scholarly journals Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0248965
Author(s):  
Andrzej Gawrecki ◽  
Dorota Zozulinska-Ziolkiewicz ◽  
Magdalena A. Michalak ◽  
Anna Adamska ◽  
Michal Michalak ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Body Weight ◽  
Closed Loop ◽  
Insulin Pump ◽  
Severe Hypoglycemia ◽  
Insulin Requirement ◽  
Time In Range ◽  
Do It Yourself ◽  
Glycemic Outcomes

Background The aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D). Methods Single-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70–180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight. Results In total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7–34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0–19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3–145.9) vs. 153.3 ± 17.9, 95%CI(143.2–163.4), mg/dl p<0.001). TIR 70–180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%–-0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70–180 mg/dl 82.1 ± 5.6%, 95%CI(78.9–85.3), time <54 mg/dl 0.30 (0.20–0.55)%, median 95%CI(0.1–0.7) and <70 mg/dl 1.90 (1.10–3.05)%, median 95%CI(0.7–3.2). The insulin requirement and body weight did not change in the study. Conclusions The study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control. Trial registration German Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.

1066-P: Improvement in Time-in-Range (TIR) with Real-Life Use of Hybrid Closed-Loop System in Patients with Type 1 Diabetes (T1D)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1066-P
Author(s):  
HALIS K. AKTURK ◽  
DOMINIQUE A. GIORDANO ◽  
HAL JOSEPH ◽  
SATISH K. GARG ◽  
JANET K. SNELL-BERGEON
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Real Life ◽  
Loop System ◽  
Closed Loop System ◽  
Time In Range

Time in range for multiple technologies in type 1 diabetes: a systematic review and network meta-analysis

2020 ◽  
Author(s):  
Anthony Pease ◽  
Clement Lo ◽  
Arul Earnest ◽  
Velislava Kiriakova ◽  
Danny Liew ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Meta Analysis ◽  
Management Strategies ◽  
Glucose Testing ◽  
Closed Loop Systems ◽  
Percent Time ◽  
Time In Range

<b>Background: </b>Time-in-range is a key glycaemic metric, and comparisons of management technologies for this outcome are critical to guide device selection. <p><b> </b></p> <p><b>Purpose: </b>We conducted a systematic review and network meta-analysis to compare and rank technologies for time in glycaemic ranges.</p> <p> </p> <p><b>Data sources: </b>We searched All Evidenced Based Medicine Reviews, CINAHL, EMBASE, MEDLINE, MEDLINE In-Process and other non-indexed citations, PROSPERO, PsycINFO, PubMed, and Web of Science until 24 April, 2019.</p> <p> </p> <p><b>Study selection: </b>We included randomised controlled trials <u>></u>2 weeks duration comparing technologies for management of type 1 diabetes in adults (<u>></u>18 years of age), excluding pregnant women. </p> <p> </p> <p><b>Data extraction: </b>Data were extracted using a predefined template. Outcomes were percent time with sensor glucose levels 3.9–10.0mmol/l (70–180mg/dL), >10.0mmol/L (180mg/dL), and <3.9mmol/L (70mg/dL). </p> <p><b> </b></p> <p><b>Data synthesis: </b>We identified 16,772 publications, of which 14 eligible studies compared eight technologies comprising 1,043 participants. Closed loop systems lead to greater percent time-in-range than any other management strategy and was 17.85 (95% predictive interval [PrI] 7.56–28.14) higher than usual care of multiple daily injections with capillary glucose testing. Closed loop systems ranked best for percent time-in-range or above range utilising surface under the cumulative ranking curve (SUCRA–98.5 and 93.5 respectively). Closed loop systems also ranked highly for time below range (SUCRA–62.2). </p> <p><b> </b></p> <p><b>Limitations: </b>Overall risk of bias ratings were moderate for all outcomes. Certainty of evidence was very low.</p> <p><b> </b></p> <p><b>Conclusions: </b>In the first integrated comparison of multiple management strategies considering time-in-range, we found that the efficacy of closed loop systems appeared better than all other approaches. </p>

scholarly journals Improved Time-in-Range over 1 year is Associated with Reduced Albuminuria in Individuals with Sensor-Augmented Insulin Pump-Treated Type 1 Diabetes

2020 ◽  
Author(s):  
Ajenthen G. Ranjan ◽  
Signe V. Rosenlund ◽  
Tine W. Hansen ◽  
Peter Rossing ◽  
Steen Andersen ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Insulin Pump ◽  
Controlled Trial ◽  
Daily Injection ◽  
Albumin Creatinine Ratio ◽  
Multiple Daily Injection ◽  
Blood And Urine Samples ◽  
Time In Range ◽  
One Year

<b>Aim:</b> To investigate the association between treatment-induced change in continuous glucose monitored (CGM) time-in-range (TIR) and albuminuria in persons with type 1 diabetes (T1D) treated with sensor-augmented-pumps (SAP). <p><b>Methods: </b><a></a><a>Twenty-six of fifty-five participants with albuminuria and multiple daily injection-therapy (25% females, 51 (46-63) years, HbA<sub>1c</sub> 75 (68-88) mmol/mol [9.0 (8.4-10.4)%], UACR 89 (37-250) mg/g) were in a randomized-controlled trial assigned to SAP-therapy for one year</a>. Anthropometrics, CGM-data, blood and urine samples were collected every three months.</p> <p><b>Results: </b>Mean change (95%-CI) in %TIR was +13.2 (6.2;20.2)%, HbA<sub>1C</sub> was -14.4 (-17.4;-10.5) mmol/mol [-1.3 (-1.6;-1.0)%] and urinary albumin-creatinine-ratio (UACR) was -15 (-38;17)%, all p<0.05. UACR decreased with 19 (10;28)% per 10% increase in %TIR (p=0.04), 18 (1;30)% per 10 mmol/mol decrease in HbA<sub>1C</sub> (p=0.07), and 31% per 10 mmHg decrease in mean arterial pressure (p<0.001).<b></b></p> <b>Conclusion: </b>In this longitudinal study, treatment-induced increase in %TIR was significantly associated with decrease in albuminuria in T1D.

Open-source automated insulin delivery systems for the management of type 1 diabetes during pregnancy

2021 ◽  
Vol 14 (9) ◽  
pp. e243522
Author(s):  
Khulood Bukhari ◽  
Rana Malek
Keyword(s):  
Type 1 Diabetes ◽  
Open Source ◽  
Closed Loop ◽  
Glycated Hemoglobin ◽  
Insulin Delivery ◽  
Third Trimester ◽  
Time In Range ◽  
Insulin Delivery System ◽  
Iphone Application

A 40-year-old woman used an open-source automated insulin delivery system to manage her type 1 diabetes (T1D) prior to conception. The code for building the iPhone application called ‘Loop’ that carried the software for the hybrid closed-loop controller was available online. Her glycated hemoglobin before conception was 6.4%. Between 6 and 12 weeks gestation, she spent 66% time-in-range (TIR), 28% time-above-range (TAR) and 6% time-below-range (TBR). Between 18 and 24 weeks gestation, she spent 68% TIR, 27% TAR and 5% TBR. During her third trimester, she spent 72% TIR, 21% TAR and 7% TBR. She delivered a healthy infant with no neonatal complications. Clinicians should be aware of this technology as it gains traction in the T1D community and seeks Food and Drug Administration approval.

Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up

2021 ◽  
Author(s):  
Coralie Amadou ◽  
Sylvia Franc ◽  
Pierre-Yves Benhamou ◽  
Sandrine Lablanche ◽  
Erik Huneker ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Adverse Events ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
Real Life ◽  
Serious Adverse Events ◽  
Life Conditions ◽  
Time In Range

<b>OBJECTIVE </b> <p>To analyze safety and efficacy of the DBLG1 hybrid closed-loop artificial pancreas system in patients with Type 1 Diabetes in real life conditions. </p> <p> </p> <p><b>METHODS</b></p> <p>Following a one-week run-in period with usual pump, 25 patients were provided with the commercial DBLG1 system. We present the results of Time-in-Range and HbA1c over a 6-month period.</p> <p><b> </b></p> <p><b>RESULTS</b></p> <p>The mean (SD;range) age of patients was 43 years (13.8; 25-72). At baseline, mean HbA1c and TIR 70-180mg/dL were respectively 7.9% (0.93; 5.6- 8.5) [63mmol/mol (10; 38-69)] and 53% (16.4;21-85). One patient stopped using the system after 2 months. At 6-month, mean HbA1c decreased to 7.1% [54mmol/mol] (p<0.001) and TIR 70-180mg/dL increased to 69.7% (p<0.0001). TIR<70mg/dL decreased from 2.4 to 1.3% (p=0.03). TIR<54mg/dL decreased from 0.32 to 0.24% (p=0.42). No serious adverse event was reported during the study. </p> <p> </p> <p><b>CONCLUSION</b></p> <p>The DBLG1 System confirms its ability to significantly improve glycemic control in real life conditions, without serious adverse events. </p>

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