Effectiveness of the Low Carb Program digital intervention to instigate and sustain self-management of type 2 diabetes and prediabetes in an NHS England GP practice: service evaluation of real-world data (Preprint)

2020 ◽  
Author(s):  
Charlotte Summers ◽  
Simon Tobin ◽  
David Unwin

BACKGROUND Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. There is increasing evidence that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support behaviour change and remote self-management of long-term health conditions. OBJECTIVE Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program (LCP) digital health at a primary care NHS site, Norwood Surgery in Southport, United Kingdom. The Low Carb Program is a nutritionally focused, digitally delivered behaviour change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. METHODS We evaluated the real-world, self-reported outcomes of patients referred to the Low Carb Program by doctors at an NHS GP surgery in Southport, United Kingdom. All of the NHS patients referred to the program were diagnosed with Type 2 diabetes mellitus (T2DM) or prediabetes and given the program at no cost (N=45; mean age 54.8, SD 13.2 years; 42% (19/45) women; mean glycated hemoglobin A1c (HbA1c) 56.7 mmol/mol (range 42.1mmol/mol - 96.7mmol/mol); mean body weight 89.4 kg (SD 13.8 kg). RESULTS Of the 100 people offered the program 45 participants enrolled, all of them (100%) activated their accounts and 37 (82.2%) individuals self-reported outcomes at 12-months. Of those who enrolled 45 (100%) patients completed at least 40% of the lessons, 32 (71.1%) individuals completed >9 out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed >9 of the 12 core lessons in the program over 12-months; mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol (4.78 mmol/mol, SD 4.60), t(31)=5.87, p<0.001) and reported an average 4.17% total body weight reduction with an average reduction of 3.85kg (SD 2.35), t(31)=9.27, p<0.001) at the 12-month follow up point. CONCLUSIONS Though the data presented here has several limitations, the use of a digital app prescribed to adults with T2DM or prediabetes in a primary care setting supporting a transition to a low carbohydrate diet appears to show significant improvements in glycaemic control and weight loss. Further research to understand more about factors affecting engagement and further positive health implications would be valuable.

2021 ◽  
Vol 1 (1) ◽  
pp. 12-15
Author(s):  
Mohammed Ashfaqul Ghani ◽  
◽  
Christopher Uy ◽  
Aye Thet Hlyar Oo ◽  

Introduction: Diabetes mellitus is increasing rapidly worldwide, and treatment comes with many challenges. It is estimated that in 2030, approximately 500 million people will live with diabetes across the world—most of which will be type 2 diabetes mellitus (T2DM). Obesity often coincides with T2DM and has been linked to increased insulin resistance, high blood pressure, and high blood lipids. Thus, pharmacological management should be aimed at promoting weight loss or at very least be weight neutral. In many cases the risks of hypoglycaemia and weight gain may delay titration of diabetic agents to HbA1C targets. Both insulin and sulfonylureas are proven medications which are beneficial for tight glycemic control but with an increased risk of weight gain and hypoglycaemia. Newer agents under the drug class glucagon-like peptide receptor antagonists (GLP-1RA) are increasingly being used. Various randomized clinical trials support that obese T2DM patients treated with GLP-1RA lead to better glycaemic control, weight reduction and reduced risk of hypoglycaemia. Case Summary: A 56-year-old female was diagnosed with T2DM in 2003 and had been regularly followed up in diabetes clinic since 2014. During the initial clinic review she had a body weight of 114.9 kg (BMI 40.7), fasting blood glucose was 8 - 9, 2-hour CBG 11-13 and HbA1c of 87. At that time, she was taking insulin glargine (Lantus) 36 units once daily, gliclazide 40 mg in the morning / 120 mg in the evening, metformin slow release 2 g in the evening, and simvastatin 20 mg at bedtime. After discussion with her she was started on the GLP-1RA liraglutide subcutaneously. She had no diabetic related complication. She continued liraglutide since then. Her HbA1c started to improve and also noticed in change in body weight which had gradually decreased from 114.9 to 109 kg. Her liraglutide was held at the latter end of 2018 as her glucose control and weight had been maintained. It was noticed that after stopping liraglutide her blood glucose and weight started to go up again even though her other medications remained same. Her case was discussed at Diabetes MDT and liraglutide1.8mg restarted in September 2019 and since then she able to lose around 5% of her body weight and HBA1C also started to drop. It is noticed that since the starting of her liraglutide her HBA1C level and weight fall by around 1% and 4% respectively. In late 2018 once she stopped liraglutide her HbA1C and weight started to rise again. In 2019 liraglutide was restarted and she managed to reduce body weight by 5kg and HbA1C by 2%. During the whole time period she maintained lifestyle intervention. Discussion: Excessive fat accumulation with potential impairing effects on health know as overweight and obesity, is a major risk factor for type 2 diabetes mellitus. Most T2DM people around 80-90% fall in mild to moderate obesity or overweight need either behaviour or medication-based weight loss programme. In these patients losing as little as 5% of body weight positively affect their cardiovascular mortality and glycemic control. There is no need to mention that losing body weight and maintaining it is a challenge for the majority of diabetic patients and it is especially true for those are on oral hypoglycaemic agents such as insulin, sulfonylurea and thiazolidinediones and insulin. In that case GLP-! Receptor agonists (GLP-1 Ras) is exceptional and it is proven benefit in reducing weight in T2DM obese patients. Liraglutide is first approved in 2010 as an adjunct therapy to diet and exercise for management of type 2 diabetes. Liraglutide is a derivative of GLP-1, a polypeptide incretin hormone secreted by the L-cell of the gastrointestinal tract. It stimulates glucose dependent insulin secretion causing a decrease in plasma glucagon concentrations, delayed gastric emptying, suppress appetite and increased heart rate. It is believed that the weight lowering effect of GLP-1RA is due to appetite suppression and delayed gastric emptying. After liraglutide administration peak absorption occur at 11 hours and its absolute bioavailability is 55%. Its half-life in 13 hours, allowing it once daily administration. It eliminates through liver and kidneys and does not interfere with cytochrome p450 system. Most common side effects are nausea, hypoglycaemia, diarrhoea, constipation, abdominal pain and increased serum lipase. Gastrointestinal intolerance is the most common reason for drug discontinuation in patients. There is also an increased correlation with acute pancreatitis, serious hypoglycaemic episodes, tachycardia, and suicidal behaviour. Liraglutide is contraindicated in pregnancy and should be avoided in nursing mothers, children, and coincident use with other GLP-1 agonists. Five large scale randomized multicenter phase III trials have been conducted to evaluate the efficacy of liraglutide as a weight loss agent. Four of these are part of the Satiety and Clinical Adiposity – Liraglutide evidence in non‐diabetic and diabetic individuals (SCALE) program. During these trails, all participants were encouraged to continue their lifestyle modification. The result of the trail was satisfactory. It was found that mean weight loss was between 6% to 4.7% in comparison to placebo group (2%). A dose dependent weight loss was first observed in LEAD Trials and subsequently in SCALE programme it is confirmed. In a study in Chinese population liraglutide treatment help T2DM patient in weight reduction after 24 weeks of treatment. In long term weight reduction, the 5-year treatment with liraglutide reduce HBA1c level by almost 1%. In various study it confirmed that liraglutide has greater impact on T2DM female gender. In SCALE study it showed that 50% difference in body weight loss between man and women could be due to higher exposure to liraglutide to women. Although exposure was equal in healthy male and female subject. Reference: 1. Randomized control trials for GLP-1Ra 2. Liraglutide for weight management: A critical review of the evidence 3. A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus. 4. Long-Term Effectiveness of Liraglutide for Weight Management and Glycemic Control in Type 2 Diabetes


Author(s):  
Wahyu Sukma Samudera ◽  
Novita Fajriyah ◽  
Ida Trisnawati

Background: Type 2 diabetes mellitus was one of non-communicable diseases that increased of prevalence in word wide, included in Indonesia. Utilization of technology as an effort of increase of diabetes treatment is important for achieving of optimum glycemic control and to prevent of complication of diabetes mellitus. However, intervention for self management in patients with diabetes mellitus at this time still not using technology based mobile health intervention. Purpose: This study aims to verify of effectiveness of mobile health intervention on self management and glycemic control in patient with type 2 diabetes mellitus. Method: Design of this studies was used systematic review of randomized controlled trial with PRISMA approach. Article search was carried out through databases: Scopus, Science Direct, and ProQuest with randomized controlled trial design within last 10 years. Results: The finding showed 407 articles have been obtained. Articles selection process were through few steps: topic selection, full text selection, design of studies and obtained 10 articles have been as appropriate of inclusion criteria. Based on results of finding of 10 articles were showed that mobile health intervention was effective in improving of glycemic control by decreasing hbA1c, fasting blood glucose, 2 hours post pandrial. Furthermore, mobile health intervention was effective in increasing of self management in patient with type 2 diabetes mellitus and increased adherence of diabetes medication. Moreover, mobile health intervention can also improve of insulin level and lipid profile in patient with type 2 diabetes mellitus. Conclusion: Mobile health intervention was effective in improving of glycemic control and self management, and giving of facilitate communication between patient and health providers Keywords: mobile health application; self management; glycemic control; diabetes mellitus ABSTRAK Latar belakang: diabetes melitus (DM) tipe 2 merupakan salah satu penyakit tidak menular yang mengalami peningkatan angka kejadian di dunia, termasuk di Indonesia. Penggunaan teknologi sebagai upaya meningkatkan manajemen diabetes melitus sangatlah penting untuk dilakukan guna mencapai kontrol glikemik optimal dan mencegah komplikasi dari Diabetes Melitus. Namun, manajemen diri pada sebagian besar pasien Diabetes Melitus saat ini masih belum menggunakan bantuan teknologi berbasis mobile health. Tujuan: Penelitian ini bertujuan untuk memverifikasi efektivitas dari penggunaan mobile health intervention terhadap manajemen diri dan kontrol glikemik pasien dengan diabetes melitus tipe 2. Metode: desain dalam penelitian ini adalah systematic review dengan menggunakan pendekatan PRISMA. Pencarian artikel dilakukan pada beberapa database yang meliputi: Scopus, Science Direct dan ProQuest dengan desain Randomized controlled trial dalam 10 tahun terakhir. Hasil: hasil temuan didapatkan sejumlah 407 artikel penelitian. Proses seleksi artikel dilakukan beberapa tahap meliputi: seleksi topik, fullteks, desain artikel penelitian dan didapatkan 10 artikel penelitian yang sesuai dengan kriteria inklusi. Berdasarkan hasil temuan dari 10 artikel penelitian yang digunakan, menunjukkan bahwa mobile health intervention efektif dalam memperbaiki kontrol glikemik pasien diabetes melalui penurunan kadar hbA1c, gula darah puasa, 2 jam post pandrial. Selanjutnya, mobile health intervention efektif dalam meningkatkan manajemen diri pasien diabetes dan meningkatkan kepatuhan pengobatan. Selain itu, mobile health intervention juga dapat memperbaiki level insulin dan profil lipid pasien diabetes melitus tipe 2. Kesimpulan: Mobile health intervention efektif dalam memperbaiki kontrol glikemik dan meningkatkan manajemen diri pasien diabetes melitus serta memudahkan komunikasi antara pasien dengan tenaga kesehatan Kata kunci: mobile health application; manajemen diri; kontrol glikemik; diabetes melitus


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A331-A331
Author(s):  
Matthew J Budoff ◽  
Timothy M E Davis ◽  
Alexandra G Palmer ◽  
Robert Frederich ◽  
David E Lawrence ◽  
...  

Abstract Introduction: Ertugliflozin (ERTU), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM). Aim: As a pre-specified sub-study of the Phase 3 VERTIS CV trial (NCT01986881), the efficacy and safety of ERTU were assessed in patients with T2DM and established atherosclerotic cardiovascular disease (ASCVD) inadequately controlled with metformin and sulfonylurea (SU). Methods: Patients with T2DM, established ASCVD, and HbA1c 7.0–10.5% on stable metformin (≥1500 mg/day) and SU doses as defined per protocol were randomized to once-daily ERTU (5 mg or 15 mg) or placebo. The primary sub-study objectives were to assess the effect of ERTU on HbA1c compared with placebo and to evaluate safety and tolerability during 18-week follow-up. Key secondary endpoints included proportion of patients achieving HbA1c &lt;7%, fasting plasma glucose (FPG), body weight, and systolic blood pressure. Changes from baseline at Week 18 for continuous efficacy endpoints were assessed using a constrained longitudinal data analysis model. Results: Of the 8246 patients enrolled in the VERTIS CV trial, 330 patients were eligible for this sub-study (ERTU 5 mg, n=100; ERTU 15 mg, n=113; placebo, n=117). Patients had a mean (SD) age of 63.2 (8.4) years, T2DM duration 11.4 (7.4) years, estimated glomerular filtration rate 83.5 (17.8) mL/min/1.73 m2, and HbA1c 8.3% (1.0) (67.4 [10.6] mmol/mol). At Week 18, ERTU 5 mg and 15 mg were each associated with a significantly greater least squares mean (95% CI) HbA1c reduction from baseline versus placebo; the placebo-adjusted differences for ERTU 5 mg and 15 mg were –0.7% (–0.9, –0.4) and –0.8% (–1.0, –0.5), respectively (P&lt;0.001). A higher proportion of patients in each ERTU group achieved HbA1c &lt;7% relative to placebo (P&lt;0.001). ERTU significantly reduced FPG and body weight (P&lt;0.001, for each dose versus placebo), but not systolic blood pressure. Adverse events were reported in 48.0%, 54.9%, and 47.0% of patients in the ERTU 5 mg, 15 mg, and placebo groups, respectively. Genital mycotic infections were experienced by significantly higher proportions of male patients who received ERTU 5 mg and 15 mg (4.2% and 4.8%, respectively) versus placebo (0.0%; P≤0.05) and by a numerically, but not significantly, higher proportion of female patients who received ERTU 15 mg (10.3%) compared with placebo (3.8%) (P=0.36). The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% (15 mg), and 0.9% (placebo). Conclusion: Among patients with T2DM and ASCVD, ERTU (5 mg and 15 mg) added to metformin and SU for 18 weeks improved glycemic control (HbA1c and FPG) and reduced body weight, and was generally well tolerated with a safety profile consistent with the SGLT2 inhibitor class.


PLoS ONE ◽  
2019 ◽  
Vol 14 (10) ◽  
pp. e0223383
Author(s):  
Sharifah Saffinas Syed Soffian ◽  
Shahrul Bariyah Ahmad ◽  
Huan-Keat Chan ◽  
Shahrul Aiman Soelar ◽  
Muhammad Radzi Abu Hassan ◽  
...  

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Wagner Martorina ◽  
Almir Tavares

Aims. Sleep duration (SD) has been associated with metabolic outcomes. Is there an independent association between short/long SD and glycemic control (GC) in type 2 diabetes mellitus (T2DM) outpatients, compared to intermediate SD? Employing up-to-date definitions of SD, we comprehensively considered, simultaneously, all known confounding/mediating factors that recently emerged in the literature: age, gender, diet, physical activity, obesity, night pain, nocturnal diuresis, sleep quality, chronotype, sleep apnea, depressive symptoms, alcohol, caffeine, tobacco, number of endocrinologist appointments, T2DM family history, and sleep medication. Methods. A cross-sectional study of 140 consecutive T2DM outpatients, ages 40-65, glycohemoglobin HbA1c goal≤7. We searched for variables (including HbA1c) significantly associated with short (<6 hours) or long (>8 hours) SD, in comparison to intermediate SD (6-8 hours). Results. Higher HbA1c levels increased the chance of belonging to the group that sleeps <6 hours (p≤0.001). Better sleep quality, nocturnal diuresis, and morningness increased the chance of belonging to the group that sleeps >8 hours (p<0.05). Conclusions. There is an independent association between short SD and elevated HbA1c, in real-world T2DM outpatients. Future interventional studies could evaluate weather consistent, long-term sleep extension, from <6 hours to 7–9 hours per 24 hours, improves GC in T2DM outpatients.


2013 ◽  
Vol 59 (5) ◽  
pp. 25-31
Author(s):  
I V Glinkina

The present study included patients presenting with type 2 diabetes mellitus (DM2) of less than 10 years in duration having the HbA1c levels between 7.0% and 10.0%. They were treated with insulin detemir (once or twice daily) in combination with oral hypoglycemic agents (OHGA) and transferred thereafter to therapy with insulin glargine (Lantus, SoloSTAR) administered once daily. The patients were advised to adjust the dose of insulin glargine in order to achieve the desired fasting blood glucose level (FBGL) below 5.6 mmol/l. The HbA1c levels and FBGL, insulin doses, body weight, frequency of hypoglycemic episodes and adverse reactions were measured within 3 and 6 months after inclusion in the study; simultaneously, the patients and doctors' satisfaction with the treatment was estimated. A total of 915 patients were available for the examination (mean age 57.9±9.2 years, mean duration of DM2 5.9±2.3 years, average BMI 31.0±5.1 kg/m2). The number of the patients presenting with the HbA1c levels below 7% within 6 months after the onset of therapy amounted to 46.5% of the total. During the same period, percentage of the patients experiencing nocturnal and daytime glycemic episodes decreased. No cases of severe hypoglycemia were documented. Moreover, the body weight of the patients somewhat decreased (by 0.9±2.9 kg; p<0.001) by the 6 month. The majority of the patients and their doctors reported the effects of described therapy as "good" or "very good". It is concluded that the substitution of the treatment with insulin detemir in combination with OHGA by therapy with insulin glargine in the patients with DM2 and suboptimal glycemic control under conditions of the routine clinical practice may improve the quality of glycemic control without a substantial body weight gain and with the low frequency of hypoglycemic episodes.


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