. At 6 months, mean time in hypoglycaemia was reduced by 46.0%, from 3.44 h/day to 1.86 h/day in the intervention group (baseline adjusted mean change, −1.65 h/day), and from 3.73 h/day to 3.66 h/day in the control group (baseline adjusted mean change, 0.00 h/day), with a between-group difference of −1.65 (95% CI −2.21, −1.09; p < 0.0001). For participants in the intervention group, the mean ± SD daily sensor scanning frequency was 14.7 ± 10.7 (median 12.3) and the mean number of self-monitored blood glucose tests performed per day reduced from 5.5 ± 2.0 (median 5.4) at baseline to 0.5 ± 1.0 (median 0.1). The baseline frequency of self-monitored blood glucose tests by control participants was maintained (from 5.6 ± 1.9 [median 5.2] to 5.5 ± 2.6 [median 5.1] per day). Treatment satisfaction and perception of hypo/hyperglycaemia were improved compared with control. No device-related hypoglycaemia or safety-related issues were reported. Nine serious adverse events were reported for eight participants (four in each group), none related to the device. Eight adverse events for six of the participants in the intervention group were also reported, which were related to sensor insertion/wear; four of these participants withdrew because of the adverse event.Conclusions/interpretationUse of flash glucose technology in type 1 diabetes controlled with MDI therapy significantly reduced time in hypoglycaemia without deterioration of HbA1c, and improved treatment satisfaction.Trial registration:ClinicalTrials.gov NCT02232698Funding:Abbott Diabetes Care, Witney, UK