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Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial.
Benhamou, PY, Franc, S, Reznik, Y, Thivolet, C, Schaepelynck, P, Renard, E, Guerci, B, Chaillous, L, Lukas-Croisier, C, Jeandidier, N, et al
The Lancet. Digital health. 2019;(1):e17-e25
Abstract
BACKGROUND Closed-loop insulin delivery systems are expected to become a standard treatment for patients with type 1 diabetes. We aimed to assess whether the Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system improved glucose control compared with sensor-assisted pump therapy. METHODS In this multicentre, open-label, randomised, crossover trial, we recruited adults (aged ≥18 years) with at least a 2 year history of type 1 diabetes, who had been treated with external insulin pump therapy for at least 6 months, had glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol), and preserved hypoglycaemia awareness. After a 2-week run-in period, patients were randomly assigned (1:1) with a web-based system in randomly permuted blocks of two, to receive insulin via the hybrid closed-loop system (DBLG1; using a machine-learning-based algorithm) or sensor-assisted pump therapy over 12 weeks of free living, followed by an 8-week washout period and then the other intervention for 12 weeks. The primary outcome was the proportion of time that the sensor glucose concentration was within the target range (3·9-10·0 mmol/L) during the 12 week study period. Efficacy analyses were done in the modified intention-to-treat population, which included all randomly assigned patients who completed both 12 week treatment periods. Safety analyses were done in all patients who were exposed to either of the two treatments at least once during the study. This trial is registered with ClinicalTrials.gov, number NCT02987556. FINDINGS Between March 3, 2017, and June 19, 2017, 71 patients were screened, and 68 eligible patients were randomly assigned to the DBLG1 group (n=33) or the sensor-assisted pump therapy group (n=35), of whom five dropped out in the washout period (n=1 pregnancy; n=4 withdrew consent). 63 patients completed both 12 week treatment periods and were included in the modified intention-to-treat analysis. The proportion of time that the glucose concentration was within the target range was significantly higher in the DBLG1 group (68·5% [SD 9·4] than the sensor-assisted pump group (59·4% [10·2]; mean difference 9·2% [95% CI 6·4 to 11·9]; p<0·0001). Five severe hypoglycaemic episodes occurred in the DBLG1 group and three episodes occurred in the sensor-assisted pump therapy group, which were associated with hardware malfunctions or human error. INTERPRETATION The DBLG1 system improves glucose control compared with sensor-assisted insulin pumps. This finding supports the use of closed-loop technology combined with appropriate health care organisation in adults with type 1 diabetes. FUNDING French Innovation Fund, Diabeloop.
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Mediation of the association of smoking and microvascular complications by glycemic control in type 1 diabetes.
Braffett, BH, Rice, MM, Young, HA, Lachin, JM
PloS one. 2019;(1):e0210367
Abstract
Studies have demonstrated the adverse effects of smoking on the risk of microvascular complications; however, few have also examined the potential mediating effects of glycemic control. Using data from the Diabetes Control and Complications Trial (DCCT 1983-1993), we describe the acute and long-term risks of smoking on glycemic control and microvascular complications in a well-characterized cohort of participants with type 1 diabetes. The DCCT recorded self-reported smoking behaviors, glycemic exposure based on HbA1c, and complications status. Generalized linear mixed models were used to assess whether time-dependent measurements of smoking predict HbA1c levels. Cox proportional hazard models were used to assess time-dependent smoking exposures as predictors of retinopathy and nephropathy. During a mean of 6.5 years of follow-up, current smokers had consistently higher HbA1c values and were at a higher risk of retinopathy and nephropathy compared with former and never smokers. These risk differences were attenuated after adjusting for HbA1c suggesting that the negative association of smoking on glycemic control is partially responsible for the adverse association of smoking on the risk of complications in type 1 diabetes. These findings support the potential for a beneficial effect of smoking cessation on complications in type 1 diabetes.
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Glycemic profile assessment during betamethasone administration in women with gestational diabetes mellitus.
Kakoulidis, I, Ilias, I, Linardi, A, Milionis, C, Michou, A, Koukkou, E
Diabetes & metabolic syndrome. 2019;(1):214-215
Abstract
AIM: Betamethasone's effect on glucose homeostasis in the presence of gestational diabetes has not been adequately investigated. MATERIALS-METHODS We assessed the glycemic profile of 99 women with gestational diabetes (52 on insulin, 47 on medical nutrition therapy) who were given betamethasone during hospitalization for at risk pregnancies. RESULTS In insulin-treated women the increase in total daily insulin dose significantly linked to betamethasone dose (p = 0.014). In women on diet, the need for insulin was positively related to betamethasone dose, age and gestational age >34th week (all p < 0.05). CONCLUSION Parsimonious betamethasone use might still be beneficial with a milder effect on glycemia.
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A Model-Based Meta-Analysis of 24 Antihyperglycemic Drugs for Type 2 Diabetes: Comparison of Treatment Effects at Therapeutic Doses.
Maloney, A, Rosenstock, J, Fonseca, V
Clinical pharmacology and therapeutics. 2019;(5):1213-1223
Abstract
Model-based meta-analysis was used to compare glycemic control, weight changes, and hypoglycemia risk across 24 antihyperglycemic drugs used to treat type 2 diabetes. Electronic searches identified 229 randomized controlled studies comprising 121,914 patients. To ensure fair and unbiased treatment comparisons, the analyses adjusted for important differences between studies, including duration of treatment, baseline glycated hemoglobin, and drug dosages. At the approved doses, glycemic control was typically greatest with glucagon-like peptide 1 receptor agonists (GLP-1RAs), and least with dipeptidyl peptidase-4 (DPP-4) inhibitors. Weight loss was highly variable across GLP-1RAs but was similar across sodium-glucose cotransporter 2 (SGLT2) inhibitors. Large weight increases were observed with sulfonylureas and thiazolidinediones. Hypoglycemia risk was highest with sulfonylureas, although gliclazide was notably lower. Hypoglycemia risk for DPP-4 inhibitors, SGLT2 inhibitors, and thiazolidinediones was generally very low but increased slightly for both GLP-1RAs and metformin. In summary, important differences between and within drug classes were identified.
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Possible relation between partial small bowel obstruction and severe postprandial reactive hypoglycemia after Roux-en-Y gastric bypass.
Laurenius, A, Hedberg, S, Olbers, T
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2019;(6):1024-1028
Abstract
BACKGROUND Although dietary treatment ameliorates symptoms in most patients with postbariatric hypoglycemia (PBH), there is a subgroup with severe symptoms that do not respond sufficiently to either diet or drugs. A clinical observation showed that those patients additionally experienced postprandial abdominal discomfort or pain. OBJECTIVES This report describes patients with severe PBH following laparoscopic Roux-en Y gastric bypass undergoing corrective surgery to alleviate partial small bowel obstruction (kink, adhesions, dysfunctional anastomosis) and the subsequent outcome regarding symptoms of PBH. SETTING Sahlgrenska University Hospital, Sweden. METHODS Retrospective analysis regarding hypoglycemic symptoms from medical records and a complementary telephone interview. RESULTS Out of 80 patients treated for severe PBH at our tertiary academic surgical unit over the last 4 years, 38 underwent corrective surgery (adhesiolysis and/or a reconstructed jejuno-jejunostomy). Out of 21 patients using medications to control hypoglycemia before corrective surgery, 19 (90.5%) discontinued the medication, and 5 of 19 (26%) no longer needed to use a blood glucometer or a continuous glucose monitor. Although patients after surgical correction still could experience PBH, symptoms were less frequent and less severe. Postprandial abdominal symptoms decreased, and patients reported improved eating quality. Patient interviews revealed that 8% became entirely free of PBH symptoms after surgery and 71% experienced significant relief. CONCLUSIONS We propose a possible association between severe hypoglycemic symptoms after laparoscopic Roux-en Y gastric bypass and partial small bowel obstruction. Patients with PBH not responding adequately to diet and drug treatment may benefit from assessment and intervention for partial small bowel obstruction.
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Reduction in insulin degludec dosing for multiple exercise sessions improves time spent in euglycaemia in people with type 1 diabetes: A randomized crossover trial.
Moser, O, Eckstein, ML, Mueller, A, Birnbaumer, P, Aberer, F, Koehler, G, Sourij, C, Kojzar, H, Holler, P, Simi, H, et al
Diabetes, obesity & metabolism. 2019;(2):349-356
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Abstract
AIMS: To compare the time spent in specified glycaemic ranges in people with type 1 diabetes (T1D) during 5 consecutive days of moderate-intensity exercise while on either 100% or 75% of their usual insulin degludec (IDeg) dose. MATERIALS AND METHODS Nine participants with T1D (four women, mean age 32.1 ± 9.0 years, body mass index 25.5 ± 3.8 kg/m2 , glycated haemoglobin 55 ± 7 mmol/mol (7.2% ± 0.6%) on IDeg were enrolled in the trial. Three days before the first exercise period, participants were randomized to either 100% or 75% of their usual IDeg dose. Participants exercised on a cycle ergometer for 55 minutes at a moderate intensity for 5 consecutive days. After a 4-week wash-out period, participants performed the last exercise period for 5 consecutive days with the alternate IDeg dose. Time spent in specified glycaemic ranges, area under the curve and numbers of hypoglycaemic events were compared for the 5 days on each treatment allocation using a paired Students' t test, Wilcoxon matched-pairs signed-rank test and two-way ANOVA. RESULTS Time spent in euglycaemia over 5 days was greater for the 75% IDeg dose versus the 100% IDeg dose (4008 ± 938 minutes vs. 3566 ± 856 minutes; P = 0.04). Numbers of hypoglycaemic events (P = 0.91) and time spent in hypoglycaemia (P = 0.07) or hyperglycaemia (P = 0.38) was similar for both dosing schemes. CONCLUSIONS A 25% reduction in usual IDeg dose around regular exercise led to more time spent in euglycaemia, with small effects on time spent in hypo- and hyperglycaemia.
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Identification and Management of Neonatal Hypoglycemia in the Full-Term Infant. British Association of Perinatal Medicine Framework for Practice, 2017.
Hawdon, JM
Journal of human lactation : official journal of International Lactation Consultant Association. 2019;(3):521-523
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Use of flash glucose monitoring system in assessing safety of the SGLT2 inhibitors during Ramadan fasting in high risk insulin treated patients with type 2 diabetes.
Abdelgadir, E, Rashid, F, Bashier, A, Al Saeed, M, Khalifa, A, Alawadi, F, Hassanein, M
Diabetes & metabolic syndrome. 2019;(5):2927-2932
Abstract
BACKGROUND The risks of hypoglycemia, dehydration and kidney injury may theoretically be aggravated by people with type 2 diabetes treated with Insulin and SGLT2 inhibitors during Ramadan. Data on safety and efficacy of SGLT2-I in people with type 2 diabetes treated with insulin is scanty. We aimed to assess the impact of SGLT2 inhibitors during Ramadan in high-risk patients with type 2 diabetes treated with insulin, on hypoglycemia, glycemic control and kidney function. METHODS This is a prospective interventional study on high-risk diabetes patients who insisted on fasting. All patients were treated with insulin ± SGLT2I. All patients received a FGMS and Ramadan focused education. All patients attended clinic before and post Ramadan where they were advised on treatment modification as well as biometric and biochemical measurements. RESULTS 95 patients enrolled in the study and 49 of them were on SGLT2i. There was a no significant change in creatinine in both groups. FGMS showed an improvement in the sensor-calculated HbA1c from 7.3 ± 1.5 to 6.8 ± 1.1 and from 8 ± 1.6 to 7.7 ± 1.5 in the SGLT2 group and the non-SGT2i groups, respectively. The hypoglycemia was predominantly reported during Ramadan between 12:00 to 18:00 h, while in pre-Ramadan readings was during 2400-0600 and 1200-1800 slots. CONCLUSIONS This is the first study that assesses the use of SGLT2i along with insulin during Ramadan, using FGMS in high-risk patients with type 2 diabetes under optimal care. There was minimal interruption of fasting, significant improvement in glycemic control, and no significant change in the kidney function after Ramadan.
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Anthropometric outcomes in type 2 diabetic patients with new dapagliflozin treatment; actual clinical experience data of six months retrospective glycemic control from single center.
Calapkulu, M, Cander, S, Gul, OO, Ersoy, C
Diabetes & metabolic syndrome. 2019;(1):284-288
Abstract
INTRODUCTION Dapagliflozin is an antidiabetic drug that has been used as a member of the new antidiabetic drug group that acts by inhibiting SGLT-2 and increasing urinary glucose excretion. With numerous controlled experimental studies of dapagliflozin, evaluation of real-life data after entry into clinical practice is an important condition. In our study, the effects of dapagliflozin on glycemic control and anthropometric measurements were investigated retrospectively. METHODS A-total of thirty-one type 2 diabetics were enrolled in the study. Data of before dapagliflozin and three and six months of treatment were recorded. RESULTS Dapagliflozin reduced HbA1c levels by 0,9% at 3 months and 0,79% at 6 months. Fasting plasma glucose decreased 41,1 mg/dl in the 3rd and 42 mg/dl in the 6th, postprandiyal glucose decreased 86,3 mg/dl in the 3rd and 74,2 mg/dl in the 6th. In the 3rd and 6th, body weights decreased by 3,3 kg and 4,2 kg, BMI decreased by 1,3 kg/m2 and 1,6 kg/m2 respectively. Similarly, it was observed that the waist circumference decreased by 1,3 cm at the end of 6th. CONCLUSION Our data show that SGLT-2 inhibitors provide glycemic control with reduce HbA1c levels by 0.8-0.9%, and reduce fasting and postprandial plasma glucose levels without increasing the risk of hypoglycemia and causing weight lose around 5% at the six mounths. SGLT-2 inhibitors were found to be more effective in reduce postprandiyal plasma glucose in patients who did not use insulin and fasting plasma glucose in patients with diabetes mellitus less than 10 years.
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Safety of Ramadan fasting in young patients with type 1 diabetes: A systematic review and meta-analysis.
Loh, HH, Lim, LL, Loh, HS, Yee, A
Journal of diabetes investigation. 2019;(6):1490-1501
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Abstract
AIMS/INTRODUCTION Although patients with type 1 diabetes are medically exempt, many insist on fasting during Ramadan. Multiple daily insulin injections (MDI), premixed insulin and continuous subcutaneous insulin infusion (CSII) are commonly used. To date, little is known about the safety of Ramadan fasting in these patients. MATERIALS AND METHODS We pooled data from 17 observational studies involving 1,699 patients treated with either CSII or non-CSII (including premixed and MDI) regimen. The study outcomes were the frequencies of hypoglycemia, hyperglycemia and/or ketosis. Given the lack of patient-level data, separate analyses for premixed and MDI regimen were not carried out. RESULTS The CSII-treated group (n = 203) was older (22.9 ± 6.9 vs 17.8 ± 4.0 years), and had longer diabetes duration (116.7 ± 66.5 vs 74.8 ± 59.2 months) and lower glycated hemoglobin (7.8 ± 1.1% vs 9.1 ± 2.0%) at baseline than the non-CSII-treated group (n = 1,496). The non-CSII-treated group had less non-severe hypoglycemia than the CSII-treated group (22%, 95% CI 13-34 vs 35%, 95% CI 17-55). Of the non-CSII-treated group, 7.1% (95% CI 5.8-8.5) developed severe hypoglycemia, but none from the CSII-treated group did. The non-CSII-treated group was more likely to develop hyperglycemia (12%, 95% CI 3-25 vs 8.8%, 95% CI 0-31) and ketosis (2.5%, 95% CI 1.0-4.6 vs 1.6%, 95% CI 0.1-4.7), and discontinue fasting (55%, 95% CI 34-76 vs 31%, 95% CI 9-60) than the CSII-treated group. CONCLUSIONS The CSII regimen had lower rates of severe hypoglycemia and hyperglycemia/ketosis, but a higher rate of non-severe hyperglycemia than premixed/MDI regimens. These suggest that appropriate patient selection with regular, supervised fine-tuning of the basal insulin rate with intensive glucose monitoring might mitigate the residual hypoglycemia risk during Ramadan.