Use Of rtCGM Research Articles

Time In Range in Children with Type 1 Diabetes Using Treatment Strategies Based on Nonautomated Insulin Delivery Systems in the Real World.

Background: Glucose sensors consist of real-time continuous glucose monitoring (rtCGM) and intermittently scanned CGM (isCGM). Their clinical use has been widely increasing during the past 5 years. The aim of this study is to evaluate percentage of time in range (TIR) in a large group of children with type 1 diabetes (T1D) using glucose sensors with nonautomated insulin delivery systems, in a real-world setting. Methods: An 11-center cross-sectional study was conducted during January-May 2019. Children with T1D <18 years, all using rtCGM or isCGM for >1 year, treated with multiple daily injections (MDI) or nonautomated insulin pump (IP), were recruited consecutively. Clinical data, HbA1c measurement, and CGM downloaded data were collected by each center and included in a centralized database for the analysis. Glucose metrics of four treatment strategies were analyzed: isCGM-MDI, rtCGM-MDI, isCGM-IP, and rtCGM-IP. Results: Data from 666 children with T1D (51% male and 49% female), median age 12 years, diabetes duration 5 years, were analyzed. An rtCGM was used by 51% of the participants, and a nonautomated IP by 46%. For isCGM-MDI, rtCGM-MDI, isCGM-IP, and rtCGM-IP, the median TIR 70-180 mg/dL values were 49%, 56%, 56%, and 61% (P < 0.001), respectively; HbA1c 7.6%, 7.5%, 7.3%, and 7.3% (P < 0.001), respectively. Use of rtCGM was associated with significant lower time below target range <70 mg/dL and reduced the percentage coefficient of variation of glucose (%CV), independently by the insulin delivery system used. Conclusions: Among nonautomated insulin delivery strategies, simultaneous use of rtCGM and IP was associated with higher percentage of TIR, lower time above range >180 mg/dL and lower HbA1c. If there are no barriers, an upgrade of the treatment strategy with a higher performing technology should be offered to all children who do not achieve blood glucose metrics within the suggested range.

Continuous Glucose Monitoring in People With Type 1 Diabetes on Multiple-Dose Injection Therapy: The Relationship Between Glycemic Control and Hypoglycemia

The inverse relationship between overall glucose control and hypoglycemia risk is weakened by the use of real-time continuous glucose monitoring (rtCGM). We assess the relationship between glucose control and hypoglycemia in people with type 1 diabetes using multiple-dose injection (MDI) regimens, including those at highest risk of hypoglycemia. CGM data from the intervention (rtCGM) and control (self-monitored blood glucose [SMBG]) phases of the Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIAMOND) and HypoDE studies were analyzed. The relationship between glucose control (HbA1c and mean rtCGM glucose levels) and percentage time spent in hypoglycemia was explored for thresholds of 3.9 mmol/L (70 mg/dL) and 3.0 mmol/L (54 mg/dL), and ANOVA across the range of HbA1c and mean glucose was performed. A nonlinear relationship between mean glucose and hypoglycemia was identified at baseline, with the steepest relationship seen at lower values of mean glucose. The use of rtCGM reduces the exposure to hypoglycemia at all thresholds and flattens the relationship between overall glucose and hypoglycemia, with the most marked impact at lower values of mean glucose and HbA1c. Exposure to hypoglycemia varied at all thresholds across the range of overall glucose at baseline, in the SMBG group, and with rtCGM, but the relationships were weaker in the rtCGM group. Use of rtCGM can flatten and attenuate the relationship between overall glucose control and hypoglycemia, exerting its greatest impact at lower values of HbA1c and mean glucose in people with type 1 diabetes using MDI regimens and at highest risk of hypoglycemia.

Carbohydrate Loading Followed by High Carbohydrate Intake During Prolonged Physical Exercise and Its Impact on Glucose Control in Individuals With Diabetes Type 1-An Exploratory Study.

Background: Prolonged physical exercise (PE) is a challenge in type 1 diabetes with an increased incidence of both hypoglycemia and hyperglycemia.Purpose: To evaluate the impact of two consecutive days of carbohydrate (CHO) loading, followed by high intermittent CHO-intake during prolonged PE, facilitated by a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM), on glucose control in individuals with type 1 diabetes.Methods: Ten physically active individuals with type 1 diabetes were invited to participate in a 3-day long sports camp with the objective to evaluate CHO-loading and high intermittent CHO-intake during prolonged PE. 1.5 months later the same procedure was evaluated in relation to a 90 km cross-country skiing race (Vasaloppet). Participants were instructed to act proactively using rtCGM with predictive alerts to maintain sensor glucose values within target range, defined as 72–180 mg/dl (4–10 mmol/l).Results: Mean glucose values during CHO-loading were: day 1; 140.4 ± 45.0 mg/dl (7.8 ± 2.5 mmol/l) and day 2; 120.6 ± 41.4 mg/dl (6.7 ± 2.3 mmol/l). Mean sensor glucose at start of PE was 126.0 ± 25.2 mg/dl (7.0 ± 1.4 mmol/l) and throughout PE 127.8 ± 25.2 mg/dl (7.1 ± 1.4 mmol/l). Percentage of time spent in range (TIR) respective time spent in hypoglycemia was: CHO-loading 74.7/10.4% and during PE 94.3/0.6%.Conclusions: High intermittent CHO-intake during prolonged PE combined with proactive use of rtCGM is associated with good glycemic control during prolonged exercise in individuals with diabetes type 1. However, the time spent in hypoglycemia during the 2-days of CHO-loading was 10.4% and therefore a lower insulin dose might be suggested to reduce the time spent in hypoglycemia.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03722225

279-OR: How to Use rtCGM Data to Predict Future Severe Hypoglycemia?

We combined rtCGM-baseline-data of the HypoDE and DIAMOND study to predict future severe hypoglycemia (SH; third party assistance for recovery). At baseline, in both studies, the rtCGM system (Dexcom G4) was masked. We analyzed the data of 127 study participants in the control groups with type 1 diabetes (age 46.0 ±11.5 years; diabetes duration 22.4 ±14.1 years, A1c 7.9 ±1.0%) using SMBG during the trials. According to the consensus statement we used the following hypoglycemia-specific predictors: % of glucose values &amp;lt; 70mg/dl and &amp;lt;54 mg/dl, the number of such events, Low Blood Glucose Index (LBGI), and the coefficient of variation (CV). After baseline, a total of 44 severe hypoglycemic events were observed during the following 6-months; with 12.6% affected participants. We analyzed the area under the Receiver Operating Characteristics (ROC) curves and determined cut-off values with an optimal sensitivity and specificity (Table). All hypoglycemia-related parameters, except CV, were able to predict SH during the next 6 months significantly better than prediction by chance; e.g., if ≥ 7% of glucose values were &amp;lt; 70 mg/dl, the probability for SH in the next 6-months was 23.4%. CGM-derived hypoglycemic outcome parameters might help to identify people with diabetes who have an increased risk for future hypoglycemia. These results should be corroborated by non-masked use of rtCGM but might also be useful in patients using SMBG. Disclosure N. Hermanns: Advisory Panel; Self; Abbott. Board Member; Self; Eli Lilly and Company. Research Support; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc., Roche Diabetes Care. Speaker's Bureau; Self; Berlin-Chemie AG, Dexcom, Inc., Novo Nordisk A/S. D. Ehrmann: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. G. Freckmann: Advisory Panel; Self; Abbott, Novo Nordisk Pharma GmbH, Sensile Medical AG. Consultant; Self; Metronom Health Europe, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; Ascensia Diabetes Care, Dexcom, Inc., Ypsomed AG. L. Heinemann: Consultant; Self; Roche Diabetes Care. Research Support; Self; Dexcom, Inc. Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Funding Dexcom, Inc.

RtCGM Usage Is Associated with a Significant Reduction of Time Spent in Hypoglycemia in Patients with Type 1 Diabetes Treated with Multiple Daily Injections—Results of the HypoDE Study

In this randomized multi-center study, performed in 12 specialized diabetes practices in Germany, we examined the impact of rtCGM use (Dexcom G5) on the duration of time spent in hypoglycemia. In total, 149 MDI-treated patients with type 1 diabetes and hypoglycemia problems (age 47±20 years, HbA1c 7.5±1.0%, 60.4% with at least one recent severe hypoglycemic event, unawareness score 4.9±1.2) used a masked rtCGM system for 4 weeks. After this baseline phase, 75 patients were randomized to rtCGM use and 74 were randomized to the control group with continuation of SMBG for the next 26 weeks. From week 22 till 26 after randomization, the control group had a masked rtCGM system again. The CGM group continued their use of rtCGM. Six-month follow-up data could be obtained from 141 participants. In the CGM group, the duration of time per day spent ≤70 mg/dl was lower compared to the Control group (42.6 vs. 112.0 min/day; adjusted Δ 69.4 min/day, 95% CI 52.4 to 86.4 min/day, p&amp;lt;0.0001). The time per day spent in &amp;lt;55 mg/dl showed the same pattern (11.2 vs. 53.2 min/day; adjusted Δ 41.9 min/day, 95% CI 31.4 to 52.2 min/day, p&amp;lt;0.0001). Time in range per day was longer in the CGM group than in the Control group (850.5 vs. 805.6 min/day; adjusted Δ 44.9 min/day, 95% CI -0.3 to 90.0 min/day, p=0.051). Time per day spent in hyperglycemia (&amp;gt;180 mg/dl) was slightly higher in the CGM group than in the Control group (544.2 vs. 525.5 min/day; adjusted Δ -18.7 min/day, 95% CI -70.3 to 32.9 min/day, p=0.474). HbA1c at follow-up was comparable between CGM and Control group (7.3% vs. 7.3%; adjusted Δ 0.0%, 95% CI -0.1 to 0.2%, p=0.665). The use of rtCGM in MDI-treated type 1 diabetic patients with hypoglycemia problems can significantly reduce exposure to hypoglycemic glucose values without compromising glycemic control. Given the rather higher costs of CSII treatment compared to MDI, these results are of high clinical as well as health-economic relevance. Disclosure L. Heinemann: Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Consultant; Self; Roche Diabetes Care Health and Digital Solutions. G. Freckmann: Speaker's Bureau; Self; Ascensia Diabetes Care. Research Support; Self; Ascensia Diabetes Care. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Abbott, Novo Nordisk Inc.. Consultant; Self; Sensile Medical AG. Speaker's Bureau; Self; Ypsomed AG. D. Waldenmaier: None. D. Ehrmann: Speaker's Bureau; Self; Berlin-Chemie AG. N. Hermanns: Speaker's Bureau; Self; Berlin-Chemie AG. Advisory Panel; Self; Abbott. Research Support; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Berlin-Chemie AG. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Ypsomed AG, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk Inc..

Predictors of Hypoglycemia Avoidance in a Randomized Controlled rtCGM Trial (HypoDE)

The HypoDE study, a randomized multi-center trial, showed that rtCGM use reduces the number of low glucose events (&amp;lt;55 mg/dl for at least 20 minutes) per 28 days from 10.4 to 3.4 events compared to SMBG (13.5 to 13.2 events) in MDI-treated type 1 diabetic patients with hypoglycemia problems. In this post-hoc analysis, we analyzed which baseline variables predict successful reduction of low glucose events. The criterion was a reduction to 0 events or by 50% from baseline. In a block-wise, multivariate logistic regression, demographic and medical variables, patient-reported-outcomes, biochemical hypoglycemia at baseline (based on 4-week masked rtCGM use), hours per day in time in range and hyperglycemia, and use of rtCGM were used as predictors. Model fit of the block-wise regression suggests that none of the baseline characteristics did predict hypoglycemia avoidance. However, entering use of rtCGM led to a rise of Nagelkerke´s R² from 0.061 to 0.331. This indicates that rtCGM use was the most important predictor for hypoglycemia avoidance. In the CGM Group, 76.1% of the patients compared to 26.3% in the Control group could avoid hypoglycemic events (Odds ratio 9.8, 95% CI 4.2 to 23.0). This suggests that rtCGM use is effective in patients with type 1 diabetes and hypoglycemia problems regardless of diabetes duration, glycemic control, severity of hypoglycemia problems, and exposure to biochemical hypoglycemia at baseline. Predictors of hypoglycemia avoidanceCharacteristicsNagelkerke´s R²Delta - Nagelkerke´s R²Block 1Demographic variables (age, diabetes Duration)0.005Block 2Block 1 + medical variables (HbA1c, severe hypoglycemia in the past 12 month, hypoglycemia unawareness0.0220.017Block 3Block 2 + Patient reported outcomes (fear of hypoglycemia, diabetes distress, satisfaction with glucose monitoring, self-reported health status)0.0290.027Block 4Block 3 + biochemical hypoglycemia at baseline (time spent ≤70 and ≤55 mg/dl per day, baseline low glucose Events)0.0580.009Block51Block 4 + time in range and time in hyperglycemia (&amp;gt;180 mg/dl)0.0610.003Block 6Block 5 + Treatment (rtCGM vs. SMBG)0.3310.270 Disclosure N. Hermanns: Speaker's Bureau; Self; Berlin-Chemie AG. Advisory Panel; Self; Abbott. Research Support; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Berlin-Chemie AG. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Ypsomed AG, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk Inc. L. Heinemann: Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Consultant; Self; Roche Diabetes Care Health and Digital Solutions. G. Freckmann: Speaker's Bureau; Self; Ascensia Diabetes Care. Research Support; Self; Ascensia Diabetes Care. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Abbott, Novo Nordisk Inc.. Consultant; Self; Sensile Medical AG. Speaker's Bureau; Self; Ypsomed AG. D. Waldenmaier: None. D. Ehrmann: Speaker's Bureau; Self; Berlin-Chemie AG.

Health Care Costs, Hospital Admissions, and Glycemic Control Using a Standalone, Real-Time, Continuous Glucose Monitoring System in Commercially Insured Patients With Type 1 Diabetes.

Background:Studies comparing standalone real-time continuous glucose monitoring (rtCGM) to self-monitoring of blood glucose (SMBG) in patients with type 1 diabetes mellitus (T1DM) have found that rtCGM is associated with lower glycated hemoglobin (A1C) levels, yet does not increase the risk of severe hypoglycemia. However, little is known about the relationship between rtCGM and health care costs and utilization. The objective of this study was to compare health care spending, hospital admissions, and A1C levels of patients using rtCGM to that of patients not using rtCGM.Methods:This retrospective, cross-sectional analysis used a large repository of health plan administrative data to compare average health care costs (excluding durable medical equipment), hospital admissions, and A1C levels of those using rtCGM (N = 1027) versus not using rtCGM (N = 32 583). To control for potentially confounding variables, a propensity score method was used to match patients using rtCGM to those not using rtCGM, based on characteristics such as age, gender, and comorbidities.Results:Patients using rtCGM spent an average of approximately $4200 less in total health care costs, when compared to patients not using rtCGM (P < .05). They also experienced fewer hospital admissions (P < .05) and lower A1C (P < .05) during the postindex year.Conclusions:Use of rtCGM by patients with T1DM is associated with lower health care costs, fewer hospital admissions, and better glycemic control.

Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial

The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals. The HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial done at 12 diabetes practices in Germany. Eligible participants had type 1 diabetes and a history of impaired hypoglycaemia awareness or severe hypoglycaemia during the previous year. All participants wore a masked rtCGM system for 28 days and were then randomly assigned to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the control group (continuing with self-monitoring of blood glucose). Block randomisation with 1:1 allocation was done centrally, with the study site as the stratifying variable. Masking of participants and study sites was not possible. Control participants wore a masked rtCGM system during the follow-up phase (weeks 22-26). The primary outcome was the baseline-adjusted number of hypoglycaemic events (defined as glucose ≤3·0 mmol/L for ≥20 min) during the follow-up phase. The full dataset analysis comprised participants who wore the rtCGM system during the baseline and follow-up phases. The intention-to-treat analysis comprised all randomised participants. This trial is registered with ClinicalTrials.gov, number NCT02671968. Between March 4, 2016, and Jan 12, 2017, 149 participants were randomly assigned (n=74 to the control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 in the control group, n=75 in the rtCGM group). The mean number of hypoglycaemic events per 28 days among participants in the rtCGM group was reduced from 10·8 (SD 10·0) to 3·5 (4·7); reductions among control participants were negligible (from 14·4 [12·4] to 13·7 [11·6]). Incidence of hypoglycaemic events decreased by 72% for participants in the rtCGM group (incidence rate ratio 0·28 [95% CI 0·20-0·39], p<0·0001). 18 serious adverse events were reported: seven in the control group, ten in the rtCGM group, and one before randomisation. No event was considered to be related to the investigational device. Usage of rtCGM reduced the number of hypoglycaemic events in individuals with type 1 diabetes treated by MDI and with impaired hypoglycaemia awareness or severe hypoglycaemia. Dexcom Inc.

Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization.

Real-time continuous glucose monitoring (rtCGM) improves glycemic control in type 1 diabetes (T1D) patients treated with continuous subcutaneous insulin infusion (CSII). However, the benefits of rtCGM in T1D patients treated with multiple daily insulin injection (MDI) therapy has not been well studied. We explored the effects of rtCGM versus self-monitoring of blood glucose (SMBG) on clinical outcomes within a large T1D population treated with either CSII or MDI therapy. This retrospective, longitudinal analysis utilized datasets from T1D patients enrolled in a commercial health plan to assess changes in HbA1c in 187 naïve to rtCGM users and 6260 SMBG users. Propensity score modeling was used to assess inpatient admissions, emergency room (ER) visits in 1130 patients (565 rtCGM, 565 SMBG). Differences in HbA1c reduction (rtCGM+MDI vs rtCGM+CSII) were evaluated. Larger, clinically meaningful HbA1c reductions were seen among rtCGM versus SMBG users: -0.5% ( P = .004) versus -0.2% ( P < .0001); 0.3% diff in diff, P = .03. All-cause inpatient admissions were lower for rtCGM users: -42%, P = .013. Emergency room visits coded for diabetic ketoacidosis (DKA) were four times higher for SMBG patients than rtCGM patients: 17 versus 4, P = .0318. HbA1c reductions were most notable with rtCGM+MDI versus rtCGM+CSII treatment: -0.6% ( P = .01) versus -0.3% ( P = .16). Use of rtCGM in T1D patients facilitates greater HbA1c improvements and reduced health care system utilization compared with traditional SMBG use regardless of insulin administration method. Treatment with rtCGM in conjunction with MDI confers similar or greater glycemic benefits without the additional costs associated with CSII therapy.

Recommendations for Using Real-Time Continuous Glucose Monitoring (rtCGM) Data for Insulin Adjustments in Type 1 Diabetes.

The clinical benefits of real time continuous glucose monitoring (rtCGM) use have been well demonstrated in both CSII- and MDI-treated individuals in large clinical trials. However, recommendations for patient use of rtCGM in everyday life situations are lacking. This article provides guidance to clinicians and patients with type 1 diabetes (T1D) in effective use of rtCGM data, including glucose rate of change (ROC) arrows, for insulin dosing adjustments and other treatment decisions. The recommendations presented here are based on our own clinical experiences as endocrinologists, our personal experiences living with T1D using rtCGM, and findings from a recent survey of T1D patients who have successfully used rtCGM in their self-management. It is important that both clinicians and people with diabetes understand the utility and limitations of rtCGM. Maintaining a collaborative clinician-user relationship remains an important factor in safe, successful rtCGM use.

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

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

Diabetes technology and the human factor.

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.

Perceived accuracy in continuous glucose monitoring: understanding the impact on patients.

In terms of accuracy and reliability, the technology of real-time (RT) continuous glucose monitoring (CGM) is advancing quickly. Still, current devices are imperfect; as a result, patient complaints and frustrations are not uncommon. How do patients' perceptions of device accuracy affect their experience with RT-CGM? In this article, we argue that patients' satisfaction, or dissatisfaction, with accuracy has a major impact on how much they are likely to trust the device and how confident they may feel in using the information that is displayed. The available data suggest that greater satisfaction with accuracy is linked to better RT-CGM adherence, more confident and aggressive insulin adjustments, improvements in quality of life, reduced reliance on self-monitoring of blood glucose, and--potentially--less alarm fatigue. As the technology continues to mature, RT-CGM will become increasingly accurate and patients' confidence and trust in the available devices will likely grow, leading to greater uptake and more proactive use of RT-CGM.

Real-Time Continuous Glucose Monitoring or Continuous Subcutaneous Insulin Infusion, What Goes First?: Results of a Pilot Study

Dual devices allow both continuous subcutaneous insulin infusion (CSII) and real-time (RT) continuous glucose monitoring (CGM). Patients usually start with CSII, adding RT-CGM later (CGM post-CSII). Lack of use of RT-CGM is the main limiting factor of dual device results. Initiating RT-CGM before CSII (CGM pre-CSII) could increase RT-CGM frequency use and further improve glycemic control. In this 26-week pilot study, we randomly assigned, via sealed envelopes, 16 CSII and RT-CGM to naive patients 14 years of age or older with type 1 diabetes mellitus (T1DM) to CGM post-CSII or CGM pre-CSII. The Paradigm® Veo™ (Medtronic Inc., Northridge, CA) was the dual device used in all patients. The primary end point was frequency of use of RT-CGM between both groups at week 26. We detected a significant higher RT-CGM frequency use in the CGM pre-CSII group at week 26 (78.4±10.9% vs. 56.0±40.8%; P=0.01), although we did not detect hemoglobin A1c level differences. In addition, CGM pre-CSII patients presented less time in hypoglycemia (average daily area under curve <70 mg/dL per 24 h, 0.87±1.02 mg/dL/day vs. 3.32±2.19 mg/dL/day; P=0.021), and no severe hypoglycemia events were detected during 26 weeks in this group. CGM pre-CSII is effective in increasing RT-CGM frequency use in T1DM patients. This is accompanied by a significant reduction in time in hypoglycemia.

MANAGEMENT OF ENDOCRINE DISEASE: Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials

Real-time continuous glucose monitoring (RT-CGM) provides detailed information on glucose patterns and trends, thus allowing the patients to manage their diabetes more effectively. The aim of this study was to explore the potential beneficial effects of the use of RT-CGM on diabetes management compared with self blood glucose measurement (SBGM) in patients with type 1 diabetes mellitus (T1DM), by means of a systematic review and meta-analysis of randomized controlled trials (RCTs). MEDLINE, EMBASE, and the Cochrane Library were searched through by two independent investigators for RCTs concerning the use of RT-CGM in patients with T1DM. Only studies with a similar insulin regimen in the experimental and control groups were included in the analysis. Seven RCTs (n=948) met the inclusion criteria. Combined data from all studies showed better HbA1c reduction in subjects using RT-CGM compared with those using SBGM (mean difference (MD) -0.25; 95% confidence interval (95% CI): from -0.34 to -0.17; P<0.001). Patients treated with insulin pump and RT-CGM had a lower HbA1c level compared with subjects managed with insulin pump and SBGM (four RCTs, n=497; MD -0.26; 95% CI: from -0.43 to -0.10; P=0.002). The benefits of applying RT-CGM were not associated with an increasing rate of major hypoglycemic episodes. The use of RT-CGM for over 60-70% of time was associated with a significant lowering of HbA1c. RT-CGM is more beneficial than SBGM in reducing HbA1c in patients with type 1 diabetes. Further studies are needed to evaluate the efficacy of this system in the pediatric population, especially in very young children.

Use of Short-Term Real-Time Continuous Glucose Monitoring in Type 1 Diabetes Patients on Continuous Intraperitoneal Insulin Infusion: A Feasibility Study

In diabetes, strict glycemic control reduces risk of complications. One mode of therapy is continuous intraperitoneal insulin infusion (CIPII). With CIPII, like all intensified treatment strategies, frequent assessment of glucose levels is mandatory. Real-time (RT)-continuous glucose monitoring (CGM) gives RT information without the need for multiple invasive measurements. In theory, CIPII combined with RT-CGM could provide near normal glucose profiles. The objective of this study is to investigate effectiveness and safety of RT-CGM in patients treated with intraperitoneal insulin through an implanted pump. In an open-label, crossover, randomized study, effects of 6-day open RT-CGM use were studied in 12 type 1 diabetes patients on CIPII, with blinded RT-CGM used as a control. Primary outcome was time in euglycemia. Secondary outcomes included time in other glucose ranges, incidence of adverse events, and patient satisfaction. Agreement of self-measurement of blood glucose (SMBG) and RT-CGM measurements was assessed. Median time spent in euglycemia was 68.2% (55.9-72.3%) with open RT-CGM and 64.9% (55.3-71.2%) with blinded RT-CGM (P = 0.25). Time spent in other glucose ranges did not differ (P > 0.05). There were no serious adverse events. Patient satisfaction was good. Median relative absolute difference of SMBG and RT-CGM values was 13.9%. Bland-Altman analysis showed a mean difference of -0.31 mg/dL with lower and upper limits of agreement of -77.0 and +76.4 mg/dL, respectively. Short-term use of RT-CGM, although safe and with good patient satisfaction, does not result in more time spent in euglycemia, nor does it change time spent in other glucose ranges in our population of type 1 diabetes patients receiving CIPII.

JDRF Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes: Research Design and Methods

While real-time (RT) continuous glucose monitoring (CGM) systems may revolutionize treatment of type 1 diabetes (T1D), there is insufficient evidence currently available to support widespread utilization of these devices. The Juvenile Diabetes Research Foundation (JDRF) CGM Study Group developed a randomized clinical trial to determine if RT-CGM can improve glycemic control and quality of life in children and adults with T1D. This paper presents the research design and methods that are being employed in this study. The JDRF CGM Study Group trial is a randomized, parallel group, efficacy and safety study. Subjects with T1DM who meet eligibility criteria are randomized to either standard self-monitoring of blood glucose (SMBG) alone or use of any of the three current RT-CGM systems as a supplement to SMBG. After the 6-month randomized period, the Control Group is offered use of RT-CGM, and both groups are studied for an additional 6 months. Subjects are divided into two cohorts: the Main Study Cohort includes subjects with baseline glycosylated hemoglobin (HbA1c) 7.0-10.0% inclusive, and the Exploratory Pilot Study Cohort includes subjects with HbA1c<7.0%. Difference in HbA1c is the primary outcome in the Main Study. Other outcomes include the percentage of sensor glucose values within the 70-180 mg/dL range, scores on questionnaires that assess the impact of RT-CGM on living with T1D, and the cost-effectiveness of RT-CGM. Recruitment for the study was completed on December 15, 2007. Results of this clinical trial should help establish whether or not current RT-CGM devices are beneficial to patients with T1D.