Monthly Archives: June 2022

Another interesting development is how Ive started connecting the subtlest initial physical sensations of impending low or high sugar to my readings. Those earliest symptoms (like feeling a teeny bit faint or having a quickened heartbeat with low blood sugar, and a slight tinge of nausea or dehydration with high blood sugar) can mimic some of the effects of exercising, so its trickier for me to discern what is blood sugar-related or not during a workout. Checking that real-time data point against how my body is feeling more frequently has been helpful for learning more about what these sensations are indicating.

While I mostly exercise at home, Ive also used the Venu 2S while hiking in the mountains or at fitness studios in the city. It makes checking my blood sugar less of a hassle and more subtleI can do it while in downward dog or on a Pilates reformer, for instance.

Before the Garmin, Id generally leave my phone in my bag during classes and look at my blood sugar on my pump. While I usually give the instructor a heads up that my insulin pump may beep during class, I still get side-eye from people (who perhaps think Im checking my phone), and sometimes the instructor forgets and says something too. Thats not on meand no one should ever feel like they should conceal their medical technologybut I do like having a more discreet option thats there if I want it.

My biggest surprise is how the Dexcom-Garmin integration has become a useful component of my diabetes care outside of working out too. There are so many times during the day when glancing down at my wrist is simply more quick and seamless than consulting my phone or insulin pump. (Wearing my Garmin nearly around the clock is easy given the impressive battery lifeas someone with a habit of letting my devices die, I love that a full charge lasts a good four to five days.)

Ive found the watch useful while driving, walking, showering, booking it through the airport, and even getting a massage. Its also been clutch in certain social situationswhile out to dinner with a friend, at a movie, or on a date, for instance. (My phone is often in my bag and my pump tucked in my back pocket or bra, making it a little awkward to fish out.). Plus, I like not having to take out my phone mid-conversation.

Something else I appreciate is how the customizability of the Venu 2S lets me take what I need from a smartwatch and leave the rest behind. I can turn off a lot of the notifications that feel excessive and pare down the data visible on the screens so Im not overwhelmed by metrics. Ive only scratched the surface of this watchs tracking capabilities, but the reality is that Im already required to quantify and monitor so much when it comes to my health for the sake of diabetes management, that adding more of that to the mix is just not a priority.

Outside of the CGM functionality, I really like this watch as a general fitness tracker. The touch screen, side buttons, and accompanying app are all simple and intuitive to use. While I havent utilized some of the Venu 2Ss more advanced fitness tracking capabilities, I still find the most basic metrics valuable. I love seeing my heart rate get up there when Im really pushing myself, as well as my heart rate range breakdown after my workoutit enhances my sense of accomplishment more than I thought a number would. Im a big walker, so I like the step count function too. And the distance tracker was helpful while hiking.

See the article here:
I Have Diabetes, and This Garmin Dexcom G6 Integration Is the Fitness Tracker Integration for Me - Self

Mounjaro led to significantly greater fat mass reductions compared to placebo and to injectable semaglutide 1 mg in adults with type 2 diabetes in mechanism of action study

Exploratory analysis showed that Mounjaro achieved A1C and weight targets in less time than injectable semaglutide 1 mg or titrated insulin degludec

INDIANAPOLIS, June 6, 2022 /PRNewswire/ -- New data from a mechanism of action study and new analyses of the global registration program for Eli Lilly and Company's (NYSE: LLY) Mounjaro (tirzepatide) injection were presented at the American Diabetes Association's (ADA) 82nd Scientific Sessions, adding to the robust body of data about Mounjaro for the treatment of adults with type 2 diabetes. More than 20 presentations on Mounjaro were accepted for disclosure at the ADA's Scientific Sessions.

"Lilly is proud to present new mechanism of action data and new analyses of the results that Mounjaro delivered throughout the SURPASS program at the ADA's Scientific Sessions, helping us further evaluate how Mounjaro canhelp adults living with type 2 diabetes manage key aspects of their disease," said Laura Fernndez Land, MD, associate vice president, Medical, Lilly Diabetes. "Exploring factors such as how quickly Mounjaro can help lower A1C and weight, or the relationship between those two measures throughout the SURPASS program, is important as we begin to bring Mounjaro to people living with type 2 diabetes."

Mounjaro Mechanism of Action Study Additional results of a phase 1 mechanism of action study were presented in an oral presentation on Monday, June 6 during the "Incretin Based Therapies" session. This study was a 28-week,randomized, double-blind, parallel study to evaluate the effect of Mounjaro 15 mg compared to placebo and to injectable semaglutide 1 mg. The primary endpoint, previously disclosed, compared the effect of Mounjaro 15 mg versus placebo on total clamp disposition index at 28 weeks. The secondary objectives presented today at ADA compared the effects of Mounjaro 15 mg to placebo and to injectable semaglutide 1 mg on energy intake, appetite and body composition in adults with type 2 diabetes as measured by change from baseline.

At 28 weeks, participants taking Mounjaro (N=45) had significantly greater reductions in weight and in fat mass compared to those taking injectable semaglutide 1 mg (N=44) and placebo (N=28):

Further, treatment with Mounjaro 15 mg and injectable semaglutide 1 mgresulted insignificant reductions from baseline in energy intake (-348.4 kcal and -284.1 kcal, respectively, p=0.187) as well as reductions in appetite ratings.

Relationship Between Body Weight Change and Glycemic Control with MounjaroResults from this post-hoc analysis of all five studies within the SURPASS global registration program were presented in a poster session. This analysis assessed the relationship between A1C and body weight reductions with Mounjaro treatment (5 mg, 10 mg or 15 mg) across the SURPASS-1 through -5 clinical trials. Results showed that between 87% and 97% of participants taking Mounjaro experienced both A1C and weight reductions.

Time to Reach Glycemic and Weight Targets with Tirzepatide Compared to Injectable Semaglutide 1 mg and Titrated Insulin DegludecResults from this exploratory analysis of SURPASS-2 and SURPASS-3 were shared in a poster session, evaluating the median time taken to achieve certain glycemic targets (i.e., median time to A1C <7% and 6.5%) and the median time taken to achieve at least 5% weight loss. The analysis compared the time to reach the A1C targets from baseline among participants treated with Mounjaro(5 mg, 10 mg and 15 mg) versusthose treated with injectable semaglutide 1 mg(SURPASS-2) or those treated with titrated insulin degludec (SURPASS-3), and the time to reach the weight target among participants treated with Mounjaro or injectable semaglutide 1 mg. Participants takingall three doses ofMounjaroreached these A1C targets about four weeks sooner than those taking injectable semaglutide 1 mg, and between four weeks and 12 weeks sooner than those taking titrated insulin degludec.

Specifically, results showed:

About Mounjaro (tirzepatide) injectionMounjaro (tirzepatide) injection is FDA-approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). Mounjaro is available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and comes in Lilly's well-established auto-injector pen with a pre-attached, hidden needle that patients do not need to handle or see.

Limitations of Use:

Important Safety Information for Mounjaro (tirzepatide)

WARNING: RISK OF THYROID C-CELL TUMORS

In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Mounjaro causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro.

Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro.

Risk of Thyroid C-cell Tumors:Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Pancreatitis:Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has been reported in Mounjaro clinical trials. Mounjaro has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on Mounjaro. Observe patients for signs and symptoms, including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Mounjaro and initiate appropriate management.

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin:Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

Hypersensitivity Reactions:Hypersensitivity reactions, sometimes severe, have been reported with Mounjaro in clinical trials. If hypersensitivity reactions occur, discontinue use of Mounjaro; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity to Mounjaro. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Mounjaro.

Acute Kidney Injury:Mounjaro has been associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhea. These events may lead to dehydration, which if severe could cause acute kidney injury. In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis. Some of these events have been reported in patients without known underlying renal disease.A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Mounjaro in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Severe Gastrointestinal Disease:Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy:Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Mounjaro has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Acute Gallbladder Disease:In clinical trials, acute gallbladder disease was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

The most common adverse reactionsreported in 5% of Mounjaro-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.

Drug Interactions:When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.

Pregnancy:Limited data on Mounjaro use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation:There are no data on the presence of tirzepatide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mounjaro and any potential adverse effects on the breastfed infant from Mounjaro or from the underlying maternal condition.

Females of Reproductive Potential:Advise females using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.

Pediatric Use:Safety and effectiveness of Mounjaro have not been established and use is not recommended in patients less than 18 years of age.

Please click to accessPrescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, andMedication Guide.Please seeInstructions for Useincluded with the pen.

TR HCP ISI MAY2022

About LillyLilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visitLilly.comandLilly.com/newsroomor follow us onFacebook,Instagram,Twitterand LinkedIn. P-LLY

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Mounjaro (tirzepatide) injection for the treatment of adults with type 2 diabetes and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Mounjaro will receive additional regulatory approvals, or that Mounjaro will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1Pedersen, SD, et al. Relationship between body weight change and glycemic control with tirzepatide treatment in people with type 2 diabetes. Abstract 729-P. Presented at the American Diabetes Association's (ADA) 82nd Scientific Sessions; June 37, 2022.2Pantalone, K, et al. Patients with Type 2 Diabetes Reach Glycemic Targets Faster with Tirzepatide Compared to Semaglutide and Titrated Insulin Degludec. Abstract 732-P. Presented at the American Diabetes Association's (ADA) 82nd Scientific Sessions; June 37, 2022.3Heise, T, et al. Tirzepatide reduces appetite, energy intake and fat mass in people with T2D. Abstract 338-OR. Presented at the American Diabetes Association's (ADA) 82nd Scientific Sessions; June 37, 2022.4 Mounjaro (tirzepatide) injection Prescribing Information. Eli Lilly & Company; May 2022.

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New analyses of Mounjaro (tirzepatide) injection for the treatment of adults with type 2 diabetes presented at the American Diabetes Association's...

Testosterone replacement therapy improved sexual symptoms, libido, symptom severity, delayed verbal recall and overall quality of life among people with poorly controlled type 2 diabetes and hypogonadism, according to research being presented Monday at ENDO 2022, the Endocrine Societys annual meeting in Atlanta, Ga.

This is the first randomized controlled trial to show significant improvements from testosterone replacement therapy, according to lead author, Preethi Mohan Rao, M.B.B.S., M.R.C.P., C.C.S.T., M.D., and Prof. Hugh Jones, consultants in diabetes and endocrinology at the Barnsley Hospital NHS Foundation Trust in Barnsley, U.K., and University of Sheffield in Sheffield, U.K.

The findings are welcome news to men with diabetes and hypogonadism, since they often have a poor quality of life, Rao said.

Rao and colleagues conducted a randomized, double-blind, placebo-controlled add-on trial of intramuscular testosterone undecanoate (Nebido, TRT) administered every 12 weeks in 65 men (mean age 59 years) with poorly-controlled diabetes and hypogonadism. In Phase 1, patients were randomly assigned to either treatment or placebo for 6 months of TRT. Phase 2 consisted of an open-label format for 6 months and those administered placebos were moved into the treatment group. Patients in the treatment group continued treatment.

In Phase 1, the mean total Aging Male Symptoms (AMS) score, which is a quality of life assessment tool in men, significantly decreased from a baseline of 48.3413.13 to 37.7212.25 at 6 months after TRT compared with placebo (p<0.05). Those who were administered TRT were more likely to move on from severe symptoms to low, mild, or moderate symptoms compared to those in the placebo group (46% vs. 28%, p=0.0024). However, there were no significant findings from SF-36 scores, MMSE scores, BDHQ, NERI or IIEF-5 scores or its domains at baseline and after 6 months of TRT.

In Phase 2, the AMS total score (p=001) and all its subscales (physical p=0.01), psychological (p=0.026), and sexual (p<0.001), with improvement in libido (p<0.001) showed significant improvements. Sexual wellbeing (p=0.002) and emotional wellbeing (p=0.011) were also significantly improved (p=0.07). In addition, QoL scores revealed better physical health (p=0.019) and health change (p=0.019). Statistically significant changes were noted for delayed verbal recall (an early sign of dementia) in this phase, as well (p=0.0004).

These findings will also form the evidence basis for our general practitioners and endocrinologists to proactively ask their diabetes patients about the symptoms at their regular health visits and investigate and diagnose hypogonadism appropriately and treat them with testosterone where indicated, Rao said. Our trial showed that the treatment is very safe when accurately monitored.

# # #

Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at http://www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.

Journal of the Endocrine Society

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Testosterone improves quality of life, sexual function, and delayed verbal recall in men with uncontrolled type 2 diabetes - EurekAlert

AN "outgoing"chef and much-loved son from Oldham died as result of his diabetes an inquest has heard.

Ashley Brooke, 33, died at his home on December 12, 2021, from diabetic ketoacidosis, a condition caused by a lack of insulin in the body.

The court heard that Ashley was diagnosed with type 1 diabetes when he was 23 and had a history of chronic drug use.

Ashley was found unresponsive at his home on the morning of Saturday, December 12, by his father Nigel Brooke and was pronounced dead by paramedics shortly afterwards.

Remembering his son Ashley, Nigel said: He was outgoing and had a lot of friends and a big social circle.

The coroner Julie Mitchell added that she could see from her notes on Ashley that he worked really hard to train as a chef and enjoyed his career.

Nigel said he became aware Ashley was taking drugs before he got his diabetes diagnosis, but it was not common knowledge, and Ashley was very private about his drug use.

He added that Ashley later confided in him that he was taking heroin which he said came as a huge shock.

As part of his treatment for drug use Ashley attended a service at The Gateway in Oldham and later Turning Point, where he was being treated at the time of his death.

Discussing Ashleys drug use, Nigel said it was always a worry and that when it became clear he wasnt getting better he paid for Ashley to attend a private detox centre.

While at the detox centre Ashley began to go through withdrawal and ended up in hospital. It was an incident that really scared him, according to his father.

Referring to the detox centre, Nigel said: Type 1 diabetes and withdrawing from heroine is an absolute nightmare situation and I dont think they could handle it that well.

Nigel added that Ashley engaged sporadically with the treatment he was offered and that he suffered with anxiety and would sometimes become anxious about going out, even just to Tesco, depending on his state of mind.

When he saw me, he seemed to brighten and be happy and okay but whether he put that on for his dad I dont know, Nigel added.

In August 2021, Ashleys paternal grandmother, who he had lived with since his teenage years, died.

Nigel told the court that Ashleys mother left the family home when he was just two years old, and his grandmother became a second mum to him.

He was very upset when she died. She was 94 and had carers that came in, but Ashley would cook for her.

Something changed after my mum passed away. Ashley didnt show much emotion he bottled it up.

"He used to go shopping for her and make sure she had everything she needed for the week. He wasnt eating as well after she died, Nigel added.

At around this time Ashley was working as a pub chef but struggled with the length of time standing due to his diabetes which would cause swelling and numbness in his hands and feet.

At the time of his death Ashleys previous boss was looking to reemploy him and Nigel was planning to set up a caf which Ashley could run.

The day before Ashley died Nigel went to visit him and did not see him check his insulin levels.

Ashley told him he had eaten a curry and had been sick for a few days.

He had vomitedand was restless and not sleeping. I got him some fruit, some rehydration tablets and paracetamol. Then he went to bed and fell asleep. I was going to stay the night but went home when I saw he was resting, Nigel said.

The next morning at around 10am, Nigel went to check on Ashley and could not wake him.

He called a close family friend and an ambulance.

The paramedics arrived quickly and attempted to revive Ashley, but he died a few minutes later.

Addressing Nigel, coroner Julie Mitchell said: I can see you are taunting yourself for not staying on that Saturday night, but I dont think you staying would have changed anything.

You looked after him in his final days as much as you could. You asked him to seek medical help, you fed him and watered him.

Coroner Mitchell later added: I can see this is causing you significant, grief, anguish, and turmoil.

You watched Ashley decline before your eyes for many years. You were a father trying to look out for his son and did the best you could. There is nothing more you could have done.

Toxicologist Julie Evans told the court that the postmortem examination showed there was little evidence of a drug overdose and suggested the direct cause of death wasketoacidosis.

Cocaine was found in Ashleys urine, indicating that it had not been taken recently, a low level of morphine was also found in his system, which could have been from heroine or morphine use, and other traces of drugs, including pregabalin, diazepam, paracetamol and dihydrocodeine, were at a level suggesting therapeutic use.

Ashleys glucose measurement was however excessive, indicating a lack of insulin, and his symptoms including vomiting suggested that ketoacidosis may have come on in the days before Ashleys death.

Ashleys GP, Dr Stephen Baxter, also gave evidence and told the court that Ashley had come to him with concerns about his anxiety.

He said Ashley spoke about his diabetes as an after thought when visiting him and that he did not respond to his annual diabetic reviews or Dr Baxters advice to see a diabetic nurse.

Referring to Dr Baxter as caring, coroner Mitchell concluded that there were no missed opportunities in Ashleys care or treatment and that his direct cause of death was ketoacidosis,and type 1 diabetes, fatty liver disease and drug use were contributory factors.

She saidthat his drug use was a significant contributory factor as the fact that Ashley was not testing his insulin levels regularly on Saturday, which was unusual for him, may have been due to him being under the influence of drugs.

She said: Ashleys health took a back seat when he was under the influence of drugs and that led to him suffering ketoacidosis.

The coroner recorded a narrative conclusion.

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Outgoing chef from Oldham died due to diabetes, inquest hears - The Oldham Times