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Addition of canagliflozin to insulin improves glycaemic control and reduces insulindose in patients with type 2 diabetes mellitus: A randomized controlled trial The aim of this study was to evaluate the efficacy of canagliflozin in reducing the required insulindose and the risk of hypoglycaemia in type 2 diabetes (T2D). This study was conducted in patients with T2D treated with insulin. They were randomly assigned to the control (n = 17) and canagliflozin (n = 17, plus 100 mg/day (...) canagliflozin) groups. In both groups, a defined insulindose adjustment protocol was applied to achieve the same level of glycaemic control. The change from baseline in daily insulindose was significantly smaller in the canagliflozin group (3.9 units/day) than in the control group (13.4 units/day; P = 0.040). Low blood glucose index and predicted % of blood glucose (BG) <70 mg/dL, which are hypoglycaemia-related variables, worsened significantly in the control group but both remained unchanged
Automated insulindosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial. Insulin therapy is most effective if dosage titrations are done regularly and frequently, which is seldom practical for most clinicians, resulting in an insulin titration gap. The d-Nav Insulin Guidance System (Hygieia, Livonia, MI, USA) is a handheld device that is used to measure glucose, determine glucose patterns, and automatically determine (...) the appropriate next insulindose. We aimed to determine whether the combination of the d-Nav device and health-care professional support is superior to health-care professional support alone.In this multicentre, randomised, controlled study, we recruited patients from three diabetes centres in the USA (in Detroit MI; Minneapolis, MN; and Des Moines IA). Patients were eligible if they were aged 21-70 years, diagnosed with type 2 diabetes with a glycated haemoglobin (HbA1c) concentration of 7·5% or higher (≥58
2019LancetControlled trial quality: predicted high
Treatment of Hyperkalemia With a Low-DoseInsulin Protocol Is Effective andÂ Results in ReducedÂ Hypoglycemia Complications associated with insulin treatment for hyperkalemia are serious and common. We hypothesize that, in chronic kidney disease (CKD) and end-stage renal disease (ESRD), giving 5 units instead of 10 units of i.v. regular insulin may reduce the risk of causing hypoglycemia when treating hyperkalemia.A retrospective quality improvement study on hyperkalemia management (K+ ≥ 6 mEq (...) patients. A second audit of hyperkalemia management from July 2015 through January 2016 was conducted to assess the effects of intervention on hypoglycemia incidence.Treatments ordered using a protocol for hyperkalemia increased following the educational intervention (58 of 78 patients [74%] vs. 62 of 99 patients [62%]), and the number of CKD/ESRD patients prescribed 5 units of insulin as per protocol increased (30 of 32 patients [93%] vs. 32 of 43 [75%], P = .03). Associated with this, the incidence
in the combination treatment group (P = .028), but not in the vitamin E group, and the difference for group*time interaction was significant (P = .047). Alanine aminotransferase-to-platelet ratio index, an index of fibrosis, did not change. Insulin levels and HOMA-IR decreased significantly only within the combination group (P = .011 and P = .011, respectively). In conclusion, the combined low-dose spironolactone plus vitamin E regimen significantly decreased NAFLD liver fat score. Larger-scale trials are needed (...) Combined low-dose spironolactone plus vitamin E vs. vitamin E monotherapy on insulin resistance, noninvasive indices of steatosis and fibrosis and adipokine levels in nonalcoholic fatty liver disease: A randomized controlled trial The beneficial effects of mineralocorticoid receptor blockade by spironolactone have been shown in animal models of non-alcoholic fatty liver disease (NAFLD). The aim of the present 52-week randomized controlled trial was to compare the effects of low-dose
Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. Exposing the oral mucosa to antigen may stimulate immune tolerance. It is unknown whether treatment with oral insulin can induce a tolerogenic immune response in children genetically susceptible to type 1 diabetes.To assess the immune responses and adverse events associated with orally administered insulin in autoantibody-negative, genetically at-risk (...) children.The Pre-POINT study, a double-blind, placebo-controlled, dose-escalation, phase 1/2 clinical pilot study performed between 2009 and 2013 in Germany, Austria, the United States, and the United Kingdom and enrolling 25 islet autoantibody-negative children aged 2 to 7 years with a family history of type 1 diabetes and susceptible human leukocyte antigen class II genotypes. Follow-up was completed in August 2013.Children were randomized to receive oral insulin (n = 15) or placebo (n = 10) once daily
The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily DosingIntervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in people The requirement to inject current basal insulin analogs at a fixed time each day may complicate adherence and compromise glycemic control. This trial evaluated the efficacy and safety of varying the daily injection time of insulin degludec (...) (IDeg), an ultra-long-acting basal insulin.This 26-week, open-label, treat-to-target trial enrolled adults (≥18 years) with type 2 diabetes who were either insulin naïve and receiving oral antidiabetic drugs (OADs) (HbA(1c) = 7-11%) or previously on basal insulin ± OAD(s) (HbA(1c) = 7-10%). Participants were randomized to 1) once-daily (OD) IDeg in a prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n = 229); 2) once-daily IDeg at the main evening meal (IDeg
A Randomized Trial of Two Weight-Based Doses of Insulin Glargine and Glulisine in Hospitalized Subjects With Type 2 Diabetes and Renal Insufficiency Renal insufficiency may increase the risk of hypoglycemia in hospitalized patients with diabetes who are treated with insulin. We randomized inpatients with type 2 diabetes and chronic renal failure to treatment with two different dose levels of insulin glargine and glulisine and studied control of hyperglycemia and the frequency of hypoglycemia.We (...) conducted a multicenter, prospective, randomized trial to compare the efficacy of once-daily glargine and three-times daily glulisine at 0.5 vs. 0.25 units/kg/day. A total of 107 subjects had type 2 diabetes for >1 year, had a glomerular filtration rate <45 mL/min but did not require dialysis, and had an initial blood glucose (BG) >180 mg/dL. Doses were adjusted based on four-times daily BG measurements for 6 days.Mean BG on the first day was 196 ± 71 mg/dL in the group receiving 0.5 units/kg (0.5 group
Effects of a single post-partum injection of a high dose of vitamin D on glucose tolerance and insulin resistance in mothers with first-time gestational diabetes mellitus This study was performed to determine the effect of a single, large, intramuscular injection of vitamin D post-partum on glucose tolerance and insulin resistance in women with gestational diabetes.Forty-five participants in a randomized controlled trial on gestational diabetes mellitus were divided into an intervention group (...) and a control group. Only subjects in the intervention group received one intramuscular injection of 300,000 IU of vitamin D3. HbA(1c), serum 25-hydroxyvitamin D3, fasting insulin and blood glucose, C-peptide, homeostasis model assessment insulin resistance index (HOMA-IR), β-cell function, insulin sensitivity and the Quantitative Insulin Sensitivity Check Index (QUICKI) were measured at baseline and after 3 months of intervention.Approximately 80% of the mothers had a degree of vitamin D deficiency. Post
, multicenter study, adult patients (n = 180) with type 1 diabetes (>1 year), on a basal-bolus insulinregimen (>6 months), with HbA(1c) ≥ 8%, were randomized to usual quarterly follow-up (G1), home use of a smartphone recommending insulindoses with quarterly visits (G2), or use of the smartphone with short teleconsultations every 2 weeks but no visit until point end (G3).Six-month mean HbA(1c) in G3 (8.41 ± 1.04%) was lower than in G1 (9.10 ± 1.16%; P = 0.0019). G2 displayed intermediate results (8.63 (...) The Diabeo Software Enabling Individualized InsulinDose Adjustments Combined With Telemedicine Support Improves HbA1c in Poorly Controlled Type 1 Diabetic Patients: A 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study) To demonstrate that Diabeo software enabling individualized insulindose adjustments combined with telemedicine support significantly improves HbA(1c) in poorly controlled type 1 diabetic patients.In a six-month open-label parallel-group
Is a priming dose of insulin necessary in a low-doseinsulin protocol for the treatment of diabetic ketoacidosis? The purpose of this study was to assess the efficacy of an insulin priming dose with a continuous insulin infusion versus two continuous infusions without a priming dose.This prospective randomized protocol used three insulin therapy methods: 1) load group using a priming dose of 0.07 units of regular insulin per kg body weight followed by a dose of 0.07 unit x kg(-1) x h(-1) i.v (...) . in 12 patients with diabetic ketoacidosis (DKA); 2) no load group using an infusion of regular insulin of 0.07 unit . kg body weight(-1) x h(-1) without a loading dose in 12 patients with DKA, and 3) twice no load group using an infusion of regular insulin of 0.14 x kg(-1) x h(-1) without a loading dose in 13 patients with DKA. Outcome was based on the effects of insulin therapy on biochemical and hormonal changes during treatment and recovery of DKA.The load group reached a peak in free insulin
Improvement of glycaemia control in subjects with type 2 diabetes by self-monitoring of blood glucose: comparison of two management programs adjusting bedtime insulindosage Self-monitoring of blood glucose (SMBG) is important for patients treated with insulin to detect asymptomatic hypoglycaemia and to guide patients towards reaching blood glucose goal. This study compared two management programs for adjusting bedtime insulindose: program 1 (performed by study subjects) vs. program 2 (...) ' reminder) and reviewed by the investigators at a 4-week interval clinical visit.The mean SMBG decreased significantly in both groups, with a greater decrease observed in program 2 vs. program 1 (from 198.7 +/- 43.1 to 122.6 +/- 21.9 mg/dl vs. from 194.0 +/- 42.7 to 151.6 +/- 37.7 mg/dl, p < 0.001). Bedtime insulindose increased in both groups with a greater increase in program 2 (from 14.4 +/- 8.7 to 27.4 +/- 12.8 IU vs. from 14.3 +/- 8.3 to 18.4 +/- 6.2 IU, p < 0.001). There was a significant
Summary for patients. Splitting the evening insulindose to avoid low blood sugar levels and to improve sugar control in patients with type 1 diabetes. 11926807 2002 04 23 2016 11 24 1539-3704 136 7 2002 Apr 02 Annals of internal medicine Ann. Intern. Med. Summary for patients. Splitting the evening insulindose to avoid low blood sugar levels and to improve sugar control in patients with type 1 diabetes. I29 eng Clinical Trial Journal Article Patient Education Handout Randomized Controlled (...) Trial United States Ann Intern Med 0372351 0003-4819 0 Blood Glucose 0 Hypoglycemic Agents 0 Insulin 53027-39-7 Insulin, Isophane AIM IM Ann Intern Med. 2002 Apr 2;136(7):504-14 11926785 Adult Blood Glucose metabolism Circadian Rhythm Cross-Over Studies Diabetes Mellitus, Type 1 blood drug therapy Drug Administration Schedule Female Humans Hypoglycemia prevention & control Hypoglycemic Agents administration & dosage adverse effects Insulin administration & dosage adverse effects blood Insulin
Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes.Randomised design with participants either attending training immediately (immediate DAFNE) or acting as waiting list (...) control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.
Twice daily versus four times daily insulindoseregimens for diabetes in pregnancy: randomised controlled trial. To compare perinatal outcome and glycaemic control in two groups of pregnant diabetic patients receiving two insulin regimens.Randomised controlled open label study.University affiliated hospital, Israel.138 patients with gestational diabetes mellitus and 58 patients with pregestational diabetes mellitus received insulin four times daily, and 136 patients with gestational diabetes (...) and 60 patients with pregestational diabetes received insulin twice daily.Three doses of regular insulin before meals and an intermediate insulindose before bedtime (four times daily regimen), and a combination of regular and intermediate insulin in the morning and evening (twice daily regimen).Maternal glycaemic control and perinatal outcome.Mean daily insulin concentration before birth was higher in the women receiving insulin four times daily compared with twice daily: by 22 units (95% confidence
[Medication consumption in diabetes mellitus (VI): economics and effectiveness of insulin and sulfonylurea combination therapy compared with conventional two daily doses] Consumo de medicacion en la diabetes mellitus (VI): economia y efectividad de la terapia combinada con insulina y sulfonilureas sobre la administracion convencional con dos dosis [Medication consumption in diabetes mellitus (VI): economics and effectiveness of insulin and sulfonylurea combination therapy compared (...) with conventional two daily doses] Consumo de medicacion en la diabetes mellitus (VI): economia y efectividad de la terapia combinada con insulina y sulfonilureas sobre la administracion convencional con dos dosis [Medication consumption in diabetes mellitus (VI): economics and effectiveness of insulin and sulfonylurea combination therapy compared with conventional two daily doses] Costa B, Estopa A, Borras J, Sabate A Record Status This is a critical abstract of an economic evaluation that meets the criteria
Implantable insulin pump vs multiple-doseinsulin for non-insulin-dependent diabetes mellitus: a randomized clinical trial. Department of Veterans Affairs Implantable Insulin Pump Study Group. To determine whether implantable insulin pump (IIP) therapy and multiple daily insulin (MDI) injections could equally attain improved blood glucose control, and to compare the 2 treatments with respect to reducing daily blood glucose fluctuations, reducing serious hypoglycemic insulin reactions (...) , and improving patients' quality of life.Randomized clinical trial.Seven Veterans Affairs medical centers.One hundred twenty-one male type II diabetic patients between the ages of 40 and 69 years, receiving at least 1 injection of insulin per day and having hemoglobin A1c (HbA1c) levels of 8% or above.Intensive therapy (IIP or MDI) for 1 year.Hemoglobin A1c and blood glucose levels.Blood glucose levels declined to 7.96+/-1.08 mmol/L (143.4+/-19.5 mg/dL) and 8.30+/-1.52 mmol/L (149.6+/-27.4 mg/dL) (mean