OBJECTIVE Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14–72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70–180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study. RESULTS All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = −6.0%; 95% CI −8.4%, −3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI −0.05%, 0.13%; P = 0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference −0.34% [−3.7 mmol/mol]; 95% CI −0.57% [−6.2 mmol/mol], −0.11% [1.2 mmol/mol]; P = 0.0035). CONCLUSIONS Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.
OBJECTIVE Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)–measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference −1.7% [95% CI −2.4, −1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference −3.0% [95% CI −6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.
<b>Objective: </b>To further evaluate the safety and efficacy of the Control-IQ closed loop control (CLC) system in children with type 1 diabetes.<b></b> <p><b>Research Design and Methods: </b>Following a 16-week randomized clinical trial (RCT) comparing CLC with sensor augmented pump (SAP) therapy in 101 children age 6 to 13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks. </p> <p><b>Results: </b>In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55±13% using SAP during the RCT to 65±10% using CLC (P<0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P=0.03). Substantial improvement in TIR was seen after the first day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P<0.001). In the CLC-CLC cohort, mean TIR increased from 53±17% pre-randomization to 67±10% during the RCT and remained reasonably stable at 66±10% through the 12-weeks post-RCT. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in either cohort.</p> <p><b>Conclusions: </b> This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6 to 13 years old with type 1 diabetes from the first day of use and demonstrates that these improvements can be sustained through 28 weeks of use. </p>
To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes.After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks.In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55 ± 13% using SAP during the RCT to 65 ± 10% using CLC (P < 0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P = 0.03). Substantial improvement in TIR was seen after the 1st day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P < 0.001). In the CLC-CLC cohort, mean TIR increased from 53 ± 17% prerandomization to 67 ± 10% during the RCT and remained reasonably stable at 66 ± 10% through the 12 weeks post-RCT. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either cohort.This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6-13 years old with type 1 diabetes from the 1st day of use and demonstrates that these improvements can be sustained through 28 weeks of use.
Continuous glucose monitors (CGMs) are an integral part of care for youth with type 1 diabetes (T1D) though lack FDA labeling for inpatient use. While some adult data on CGM use in inpatient settings is available, pediatric data are minimal. This retrospective chart review evaluated the accuracy of Dexcom G6 CGM versus point of care (POC, Nova Biomedical StatStrip [MARD 6%])) blood glucose values from pediatric inpatient encounters. Blood glucose data, diagnosis codes, and initial labs were collected from the medical record. CGM values were obtained from Dexcom Clarity CSV files. Paired glucose values (N=1191) from 83 patients with T1D (median age 12 yrs, 54% male, 69% non-Hispanic White) were used to calculate mean absolute relative difference (MARD) and Clarke Error Grid. Data from DKA admissions (N=665) had a MARD of 11.1% with 97.8% of values within A&B zones, compared to 11.4% and 98.5% for non-DKA admissions (N=526). Values from severe DKA admissions (N= 307) (pH <7.15 and/or bicarbonate <5 mmol/L) had a lower MARD compared to non-severe admissions (N=358) (8.4% vs 13.4%, p=0.01). In summary, CGM accuracy is comparable between DKA and non-DKA admissions. The accuracy of CGMs, even in severe DKA, suggests potential usability during pediatric hospital encounters. Further analysis will differentiate POC versus lab glucose and the effect of medications, including IV insulin infusions. Disclosure L.A.Waterman: None. L.Pyle: None. L.Towers: None. E.Jost: Other Relationship; Tandem Diabetes Care, Inc. A.J.Karami: None. C.Berget: Consultant; Insulet Corporation, Dexcom, Inc., Other Relationship; Tandem Diabetes Care, Inc. G.P.Forlenza: Advisory Panel; Medtronic, Consultant; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc., Lilly Diabetes, Research Support; Medtronic, Abbott, Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc. R.Wadwa: Consultant; Eli Lilly and Company, Other Relationship; Dexcom, Inc., Eli Lilly and Company, Research Support; Dexcom, Inc., Eli Lilly and Company, Beta Bionics, Inc., Tandem Diabetes Care, Inc. E.C.Cobry: None. Funding National Institutes of Health (5T32DK063687)
Importance Near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals. Objective To determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes. Design, Setting, and Participants This randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years. Interventions Random assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo. Main Outcomes and Measures The primary outcome was mixed-meal tolerance test–stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis. Results Among 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol/mL in the standard care group (treatment group difference, −0.01 [95% CI, −0.11 to 0.10]; P = .89). The mean time in the target range of 70 to 180 mg/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group. Conclusions and Relevance In youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks. Trial Registration ClinicalTrials.gov Identifier: NCT04233034
Background: Studies of closed-loop control (CLC) in patients with type 1 diabetes (T1D) consistently demonstrate improvements in glycemic control as measured by increased time-in-range (TIR) 70-180 mg/dL. However, clinical predictors of TIR in users of CLC systems are needed. Materials and Methods: We analyzed data from 100 children aged 6-13 years with T1D using the Tandem Control-IQ CLC system during a randomized trial or subsequent extension phase. Continuous glucose monitor data were collected at baseline and during 12-16 weeks of CLC use. Participants were stratified into quartiles of TIR on CLC to compare clinical characteristics. Results: TIR for those in the first, second, third, and fourth quartiles was 54%, 65%, 71%, and 78%, respectively. Lower baseline TIR was associated with lower TIR on CLC (r = 0.69, P < 0.001). However, lower baseline TIR was also associated with greater improvement in TIR on CLC (r = -0.81, P < 0.001). During CLC, participants in the highest versus lowest TIR-quartile administered more user-initiated boluses daily (8.5 ± 2.8 vs. 5.8 ± 2.6, P < 0.001) and received fewer automated boluses (3.5 ± 1.0 vs. 6.0 ± 1.6, P < 0.001). Participants in the lowest (vs. the highest) TIR-quartile received more insulin per body weight (1.13 ± 0.27 vs. 0.87 ± 0.20 U/kg/d, P = 0.008). However, in a multivariate model adjusting for baseline TIR, user-initiated boluses and insulin-per-body-weight were no longer significant. Conclusions: Higher baseline TIR is the strongest predictor of TIR on CLC in children with T1D. However, lower baseline TIR is associated with the greatest improvement in TIR. As with open-loop systems, user engagement is important for optimal glycemic control.
Background: Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Methods: Participants were randomized 2:1 to CLC (N = 112) versus SAP (N = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS). Results: The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores. Conclusion: CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.
<b>Objective: </b>To further evaluate the safety and efficacy of the Control-IQ closed loop control (CLC) system in children with type 1 diabetes.<b></b> <p><b>Research Design and Methods: </b>Following a 16-week randomized clinical trial (RCT) comparing CLC with sensor augmented pump (SAP) therapy in 101 children age 6 to 13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks. </p> <p><b>Results: </b>In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55±13% using SAP during the RCT to 65±10% using CLC (P<0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P=0.03). Substantial improvement in TIR was seen after the first day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P<0.001). In the CLC-CLC cohort, mean TIR increased from 53±17% pre-randomization to 67±10% during the RCT and remained reasonably stable at 66±10% through the 12-weeks post-RCT. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in either cohort.</p> <p><b>Conclusions: </b> This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6 to 13 years old with type 1 diabetes from the first day of use and demonstrates that these improvements can be sustained through 28 weeks of use. </p>
Quality sleep is important for youth with type 1 diabetes (T1D) and their parents, yet disrupted sleep due to diabetes-related awakenings is common. Increased time-in-range (TIR, 70-180 mg/dL) and decreased time in hypoglycemia (<70 mg/dL) may positively affect sleep. This analysis evaluated associations between glycemia and sleep measures.Youth age 3-17 years in an observational study had sleep and glycemic data collected. TIR and time in hypoglycemia throughout the day were compared with actigraphy data, including total sleep time (TST), sleep efficiency, wake after sleep onset (WASO), and number of awakenings. Linear mixed models were used to test associations between sleep variables with TIR and hypoglycemia.Twenty-six youth with T1D (mean age 10.7±4.0 yrs, median T1D duration 2.0 yrs [IQR 0.6, 4.8], HbA1c 7.2±1.4%, 50% female) and a parent were included. Significant associations were found between hypoglycemia and child WASO, awakenings, and TST. No associations were observed between TIR and sleep measures (Table 1).Time in hypoglycemia was associated with more nocturnal awakenings and WASO in youth with T1D. The association between hypoglycemia and child TST is unexpected and requires further evaluation. A larger sample size is needed to further evaluate correlations between glycemic outcomes and sleep measures. Tools to decrease hypoglycemia are important to improve sleep quality for youth with T1D.View largeDownload slideView largeDownload slide DisclosureA. J. Karami: None. L. Pyle: None. E. Jost: None. R. Wadwa: Consultant; Self; Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care. L. J. Meltzer: None. E. C. Cobry: None.FundingNational Institutes of Health (K12DK094712)
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