In this week’s issue of The Savvy Diabetic:
- Dexcom’s FTC Warning Letter over Deficiencies
- Double Diabetes: Silent Threat Hiding in Type 1 Patients
- Mounjaro vs. Ozempic: Which One Is Right for You?
- Sleep Duration & Timing and Impact on Glycemic Variability
- Specific Pathways to Disease-modifying Pharmacological Treatments
- diaTribe Kidney/Heart/Metabolism Webinar (video)
- Smartphones & Brain Activity Impact
- Hibiscus Health “Selfies” Detect Diabetes
- FTC on PBMs System of “Disgusting” Higher Prices
Dexcom falls after FDA’s warning letter over deficiencies at two facilities by Reuters and published on finance.yahoo.com, 7 March 2025.
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following inspections of its two key manufacturing facilities, sending its shares down nearly 7% after the bell. The warning letter identified issues in manufacturing processes and quality management system at Dexcom’s facilities in San Diego, California and Mesa, Arizona.
The company did not provide details about how many observations were made at the two sites, but said it does not “expect a material impact” from the letter to its manufacturing capacity or its sales guidance for fiscal year 2025. Dexcom said it had already submitted responses to the so-called “Form 483” (A Form 483 is a type of agency report containing “observations” that FDA inspectors “deem to be objectionable.”) and is in the process of preparing a written response.
Read more: Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Double Diabetes: The Silent Threat Hiding in Type 1 Patients by Dr. Doris Maugg for Medscape.com, 5 March 2025.
Patients with type 1 diabetes (T1D) who have risk factors such as obesity and hypertension can develop insulin resistance over time, a characteristic typically associated with type 2 diabetes (T2D). This condition, known as double diabetes, combines the characteristics of T1D and T2D.
“About a quarter of patients with T1D develop metabolic syndrome,” said Thomas Haak, MD, chief physician at the Diabetes Center Bad Mergentheim, Bad Mergentheim, Germany, and former president of the German Diabetes Society (DDG), speaking at the “Innere Medizin fachübergreifend — Diabetologie grenzenlos” congress held on February 7 and 8 in Munich, Germany. “Double diabetes exists and requires appropriate treatment,” said Haak.
Diagnosis involves assessing the clinical presentation of T1D, measuring C-peptide levels in the blood, and considering family history. Relevant clinical parameters include obesity, body mass index (BMI), waist circumference, and metabolic syndrome, particularly triglyceride levels and hypertension.
“So how do we best manage this condition?” asked Haak. A 2024 consensus report from the American Diabetes Association identified three key strategies: lifestyle changes (such as high-fiber diets), bariatric surgery, and medications. Haak emphasized that dietary adjustments are an effective method, focusing on reducing fat and carbohydrate intake. He highlighted the effectiveness of an initial 12-day “liver fast,” a protein-restricted diet that helps improve metabolic parameters. Short-term dietary interventions, such as two consecutive “oat days” during which only oats are consumed, are beneficial for insulin resistance.
Read more: Double Diabetes: The Silent Threat Hiding in Type 1 Patients
Mounjaro vs Ozempic: Which One Is Right for You? by TCOYD.org, 21 February 2025.
How are these two game-changing medications alike? How are they different? How do you know which one is right for you?
The main difference between Ozempic and Mounjaro is how each medication works in the body. Ozempic mimics the GLP-1 hormone, while Mounjaro targets both GLP-1 and GIP receptors. Scientists and researchers are currently doing studies to further understand the differences. What Do GLP-1 RAs and GIPs Do?
Read more: Mounjaro vs Ozempic: Which One Is Right for You?
Trajectories of Sleep Duration, Sleep Onset Timing, and Continuous Glucose Monitoring in Adults by Luqi Shen et al and published by JAMANetwork.com, 5 March 2025.
In this cohort study of 1156 participants aged 46 to 83, the trajectories of long-term insufficient sleep duration and persistent late sleep onset, whether alone or in combination, were associated with greater fluctuations in blood glucose levels as monitored by continuous glucose monitoring.
These findings provide important evidence supporting the health benefit of sufficient sleep duration and early sleep onset for optimizing glycemic control in adults.
In this cohort study of middle-aged and older participants, persistent inadequate sleep duration and late sleep onset, whether alone or in combination, were associated with greater glycemic variability. These findings emphasize the importance of considering both sleep duration and timing for optimizing glycemic control in the general population
Read more: Trajectories of Sleep Duration, Sleep Onset Timing, and Continuous Glucose Monitoring in Adults
Disease-modifying pharmacological treatments of type 1 diabetes, a research paper by Liudmila Kosheleva et al and published by Pharmrev.aspetjournals.org, March 2025.
After a century of extensive scientific investigations, there is still no curative or disease-modifying treatment available that can provide long-lasting remission for patients diagnosed with type 1 diabetes (T1D). Although T1D has historically been regarded as a classic autoimmune disorder targeting and destroying pancreatic islet β-cells, significant research has recently demonstrated that β-cells play a substantial role in the disease’s progression, which could explain some unfavorable clinical outcomes.
This research delves into the underlying causes of T1D and identifies critical mechanisms governing β-cell function in both healthy and diseased states. Thus, we identify specific pathways that could be manipulated by existing or new pharmacological interventions. These interventions fall into several categories: (1) immunomodifying therapies individually targeting immune cell processes, (2) interventions targeting β-cells, (3) compounds that act simultaneously on both immune cell and β-cell pathways, and (4) combinations of compounds simultaneously targeting immune and β-cell pathways.
Read the study: Disease-modifying pharmacological treatments of type 1 diabetes
diaTribe Musings: Protect Your Kidneys, Heart, and Metabolism from Complications by the diaTribe Foundation, 5 March 2025.
Cardiovascular and kidney disease are among the most significant health complications for many people with diabetes, but the good news is that we are learning more and more about how to prevent and treat these risks through regular screening and combinations of new and existing therapies. Where there was once mostly fear, there is now hope.
This Musings panel from the diaTribe Foundation is moderated by Dr. Diana Isaacs, Cleveland Clinic. Our highly-regarded speakers are: Dr. Robert A. Gabbay, Harvard Medical School and Joslin Diabetes Center; Dr. Jennifer Green, Duke University School of Medicine; Dr. Thishi Surendranathan, Boehringer Inghelheim.
Other resources:
Scientists observe that smartphone restriction for three days can alter brain activity by Sanjukta Mondal for MedicalXpress.com, 4 March 2025.
A smartphone’s glow is often the first and last thing we see as we wake up in the morning and go to sleep at the end of the day. It is increasingly becoming an extension of our body that we struggle to part with. In a recent study in Computers in Human Behavior, scientists observed that staying away from smartphones can even change one’s brain chemistry.
After the three-day restriction period, participants underwent fMRI scans while being shown different sets of images: neutral scenes (such as landscapes and boats), smartphones turned on, and smartphones turned off. The scans revealed that limiting smartphones led to brain activity changes in areas associated with dopamine and serotonin—neurotransmitters that regulate mood, emotions and also addiction. The researchers noted that smartphone restriction can resemble withdrawal from addictive substances or even food cravings in some ways, which was noticeable in both heavy (ESU) and regular smartphone (non-ESU) participants.
As technology advances, it’s crucial to recognize how our smartphone usage habits affect our brains.
Read more: Scientists observe that smartphone restriction for three days can alter brain activity
How Hibiscus Health Detects Diabetes Risk Using Selfies by StartUpHealth, 3 March 2025.
Kavi Misri, CEO & Founder of Hibiscus Health, discusses his company’s innovative use of facial scan technology to detect chronic conditions like diabetes through a simple selfie. This technology offers easier and more accessible health screenings, particularly for large employers, helping to detect conditions early and reduce healthcare costs.
Hibiscus Health uses facial blood flow analysis from selfies to identify chronic conditions like diabetes, making health screenings accessible anytime and anywhere. Employer Benefits: The technology is especially valuable for self-funded employers, helping them manage rising healthcare costs by identifying pre-diabetic employees and offering early intervention.
Does this technology concern you?
Read more: Hibiscus Health Is Combining the Latest Tech Tools to Transform Diabetes Health
FTC report on pharmacy benefit managers uncovers a system ‘addicted to higher list prices’ by Rob Volansky for Healio.com, 7 March 2025.
The “big three” pharmacy benefit managers have imposed markups ranging from 100% to more than 7,000% on generic specialty drugs dispensed at their affiliated pharmacies, according to a Federal Trade Commission report released this year. The markups — at CVS Caremark, Express Scripts, and OptumRx — were seen not only in medications to treat cancer and HIV, but also in the rheumatology space.
“The FTC really let them have it,” Robert W. Levin, MD, past president of the Florida Society of Rheumatology, president of the Alliance for Transparent and Affordable Prescriptions, and associate affiliate professor of medicine at the University of South Florida, told Healio. “The markups on these drugs are disgusting.”
“Remember, these are generic small molecule drugs like an aspirin that do not cost much to make at all,” Madelaine A. Feldman, MD, FACR, vice president of advocacy and government affairs at the Coalition of State Rheumatology Organizations, and founder and past president of the Rheumatology Alliance of Louisiana, said in an interview. “The significant markups on the generic specialty medications the FTC analyzed generated more than $7.3 billion in income from dispensing drugs over their estimated acquisition costs from 2017 to 2022,” she added. “The acquisition cost of the drugs was based on the NADAC price.” (NADAC refers to the average acquisition cost of the drug for pharmacies, according to Feldman.)
Read more: FTC report on pharmacy benefit managers uncovers a system ‘addicted to higher list prices’