Background and Aims

Compared to time below range less is known about the frequency and temporal distribution of hypoglycaemic episodes in CGM data. Pooled analysis of multiple clinical trials from the Hypo-RESOLVE (Hypoglycaemia - REdefining SOLutions for better liVEs) database allows for large-scale exploration of sensor-detected hypoglycaemia (SDH).

Methods

We identified 15 studies (7 in T1D) with short-duration (<40 days) CGM (2165 participants, 45% with T1D). We explored frequency of SDH lasting ≥15 minutes on different levels (<70, <54, <40 mg/dl) by time of day and sensor runtime and glycaemic control by clock time.

Results

While nighttime accounts for 25% of hours in a day (0-6 am), we found 32% of SDH<40, 30% of SDH<54 and 28% of SDH<70 there (figure 1). This pattern was more pronounced in T2D (42, 40, 37%, respectively) than in T1D (30, 27, 24%, respectively). The number of daily SDH episodes <70 mg/dl and <54 mg/dl dropped after the first days and stabilized over sensor runtime while readings <40 mg/dl had less variability (figure 2). The drop was more pronounced in T1D while in T2D the curve over time was flatter for all SHD levels. Analysis by clock time showed tighter glycaemic control for T2D and a surplus of very low readings <40mg/dl for T1D (figure 3).

Conclusions

Further research will aim at explaining the detected patterns in SDH. This will provide people using CGM systems (including people living with diabetes, healthcare professionals as well as researchers and health authorities) with a benchmark of expectable patterns of hypoglycaemia in CGM data.

Background and Aims

Background: Management of type 1 diabetes (T1D) involves consistent glucose monitoring to avoid acute complications. The use of real-time continuous glucose monitors (rtCGM) or intermittently scanning CGM (isCGM) relative to self-monitoring of blood glucose (SMBG) via fingerstick has aided in increasing the number of individuals with T1D reaching glycemic targets. This study aims to compare rtCGM, isCGM, and SMBG groups using real-world data from T1D patients in a large U.S.-based multi-center study.

Methods

Methods: Electronic health record data from the T1D Exchange Quality Improvement (T1DX-QI) Collaborative from 2017-2020 from # sites were analyzed. Patients with complete information on HbA1c, CGM status, and other covariates were included in this analysis. In addition, patients were classified as rtCGM, isCGM, or SMBG users based on their most recent clinic visit data.

Results

Results: This analysis included 21,925 people living with T1D, 2-26 years old, of which 61% were rtCGM users, 5% were isCGM users, and 34% self-monitored blood glucose. Patients in the rtCGM and isCGM group were more likely to be privately insured (73% and 90%) and Non-Hispanic White (73% and 83%) compared to the SMBG group (51% and 69%)[p<0.001 for both]. HbA1c levels and DKA events were lowest in the rtCGM group relative to isCGM and SMBG groups (Median A1c % (IQR): 7.9 (2.1) vs. 8.5(2.2) and 8.7 (2.9); p<0.001, and DKA events (%): 2% vs. 4% and 9%; p<0.001).

Conclusions

Conclusion: This real-world cross-sectional study demonstrates potential benefits of rtCGM relative to isCGM and SMBG in achieving better glycemic outcomes among people with T1D.

Background and Aims

Multiple cross-sectional studies have demonstrated lower use of Continuous Glucose Monitors (CGM) in Non-Hispanic Black (NHB) and Hispanic patients with Type 1 diabetes(T1D). This study is a multicenter trend analysis of ethnic and racial disparities in CGM use

Methods

The T1D Exchange Quality Improvement Collaborative (T1Dx-QI) identified four endocrinology centers from the learning network to pilot an equity-focused Quality Improvement study to address disparities in CGM use amongst NHB and Hispanic compared to Non-Hispanic White (NHW) patients. Retrospective aggregate data from the Electronic Medical Record was reported monthly to the coordinating center. The data were stratified by race and ethnicity. Median values were calculated using Lahey P run charts between Nov 2020 and June 2021. Data were analyzed and plotted on a trend chart

Results

The baseline data from participating clinics show a stable trend (p-value<0.001). The median CGM use was 58% amongst NHW patients, 49% among NHB patients, and 48% among Hispanic patients. The difference in the median between NHW and NHB patients is 9% and the difference between NHW and Hispanic patients is 10%

Conclusions

Baseline analysis of the participating sites in CGM use demonstrates fixed and persistent inequity in CGM use between NHW, NHB, and Hispanic patients. The inequities trend is projected to continue except systemic changes are employed. The T1Dx-QI developed a QI Equity Framework and she is using this with the participating centers to develop and scale interventions that address disparities for Non-Hispanic Black and Hispanic patients with T1D.

Background and Aims

WaveForm has commercialized the Cascade CGM, an electrochemical, trocar-less CGM system for people with diabetes. Accelerating sensor readiness during the initial warm-up phase and up to 48 hours has been recognized as important aspect of improving the performance of the amperometric sensor on day 1. The feasibility of using a specific voltage modulation pattern over the initial warm-up period was assessed in non-diabetic animal model (porcine) and humans.

Methods

Several sensors were inserted in anesthetized Yucatan-mini pigs. During the initial warm-up phase of 60 minutes the bias voltage was modulated. Then after a consistent current was obtained, the system was operated at s steady state bias potential. After about 3 hours the glucose level was elevated by infusion of saline containing 20% dextrose. Blood glucose samples by ear prick were taken every 10 min for a total of 4 hours. The current response of sensors with and without bias modulation was compared. Sensor accuracy was retrospectively assessed. Initial assessment of this approach was performed in a human study.

Results

In animals MARD was significantly improved during the initial 4 hours in sensors being conditioning by bias modulation (11.7%) over sensors treated with steady-bias voltage at 650 mV (19.5%, p<<0.05). Preliminary MARD of 12.5% observed in sensors with bias modulation worn by human subjects over 48 hours confirmed this result.

Conclusions

The feasibility of specific bias modulation during warm-up time of an amperometric sensor was demonstrated. We will report on the results from a currently ongoing clinical trial in humans with diabetes at the meeting.

Background and Aims

To contrast the total and within-day coefficient of variation for glucose (CV) thresholds to guide clinical assessment of glucose variability and hypoglycemic exposure.

Methods

De-identified data provided glucose readings from 1,002,946 flash glucose monitor users. The total and within-day CV and daily scan rate for each reader were found. Readers were grouped by ten equal groups of scan rate, then quartile groups by t-CV and wd-CV were found, for 25,074 readers per group. The association of glucose variability and time below range (TBR) was examined by median time below 54 mg/dL and t-CV and wd-CV.

Results

The association of glucose variability and hypoglycemia was examined as shown in Figure 1. As expected, the wd-CV is always less than the t-CV at any given level of hypoglycemia exposure. Both wd-CV and t-CV were associated with time below 54 mg/dL. In order to achieve the consensus target of < 1% time below 54 mg/dL, the associated wd-CV and t-CV values are 33.5% and 39.5%, respectively.

Conclusions

Health care professionals should be aware of the type of CV reported by the different CGM systems. To our knowledge, the CV calculated in the majority of CGM reports is the t-CV. Then, appropriate thresholds should be used to identify patients likely to meet TBR targets (t-CV < 39.5% or wd-CV <33.5%).

Figure 1: Association of glucose time below 54 mg/dL and glucose variability measured by t-CV and wd-CV. Quartile groups of wd-CV (cross signs) and Total CV (open circles, red=lowest, magenta = highest). N=1,002,946 readers, each point is 25,074 readers.

Background and Aims

Primary Care (PC) performs diabetes management for approximately 50% of adult type 1 diabetes and 90% of type 2 diabetes in the United States, yet CGM uptake is significantly lower in PC than in endocrinology despite known glycemic and quality-of-life benefits. This project aims to increase CGM uptake in Colorado PC practices by developing a novel virtual CGM Initiation Service (virCIS) for PC practices.

Methods

The virCIS project partners with PC practices to identify candidates for CGM, perform CGM onboarding, and support transition of ongoing CGM management to the local PC practice. The program features a one-time, 45-minute CGM overview curriculum for practices, with instruction on how PC practices identify and enlist appropriate patients. virCIS will initiate CGM using a structured protocol implemented by clinical pharmacists, a diabetes care and education specialist, and a nutritionist, all with PC setting expertise. Program duration is three months, with routine updates to the referring practice, and concluding with a virtual “warm handoff” visit between virCIS, the PC practice, and the patient.

Results

Primary outcomes include change in HbA1c and changes in CGM glycemic metrics. Secondary outcomes include changes in BMI, diabetes distress, practice satisfaction, and patient satisfaction. Economic analysis will also be conducted, and a toolkit will be developed to empower other PC settings to develop their own CGM initiation services.

Conclusions

We anticipate that virCIS will increase PC practices’ abilities to initiate and maintain CGM use while also improving glycemia, patient satisfaction, and practice satisfaction.

Background and Aims

Primary care performs diabetes management for approximately 50% of adult patients with type 1 diabetes and 90% of those with type 2 diabetes in the United States, yet CGM uptake is significantly lower in primary care than in endocrinology despite known glycemic and quality-of-life benefits. This project aims to increase CGM uptake in primary care practices in Colorado, with a randomized trial comparing two CGM implementation strategies. The investigators, in conjunction with the American Academy of Family Physicians (AAFP), developed a Transformation in Practice Series (TIPS^TM) CGM implementation package for primary care practices. Practice facilitation is a strategy shown to enhance implementation efforts. This study will compare CGM implementation using AAFP TIPS^TM CGM with and without additional practice facilitation to assist in implementation.

Methods

40 Colorado primary care practices will agree to use the AAFP TIPS^TM CGM package to implement CGM and will be randomized to receive (a) no additional support resources or (b) six professional practice facilitation sessions for CGM implementation.

Results

Primary outcome: CGM prescriptions initiated. Secondary outcomes: changes in HbA1c, CGM glycemic metrics, diabetes distress, practice satisfaction, and patient satisfaction. Economic analysis will also be conducted.

Conclusions

We anticipate that AAFP TIPS^TM CGM implementation will increase primary care practice CGM initiation, with practice facilitation adding incremental benefit. Relative costs vs. revenue will be determined and compared for the two groups.

Background and Aims

Night shift-work is an example of severe circadian misalignment and is associated with increased risk of developing diabetes. In patients with established diabetes, shift-work may be associated with poor glycemic control, but the data are scarce. Our aim was to evaluate if among patients with type 1 diabetes (T1D) under continuous subcutaneous insulin infusion therapy (CSII), glycemic control is worse in night shift-workers (NSW) compared to daily-workers (DW).

Methods

Retrospective analysis of T1D patients under CSII followed at our department: 28 NSW and 28 randomly selected age and sex-matched controls (DW). We collected data from CGM from the last 90 days: time in range (TIR; 70-180 mg/dL), time above range (TAR), time below range (TBR), and glycemic variability (%CV). Patients treated with CSII plus SGLT2-I were not excluded.

Results

The groups were similar with respect to duration of diabetes, age and HbA1c before starting CSII, and treatment with SGLT2-I. A significantly lower TIR (53.5% (43.0-63.0) vs 65.5% (60.3-71.8), p<0.001), higher TAR (39.0% (32.0-50.5) vs 27.5% (20.0-34.0), p=0.002), and higher %CV (42.9% (37.6-47.5) vs 39.0% (35.9-41.3), p=0.003) was observed in the NSW group (with no differences in TBR). Multivariate regression analysis showed that these results were independent of age, duration of diabetes, HbA1c before CSII, healthcare occupation and SGLT2-I treatment (p<0.05).

Conclusions

Night shift-workers had significantly poorer glycemic control compared to daily-workers. Even with CSII therapy, alterations in dietary intake and sleep with circadian misalignment may represent a challenge to optimum control in this group of patients.

Background and Aims

Insulin pump (CSII), continuous glucose monitoring (CGM) and sensor augmented pump (SAP) technology has evolved continuously over the last years. Aim of this study was to assess changes in use of these technologies over time and to identify potential issues regarding technology usage.

Methods

A large patient registry (Diabetes Prospective Follow-up Database, DPV) from Germany, Austria, Switzerland, and Luxembourg was used. The use of CSII, CGM, AID (automated insulin delivery) and SAP between 01/2018 and 06/2021 with T1D was analyzed depending on age, sex and region of care (see Table).

Results

43,835 patients with T1D treated in 416 diabetes centres between 2018 and 2021 met the inclusion criteria.

In group C, 56% of female patients used CSII and 36% SAP, whereas 47% of male patients used CSII and 29% SAP (both p<0.001).In group D, 53% female patients used CSII, 31% SAP and 69% CGM. Whereas 41% of the male patients used CSII, 23% SAP and 65% CGM (all p<0.001).There was a significant difference in the use of CSII, CGM and AID between the old and new federal states of Germany (CSII 55% versus 52%, CGM 76% versus 71%, AID 12% versus 8%; (all p<0.001)).

Conclusions

There has been an increase in the overall use of SAP and AID with the highest use in the younger age groups. A significant difference in the use of SAP between female and male patients could be demonstrated during puberty and in young adults. The new technologies are used more often in the old federal states of Germany.

Background and Aims

Studies in rodents demonstrate that increases in circulating pituitary-derived alpha-melanocyte stimulatory hormone (α-MSH) contribute to post-prandial glycaemic control. Moreover, intravenous administration of exogenous α-MSH lowers glucose excursions during oral glucose tolerance testing (OGTT) in mice. We set out to interrogate whether this action translated to human physiology both in vivo and in vitro

Methods

Using a randomized double-blinded cross-over design, fifteen healthy volunteers received infusions of physiological saline, 15, 150 and 1500 ng/kg/hr α-MSH initiated 30 minutes prior to the administration of a standard OGTT. Plasma glucose and insulin was measured during the OGTT. To assess the effect of α-MSH on glucose disposal into skeletal muscle disposal, 15 subjects underwent sequential hyperinsulinaemic-euglycaemic clamp, concomitant to either saline or 150ng/kg/hr α-MSH infusion. In a separate cohort of healthy volunteers (n=6), vastus lateralis muscle biopsies were obtained and used to establish cultures of primary human myotubes. Tritiated 2-deoxy-D-glucose was used to monitor glucose uptake in response to α-MSH.

Results

Infusion of α-MSH (1500ng/kg/hr) reduced the incremental area under the curve (iAUC) for plasma glucose (p=0.02), and plasma insulin (p=0.006) by approximately 20%. At high steady state insulin concentrations in clamp studies, α-MSH increased glucose requirements for the maintenance of euglycaemia. Primary human myotube cultures expressed melanocortin receptor subtypes (MC1R>MC3R≈MC4R) and both 10nM and 100nM α-MSH increased glucose uptake by two-fold versus vehicle (p=0.001).

Conclusions

These findings substantiate a role for peripheral α-MSH as a hitherto undescribed component of the endocrine control of glycaemia in human physiology.