Randomised controlled trial (RCT) assessed impact of two glucose monitoring systems on hypoglycaemia in people with type 1 diabetes
EDINBURGH, Scotland, Jan. 30, 2018 /PRNewswire/ -- DexCom, Inc. (Nasdaq: DXCM), announced today the publication of a novel head-to-head study that demonstrates that Dexcom G5 Mobile® Continuous Glucose Monitoring (CGM) System use reduces time spent in hypoglycaemia in people with type 1 diabetes with severe hypoglycaemia or impaired awareness of hypoglycaemia (IAH), using a multiple daily injection (MDI) regimen. In comparison, Abbott FreeStyle Libre Flash Glucose Monitoring (FGM) System use increases time spent in hypoglycaemia.
The findings of the I HART study (Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data) are published in Diabetic Medicine1, the journal of Diabetes UK. The study also concluded that Dexcom G5 Mobile CGM use reduced time spent in hypoglycaemia at night and reduced the fear of hypoglycaemia. Abbott FreeStyle Libre FGM use increased time in hypoglycaemia, including at night, and had no improvement in reducing fear of hypoglycaemia.
"This impactful study highlights the importance of innovative technologies in managing a challenging long-term condition which has serious health and psychological outcomes for young people," said Nick Oliver, Principal Investigator, Imperial College London. "It supports the role of real-time CGM devices with alerts and alarms in the clinical pathway for people with type 1 diabetes, especially those with a high risk of hypoglycaemia and impaired hypoglycaemia awareness".
The I HART study was an 8-week randomised controlled trial (RCT) including 40 adults with type 1 diabetes who have impaired hypoglycaemia awareness (as measured by a Gold score1 of ≥4) or recent severe hypoglycaemia in the past 12 months and are on a regimen of multiple daily injections (MDI) of insulin. In the study, participants were randomised into 2 groups with 20 users wearing Dexcom G5 Mobile CGM and the other 20 wearing Abbott FreeStyle Libre FGM. The key study outcomes are highlighted below.
Time Spent in Hypoglycaemia (≤ 3.3 mmol/L or 60 mg/dl)
- G5 Mobile CGM use reduced median time spent in hypoglycaemia by 43 minutes.
- Libre FGM use increased median time spent in hypoglycaemia by 19 minutes.
Time Spent in Hypoglycaemia at Night from 22:00 to 7:00 (≤ 3.3 mmol/L or 60 mg/dl)
- G5 Mobile CGM use reduced median time spent in hypoglycaemia by 24 minutes.
- Libre FGM use increased median time spent in hypoglycaemia by 9 minutes.
Reduction of Fear of Hypoglycaemia:
- G5 Mobile CGM use reduced hypoglycaemia fear, while Libre FGM use showed no improvement.
"We are delighted that the Dexcom G5 Mobile CGM System was able to demonstrate such a significant reduction in hypoglycaemia both during the day and at night, while also reducing the fear associated with hypoglycaemia," said John Lister, General Manager, Dexcom EMEA. "This study also helps to demonstrate the value of real-time CGM with alerts and alarms in helping people manage their diabetes around the clock."
Diabetes: A World-Wide Emergency
Diabetes is one of the largest global health emergencies of the 21st century. Each year more and more people live with this condition, which can result in life-changing complications. In addition to the 415 million adults who are estimated to currently have diabetes, there are 318 million adults with impaired glucose tolerance, which puts them at high risk of developing the disease in the future. According to the International Diabetes Foundation (IDF), there are 52 million people living with diabetes in Europe and by 2040, it is estimated that more than 72 million people will have the disease.2 With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. There are also around 17 million people in Europe who have diabetes but have not been diagnosed. They may be experiencing symptoms they can't explain, or they may assume that the symptoms are due to other causes, such as getting older or having a busy lifestyle. People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.3-4
About DexCom, Inc.
Founded in 1999, DexCom, Inc. has corporate offices in San Diego, California, EMEA headquarters in Edinburgh, Scotland and users in 39 countries around the world. At Dexcom, we are transforming diabetes care and management by providing superior continuous glucose monitoring (CGM) technology to help people with type 1 diabetes and healthcare professionals better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class—while empowering our community to take control of diabetes. For more information on Dexcom CGM, visit www.dexcom.com/global.
I HART Study Methodology
The I HART study is the first head-to-head glucose monitoring study and addresses the highest risk group with problematic and severe hypoglycaemia. The data contributes to the existing continuous glucose monitoring (CGM) literature and are the first for flash glucose monitoring in a high-risk group, expanding the evidence base. The results are clinically relevant and support a role for CGM in the clinical pathway in people with severe hypoglycaemia or impaired awareness of hypoglycaemia.
The randomised, non-masked parallel group study was conducted at a single specialist site in the United Kingdom, with ethical approval obtained from the NHS Research Ethics Committee. Participants aged 18 and over with type 1 diabetes for over 3 years were recruited. In addition, participants had experienced a severe hypoglycaemic event in the last 12 months requiring third party assistance or had a GOLD score of greater than or equal to 4. They had been using an intensified multiple dose insulin injection regimen for over six months and a diagnosis of type 1 diabetes was confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L.
All participants had received type 1 diabetes structured education, including the principles of flexible insulin therapy, either as group or in a one to one environment from a specialist educator. Participants were excluded if they had used CGM or FGM within the last six months (except short periods of diagnostic blinded use under clinic supervision), used regular paracetamol, were pregnant or planning pregnancy, breastfeeding, enrolled in other clinical trials, had active malignancy or were under investigation for malignancy, had severe visual impairment, or reduced manual dexterity. All participants gave written informed consent.
1The Gold score measures hypoglycaemia awareness, based on a response to "Do you know when your hypos are beginning"; 7-point scale, with 1 representing "Always Aware" and 7 "Never Aware". Score ≥ 4 indicate impaired hypoglycaemia unawareness (IAH).
2IDF Diabetes Atlas 2015.
3Hyperglycaemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated September 16, 2014. Accessed November 7, 2016.
4Hypoglycaemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 1, 2015. Accessed November 7, 2016.
SOURCE DexCom, Inc.