Association Between T1D, Hypoglycemia, and BMI

Type 1 diabetes mellitus patients with high BMI and hypoglycemia may improve quality of life through dapagliflozin treatment.  

Type 1 diabetes mellitus is caused by the body’s action, treating its pancreatic B cells as foreign bodies and destroying them through autoimmune reactions. Therefore, type 1 diabetes mellitus patients have inadequate insulin production or are unable to produce any insulin at all. Such people require a medical intervention called insulin therapy, which helps them to balance their body glucose (GLUC) and glycated hemoglobin at safe levels. People with type 1 diabetes mellitus have an increased risk of developing acute hyperglycemia, which can progress into micro and macrovascular diseases such as nephropathy and coronary artery disease (CAD), respectively. The ability to control the body‘s glucose levels has been associated with better health, with the risk of several of these complications reduced significantly. However, glycemic control has been known to, on occasion, slip into hypoglycemia. This study was done to show the association between BMI, hypoglycemia, and life quality. It also determines the effect of dapagliflozin, a medication, on patients with type 1 diabetes mellitus by assessing self-reported patient satisfaction levels.   

The data used was from the DEPICT clinical program. DEPICT program was divided into two centers: DEPICT1 and DEPICT2. Both of the centers employed placebo-controlled, randomized, and double–blind research techniques for selecting participants. The study included an 8-week assessment and optimization of glycemic control in type 1 diabetes mellitus patients, followed by 24 weeks of double–blind short and 28 weeks of long double-blind treatment periods—lastly, four weeks of follow–up. Participants were aged between 18-75 years and were required to have insufficient glycemic regulation in at least a year of continuous insulin therapy. People with insulin dosages more significant than 0.3 IU/kg/day ongoing for three or more months were also included in the study. Participants with glycated hemoglobin of 58.5-91.3 mmol/mol and a BMI higher than 18.5kg/m2 were randomly picked. The participants were given 5mg of dapagliflozin, 10mg of dapagliflozin, or a placebo once daily in a randomized fashion.  

The study was focused on glycated hemoglobin levels, hypoglycemic episodes, hypoglycemic fear score (HFS), which was measured using a worry subscale28, where an overall rating of 72 was considered to indicate greater hypoglycemic fear, HRQol, and satisfaction of treatment which was measured using the DTSQ total score31. The scale was 0-36. Higher values show the patients were satisfied with the insulin treatment.  

Six hundred sixty-five patients participated in the HFS analysis, with a portion of them included in an EQ-5D model. HFS increased significantly in association with acute hypoglycemia (P=0.004) and increased symptomatic episodes (P=0.026). At baseline, the age factor was associated with reduced HFs (P=0.011). Patients with increased BMI and high HFS were found to have reduced EQ-5D. Reduced glycated hemoglobin and hypoglycemic episodes were not associated with patients with dapagliflozin treatment. Patients with dapagliflozin treatment scored more than 3 points in the DTSQ. The study results also showed that dapagliflozin treatment did not affect hypoglycemia, even with low glycate hemoglobin levels. It was, however, associated with improved treatment satisfaction. This medication inhibits SLGT-2, effectively promoting glucose excretion in urine. Results showed that dapagliflozin contributed to a low BMI and significantly better glycemic regulation, notably low hypoglycemic risk.  

The study was rich in datasets that were obtained from the DEPICT program. The data in this study only shows the situation in a clinical setting. Applying the conclusions in real-world problems should be done with extreme caution. Although the study was poised to look at the quality of life for type 1 diabetes mellitus patients, there was insufficient data to make any inferences. The majority of previous studies on the topic have combined type 1 diabetes mellitus patients and type 2 diabetes mellitus patients.  

Practice Pearls:  

• Type 1 diabetes mellitus patients with high BMI and hypoglycemic episodes have low HRQoL.  
• Dapagliflozin lowers glycated hemoglobin in patients with type 1 diabetes mellitus  
• Dapagliflozin reduces the risk of developing hypoglycemic episodes and improves treatment satisfaction.  

Gordon, J., Beresford-Hulme, L., Bennett, H., Tank, A., Edmonds, C., McEwan, P. “The relationship between hypoglycemia, body mass index and quality of life among patients with type 1 diabetes: observations from the DEPICT clinical trial programme.“  https://doi:10.1111/dom.13972  

Sandra Zaki, PharmD Candidate, Florida A&M University