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CGM Treatment for T2DM basal insulin. RCT. JAMA

Glucose monitors may help diabetes patients control blood suger, reduce emergency visits

Glucose monitors help diabetes patients control blood glucose.

Continuous glucose monitors can improve blood sugar control and reduce visits to the emergency room for hypoglycemia in patients with insulin-treated Type 2 diabetes, according to a study published Wednesday in JAMA.

The Kaiser Permanente study found that continual monitoring, which is the standard care for patients with Type 1 diabetes, can also help patients with Type 2 diabetes.

”The improvement in blood sugar control was comparable to what a patient might experience after starting a new diabetes medication,” study lead author Andrew J. Karter, a senior research scientist with the Kaiser Permanente Northern California Division of Research, said in a press release.

The comparative study included 5,673 patients with Type 1 diabetes and 36,080 patients with Type 2 diabetes treated with insulin who were self-monitoring their blood glucose levels.

Using techniques mimicking randomization in a clinical trial, the researchers evaluated before-and-after results among patients who used continuous glucose monitors compared to those who didn’t.

They found that continuous glucose monitors helped with declines in levels of HbA1c, a laboratory test used in diagnosis and treatment of diabetes that measures blood sugar levels.

”Blood sugar levels that go too low can be dangerous,” said study senior author Dr. Richard Dlott, an endocrinologist and the medical director of population care for The Permanente Medical Group.

Read the abstract and full article in pdf free

https://jamanetwork.com/journals/jama/fullarticle/2780593

Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin A Randomized Clinical Trial

Author Affiliations Article Information

JAMA. 2021;325(22):2262-2272. doi:10.1001/jama.2021.7444

Key Points

Question  For adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin in primary care practices, does continuous glucose monitoring improve hemoglobin A1c (HbA1c) levels compared with blood glucose meter monitoring?

Findings  In a randomized clinical trial including 175 adults with type 2 diabetes, there was a significantly greater decrease in HbA1c level over 8 months with continuous glucose monitoring than with blood glucose meter monitoring (−1.1% vs −0.6%).

Meaning  Continuous glucose monitoring resulted in better glycemic control compared with blood glucose meter monitoring in adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin.

Abstract

Importance  Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.

Objective  To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.

Design, Setting, and Participants  This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.

Interventions  Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).

Main Outcomes and Measures  The primary outcome was hemoglobin A1c(HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.

Results  Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, −0.4% [95% CI, −0.8% to −0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, −16% [95% CI, −21% to −11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, −26 mg/dL [95% CI, −41 to −12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.

Conclusions and Relevance  Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.

Trial Registration  ClinicalTrials.gov Identifier: NCT03566693

 

From the article
Introduction

A study based on National Health and Nutrition Examination Survey (NHANES) data between 2005 and 2012 estimated that approximately 30% of US residents with type 2 diabetes were treated with insulin, with about two-thirds using basal insulin without prandial insulin. Yet only 62% of individuals using insulin were estimated to have achieved a hemoglobin A1c (HbA1c) level of less than 8.0% and only 31% achieved a level of less than 7.0%.1 More recent evaluation of NHANES data suggests there had not been any improvement in diabetes glycemic outcomes in the US between 2005 and 2016.2

Glucose monitoring is central to safe and effective management for individuals with type 2 diabetes using insulin. Glucose management based on blood glucose meter (BGM) testing for individuals with type 2 diabetes using insulin has been demonstrated to be effective in treat-to-target trials3 and in observational studies,4 but other studies have documented that self-monitoring of blood glucose with self-titration of insulin was underutilized in routine practice.5,6

Real-time continuous glucose monitoring (CGM), by providing glucose measurements as often as every 5 minutes, low and high glucose alerts, and glucose trend information, has the potential to better inform diabetes management decisions compared with episodic self-monitoring with a BGM. Studies have demonstrated that CGM improved glycemic control in individuals with type 1 diabetes712 and with type 2 diabetes using insulin regimens with basal plus prandial insulin.13 The role of CGM in individuals with type 2 diabetes using less-intensive insulin regimens is not well defined. To evaluate the effectiveness of CGM in these patients, an 8-month randomized, multicenter, clinical trial was conducted comparing CGM vs BGM monitoring in patients with type 2 diabetes treated with basal insulin without prandial insulin whose diabetes was being managed by primary care clinicians.

Discussion

In this randomized trial of patients with type 2 diabetes and poor glycemic control (mean HbA1c level, 9.1%) treated with basal insulin without prandial insulin and recruited from a primary care setting, HbA1c level improvement at 8 months was significantly greater in participants using CGM than in participants using a BGM alone for glucose monitoring. The greater HbA1c level improvement was reflected in an increase in CGM-measured time in the target glucose range of 70 to 180 mg/dL and a reduction in both time spent at greater than 250 mg/dL and mean glucose level.

Exploratory subgroup analyses based on baseline participant characteristics suggested that a HbA1c level difference favoring the CGM group was present across the age range of 33 to 79 years and the baseline HbA1c range of 7.1% to 11.6%, for all education levels, and in those with higher and lower diabetes numeracy. HbA1c level improvement was achieved while reducing the frequency of CGM-measured hypoglycemia.

The high rate of persistent CGM use over 8 months and the high scores on the CGM satisfaction scale are similar to the findings of a randomized trial evaluating CGM in patients with type 2 diabetes using basal insulin plus prandial insulin.13To our knowledge, there has not been a prior randomized trial that has evaluated CGM in patients with type 2 diabetes using basal but not prandial insulin.

The strengths of this study included a racially and socioeconomically diverse study population, with most participants being non-White, with less than a college degree, and without private insurance. The study assessed the benefit of CGM vs optimized care for the BGM group, which was reflected in improvement in HbA1c level in the BGM group. Because type 2 diabetes is primarily managed in the primary care setting and not by endocrinologists, the study was designed to recruit patients from primary care practices. However, the involvement of the diabetes specialists in this study as advisors to primary care clinicians is not currently standard practice in many clinical settings and thus limits the generalizability of the study findings.

 
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