Background and Aims

This study investigated safety and effectiveness outcomes after HCL versus CSII use for six months.

Methods

Participants (n=302, aged 2-80 years) with T1D were randomized to MiniMed™ 670G system HCL or control (CSII without CGM) for six months, after completing a baseline run-in period (~2 weeks). Effectiveness endpoints included difference in A1C, time spent below target range (TBR<70mg/dL), time spent in target range (TIR, 70-180mg/dL) over 24 hours and nighttime, and coefficient of variation (CV). Endpoints were evaluated by baseline HbA1c >8% (Group 1) and baseline HbA1c ≤8% (Group 2) first, then by combined groups (Group 1 and 2). A one-way ANOVA was used to compare HCL and CSII outcomes. Safety endpoints included severe hypoglycemic, diabetic ketoacidosis (DKA) and serious device-related adverse events (AEs).

Results

For each group, HbA1c and TBR<70mg/dL were lower with HCL versus CSII (p<0.001 for both, Table). For the overall group, the nighttime and 24-hour TIR, in addition to CV, were also improved with HCL (p<0.001 for all). Throughout the study period, there was 1 serious device-related AE (HCL), 4 severe hypoglycemic (HCL:0, Control:4) events, and no DKA events.

Conclusions

This large RCT demonstrated significant improvement in glycemic control with HCL therapy over CSII therapy irrespective of baseline HbA1c.This large RCT demonstrated significant improvement in glycemic control with HCL therapy over CSII therapy irrespective of baseline HbA1c.

Background and Aims

Insulin therapy should be individualized for users’ unique treatment goals. The Omnipod 5 System provides automated insulin delivery (AID) with customizable glucose targets from 110-150mg/dL (6.1-8.3mmol/L). This analysis assessed system performance at specific glucose targets during the 3-month pivotal study in very young children (aged 2-5.9y) with type 1 diabetes (T1D).

Methods

Participants with A1C<10% (86mmol/mol) used the AID system for 3 months at home after a 14-day standard therapy (ST) phase. Glucose targets from 110-150mg/dL (6.1-8.3mmol/L) in 10mg/dL (0.55mmol/L) increments were programmable by time of day. Primary safety and efficacy endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and sensor glucose percent time in target range (TIR) (70-180mg/dL, 3.9-10.0mmol/L) during AID at each glucose target compared with ST.

Results

Participants (N=80), aged (mean±SD) 4.7±1.0y with T1D duration 2.3±1.1y, had a total daily dose (TDD) of 13.7±4.4units (range 5.3-27.1units) and baseline A1C of 7.4±1.0% (57±10.9mmol/mol) (range 5.4-10.2%, 36-88mmol/mol). TIR improved during the AID phase with all targets, while time <70mg/dL (<3.9mmol/L) remained low at the 110mg/dL (6.1mmol/L) target and decreased with all other targets (Table). There was no correlation between time-weighted average target and age (r=-0.02) or TDD (r=0.05), (both p>0.05). There were no SH or DKA episodes.

Conclusions

The Omnipod 5 System was safely used by a large cohort of very young children with T1D at glucose targets from 110-150mg/dL (6.1-8.3mmol/L). The 110mg/dL (6.1mmol/L) and 120mg/dL (6.7mmol/L) targets were used most often, at a combined 75% of the time.

Background and Aims

Older adults with type 1 diabetes (T1D) have distinct characteristics that can make optimising glycaemic control challenging. We hypothesised that hybrid closed-loop is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with T1D.

Methods

In a multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and over with T1D using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX) and SAP therapy in random order. The primary endpoint was the proportion of time sensor glucose was in target range between 3.9 and 10.0mmol/L. ClinicalTrials.gov NCT04025762.

Results

Thirty-seven participants (mean±SD age 67±5 years, baseline HbA1c 7.4±0.9% [57±10mmol/mol]) were randomised between 4 September 2019 and 2 October 2020. The proportion of time glucose was between 3.9 and 10.0mmol/L was 8.6 percentage points (95% CI 6.2 to 11.0) higher during closed-loop compared to SAP (p<0.001). Time with glucose >10.0mmol/L was 8.4 percentage points lower (95% CI -11.0 to -6.0; p<0.001), mean glucose was 0.7mmol/L lower (95% CI -0.9 to -0.5; p<0.001), and glycated haemoglobin was 0.2% lower (95% CI -0.4 to -0.1; p<0.001) with closed-loop than with SAP. Time in hypoglycaemia (<3.9mmol/L) was similar between periods (p=0.54). Two severe hypoglycaemia events occurred during the SAP period. There were no other treatment related serious adverse events.

Conclusions

Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control than SAP therapy without increasing the risk of hypoglycaemia in older adults with T1D.

Funding: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Background and Aims

The aim of this study was to compare the efficacy of the currently available Advanced Hybrid Closed Loop (AHCL) technologies, Tandem Control-IQ and Minimed780G, on glycemic control in pediatric and adult patients with Type 1 Diabetes (T1D).

Methods

Continuous glucose monitoring (CGM) data from 90 patients, who upgraded to Minimed780G or Tandem Control-IQsystem and have completed 1-month observation period, were retrospectively analyzed. The two groups were matched and reduced to 32 patients each to minimize the imbalances among basic characteristics. Additionally, an adjustment for baseline HbA1c levels was required.

Results

All 64 matched patients showed a statistically significant improvement of time in range (TIR) (+9.1%, p= 0.001), time above range (TAR) > 250 mg/dl (-9.9%, P=<0.001), standard deviation (SD) (-12.8%, P =0.001) and average glycemia (-22.8%, P=<0.001). Tandem Control-IQ system significantly reduced the frequency of hypoglycemia 70-54 mg/dl, while Minimed 780G increased it (-0.77% vs +0.44% p=0.018).

Conclusions

The use of ACHL systems led to a significant improvement of glycemic control. Minimed 780G appears to be more effective in managing hyperglycemia, while Tandem Control-IQ seems to be more effective in reducing time in hypoglycemia. Understanding the strengths and weaknesses of these devices could be useful to define a customized insulin therapy.

Background and Aims

Glycemic control is challenging due to the complex blood glucose (BGL) regulation dynamics. A system generating personalized models to mimic the individual BGL regulation physiology was developed, enabling BGL predictions up to 24 hours and personalized insulin dose optimization.

Methods

96 subjects (30 T1DM and 66 T2DM, 53 female, age 47.9±15.5 years, BMI of 29.1±5.0 kg/m2) included in a clinical study carried out in partnership with Grupo Fleury and Medtronic were monitored during 144 hours with CGM (required 2 or more calibrations/day), activity tracker and our own mobile app to collect BGL, meal, insulin and physical activity data. The model was individually trained using 96-hour data, and tested using 24-hour data by calculating 6-hour and 24-hour BGL prediction curves that were evaluated using MARD and Consensus Error Grid (CEG).

Results

The median MARD for all, T1DM and T2DM patients for 6-hour BGL predictions was 16.0%, 29.8% and 13.9% respectively, and for 24-hour was 16.8%, 37.1% and 14.5% respectively. The median CEG points in zones AB (CEG_AB) for 6-hour and 24-hour BGL predictions for all and T2DM patients was 100%, while T1DM patients showed 91.6% and 89.7% respectively. The median CEG points in zones DE (CEG_DE) was 0% for all groups and prediction horizons.

Conclusions

Our model accurately predicted BGL up to 24-hour ahead, showing potential on BGL excursion risk identification, insulin dose optimization, preventive actions recommendation, among others. We thank Grupo Fleury for clinical, financial, protocol design, structure, and follow-up support, and Medtronic for providing the iPro2 CGMs and protocol design support.

Background and Aims

Only two studies have compared the efficacy of dual-hormone (DH) automated insulin delivery (AID) systems, single-hormone (SH) AID and usual care (UC) on post-exercise overnight glucose management in people living with type 1 diabetes (PWT1D); their conclusions differ. By pooling data from these two studies, we aim to draw stronger conclusions.

Methods

Data were pooled from two open-label, randomized, controlled, crossover studies. Forty-one adults PWT1D [median (Q1-Q3) age: 34.0 years (29.5, 51.0), mean ± SD hbA1c: 7.5 ± 0.2%] and 17 adolescents PWT1D [age: 14.0 (13.0, 16.0), hbA1c: 7.8 ± 0.2%] underwent DH-AID, SH-AID and UC (pump+capillary blood glucose). Each intervention contained an evening, 60-minute, moderate aerobic exercise session. The primary outcome was time in range% (TIR%) overnight (00:00-06:00) post-exercise based on continuous glucose monitoring. The three groups were compared using linear mixed effect model or generalized linear mixed model.

Results

Among adults, TIR% (mean ± SD) was 94.0% ± 11.9%, 83.1% ± 20.5% and 65.1% ± 37.0% during DH-AID, SH-AID and UC intervention, respectively (P<0.05 for all between-group comparisons) (Table 1). DH-AID was superior to SH-AID and UC, and SH-AID was superior to UC regarding hypo- and hyperglycemia prevention but not glycemic variability. Among adolescents, DH-AID and SH-AID were both superior to UC regarding hypo- and hyperglycemia prevention but not glycemic variability (Table 2). Glycemic outcomes were similar between DH-AID and SH-AID (P>0.05).

Conclusions

Regarding post-exercise nocturnal glucose management, AIDs were both better than UC for both adult and adolescent PWT1D; DH-AID was better than SH-AID among adult but not adolescent PWT1D.

Background and Aims

The use of DIYAPS is increasing with several thousand of users worldwide. Given their unapproved and unlicensed status, objective glycaemic and safety data is needed. The ABCD DIYAPS audit programme was launched in 2020 with the aim of providing clinically validated data. We present our most up-to-date data from the audit.

Methods

Data were extracted from the ABCD DIYAPS audit tool. Those with baseline and available follow-up data were included. Main outcomes of interest were related to glucose control (e.g. HbA1c, time-in-range) and safety (e.g. adverse events, hospital admissions) outcomes. Analyses were performed using Stata 16.

Results

Data were included for 101 individuals, 55% male, mean±SD baseline HbA1c 54±16 mmol/mol and weight 84.1±26.0kg, median diabetes duration 25.5 years (IQR 17.0-33.5). After mean±SD follow-up of 1.6±1.1years HbA1c decreased significantly by -6.4mmol/mol (95% CI -3.4--9.5, p<0.001). Mean time-in-range (3.9-10mmol/L) at follow-up was 79% (SD ±11.5) and time-below-range 3.1% (SD ±2.2). Two adverse events related to DIYAPS use were reported – insulin over-delivery due to third-party app interference. One user continued to experience severe hypoglycaemia. Three admissions were noted (2 hypoglycaemia, 1 hyperglycaemia) but there was no significant change in the number of hospital admissions (baseline 7 events) or paramedic callouts following DIYAPS commencement (no events at baseline or follow-up).

Conclusions

Our data suggest that DIYAPS use is associated with clinically significant improvements in HbA1c, with most achieving optimal time-in-range and time-below-range. Ongoing vigilance for adverse events will be needed and comparison with commercially available alternatives will be vital moving forwards.

Background and Aims

Background: Existing therapeutic interventions to treat diabetes are well known, yet the majority of people with diabetes do not consistently achieve blood glucose targets (even individual therapy targets) for optimal health, despite the large range of treatment options available. Such outcomes have remained stubbornly poor for decades with <25% adults with diabetes achieving glycaemic targets. The medical healthcare model is not ideally suited to supporting effective diabetes management. In routine clinical care, patient-identified priority concerns may be missed by the care team.

Aim: To determine clinical and cost effectiveness of the Spotlight-AQ Pre-clinic assessment and mapped care planning intervention in a multi-centre RCT

Methods

Participants: Adults with type 1, type 2 or pre-diabetes attending routine care outpatient appointments.

Design: Multi-centre, parallel group, individually randomised trial comparing consultation duration in adults with type 1, type 2 or pre-diabetes using the Spotlight Consultations pre-clinic assessment compared to usual care in the Spotlight-AQ study.

Intervention: An outpatient pre-clinic intervention delivered within one week prior to scheduled routine outpatient appointment.

Sample size: 200 recruited

Results

Primary outcome measure: Duration of routine outpatient consultation.

Secondary outcome measures:

Functional health status

Diabetes distress

Depression

Treatment satisfaction

Impact on self-care behaviours

HCP burnout

HCP treatment satisfaction and burden

Hypoglycaemia (time less than 70mg/dL)

Hyperglycaemia (time above 180 mg/dL)

Change in weight

Change in HbA_1c

Cost effectiveness of intervention

Trial Registration: ISRCTN15511689

Conclusions

Preliminary results will be presented with implications for routine care delivery in terms of reducing healthcare professional burnout whilst improving physical and mental health outcomes for people with diabetes

Background and Aims

Despite clinical benefits and regulatory approval in Europe, there is reluctance to sodium-glucose cotransporter inhibitor (SGLTi) use in type 1 diabetes (T1D), due to increased risk of developing diabetic ketoacidosis (DKA). Not much is known about the possible risks or benefits when combining SGLTi with hybrid closed-loop (HCL) systems.

Methods

Detailed description of changes in daily insulin dosing by a Medtronic MiniMed^TM 780G algorithm in a 23-year-old woman with T1D after SGLTi initiation leading to DKA.

Results

Within a few days after start of SGLTi, the HCL control algorithm reduced the autobasal and autocorrection doses (panel A and B in Figure). Meal bolus insulin doses were already reduced in the week prior to initiation of SGLTi (panel C), as a result of a lower carbohydrate intake by our patient (panel D). After start of SGLTi, meal bolus insulin doses remained at a lower level, not only due to lower carbohydrate intake, but also due to frequent activation of the ‘safe meal bolus’ (* in panel C). Taken together, there was a significant 49% reduction in total daily insulin dose in the 2 weeks after start of SGLTi, leading to development of DKA due to insulin doses below the minimum needed to prevent ketone formation.

Conclusions

We recommend caution with SGLTi use in people with T1D and concomitant Medtronic MiniMed^TM 780G use, until more is known about the influence of SGLTi on HCL control algorithm functioning, in order to avoid an even greater risk of DKA.

Background and Aims

How do physicians assess AID-Systems in terms of their current and future importance for diabetes care?

Methods

In 2021 305 diabetologists in Germany (48% female, average age 53.7 years) were asked via online surveys about their current and future assessment of AID-Systems.The results were compared with the 2019 survey, in which 337 diabetologists (43% female, mean age 53.2 years) participated.

Results

Currently, 58.6% (2020: 51.4%) of diabetologists consider AID-Systems to be important for diabetes care, in 5 years 89.3% (2020: 86.4%). Diabetologists estimate that in approx. 9 years one in two PwD TD1 in Germany will be a user of an AID-System, and in approx. 17 years 90% will use an AID-System. Currently, they estimate that 57.6% of all PwD-TD1 are suitable for an AID-System. Diabetologists see the clearest impact of AID-Systems in an increased need for diabetes selfmangement education (78.9%), but also in PwD becoming much more autonomous and empowered (62.8%). Regarding possible negative effects of AID-Systems, diabetologists see only few risks: 20% fear that PWD will have less contact with the diabetes team, 16.9% are concerned that PWD will not be able to cope with the technological change. Only 7.9% fear that PWD will become riskier with AID-Systems, only 1.7% have fears that the diabetes team will become superfluous.

Conclusions

Overall, diabetologists assess AID-Systems as a important innovation for diabetes care and that this will soon become the standard therapy for T1D. The effort for Diabetes self-management education and support is estimated to be relatively high, possible disadvantages relatively low.