Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes

Haak, Thomas; Hanaire, H.; Ajjan, Ramzi; Hermanns, Norbert; Riveline, Jean‐Pierre; Rayman, Gerry

doi:10.1007/s13300-017-0255-6

Cited by 171 publications

(175 citation statements)

References 20 publications

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“…Despite a reduction in hypoglycemia with flash CGM in both T1D and T2D, A1C did not increase in either study. 12,13 In T1D, there was no significant adjusted mean change in A1C from baseline with flash CGM (adjusted mean difference in A1C between flash CGM and SMBG ± SE: 0.00 ± 0.06%; p=0.96). 12 In T2D, a reduction in A1C was reported in the flash CGM group (-0.29 ± 0.07%) and in the control group (-0.31 ± 0.09%; adjusted mean difference in A1C between flash CGM and SMBG ± SE: 0.03 ± 0.11%; p=0.82).…”

Section: Clinical Implications Of Flash Continuous Glucose Monitoringmentioning

confidence: 92%

“…12,13 The objective of this review is to summarize recent data from these randomized controlled trials which assessed the efficacy and safety of flash CGM to replace routine SMBG in diabetes management.…”

Section: Traditional Continuous Glucose Monitoringmentioning

confidence: 99%

“…13 These trials IMPACT randomized 241 adults aged ≥18 years with T1D for ≥5 years, who had been on their current insulin regimen for ≥3 months prior to study entry, had a screening for A1C ≤7.5% (58 mmol/mol), and had reported blood glucose readings on a regular basis equivalent to ≥3-times daily for ≥2 months prior to study entry. 12 REPLACE randomized 224 adults aged ≥18 years with T2D treated with intensive insulin therapy, A1C 7.5-12.0%…”

Section: Recent Clinical Trials Of Flash Continuous Glucose Monitorinmentioning

confidence: 99%

“…13 For safety reasons, individuals judged to have ongoing, clinically significant hypoglycemia unawareness were excluded from either study.…”

Section: Recent Clinical Trials Of Flash Continuous Glucose Monitorinmentioning

confidence: 99%

“…12 In T2D, management aimed to avoid hypoglycemia, optimize fasting glucose, and reduce postprandial glucose excursions. 13 At 3 and 6 months in IMPACT, and at 6 months in REPLACE, individuals in the control group wore masked sensors for reassessment of glycemic parameters. A key limitation of the study design of IMPACT was that patients with quite well-controlled T1D (with A1C below 7.5% [59 mmol/mol]) were included since such patients are theoretically at higher risk of hypoglycemia 14 …”

Section: Recent Clinical Trials Of Flash Continuous Glucose Monitorinmentioning

confidence: 99%

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Flash Continuous Glucose Monitoring and its IMPACT to REPLACE Blood Glucose Monitoring in the Management of Type 1 and Type 2 Diabetes

Twigg¹,

Kazemi²,

Craig³

2017

US Endocrinology

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O bjective: Established methods of self-monitoring of glucose levels include capillary self-monitoring of blood glucose (SMBG) and interstitial continuous glucose monitoring (CGM). Flash CGM is a novel form of self-monitoring that provides on-demand continuous interstitial glucose profiles. The purpose of this article is to critically review the recent outcome data from randomized controlled trials that assessed the efficacy and safety of flash CGM to replace routine SMBG in diabetes management. Methods: Two recent six-month, prospective, multicenter, randomized controlled trials in type 1 (IMPACT; NCT02232698) and type 2 (REPLACE; NCT02082184) diabetes compared flash CGM with SMBG under otherwise usual care conditions. The trials did not use a prescribed treatment algorithm based on self-monitoring of glucose. Results: Both trials demonstrated that the time spent in hypoglycemia over a 24-hour period, as well as overnight, was markedly reduced by flash CGM without deterioration in glycated hemoglobin (A1C) levels. In IMPACT there was a 38% reduction in time in hypoglycemia with flash CGM versus SMBG, and in REPLACE there was a 43% reduction in time in hypoglycemia with flash CGM compared with SMBG. Moreover, patient satisfaction improved with flash CGM, usage adherence rates were high, and flash CGM was well tolerated. Conclusions: The findings from these trials suggest that improved care outcomes can be achieved when flash CGM is integrated into current established clinical care paradigms. Flash CGM provides important advantages over SMBG that are likely to be applicable to real-world care of individuals with differing forms of diabetes requiring intensive insulin treatment.

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Section: Clinical Implications Of Flash Continuous Glucose Monitoringmentioning

confidence: 92%

Section: Traditional Continuous Glucose Monitoringmentioning

confidence: 99%

Section: Recent Clinical Trials Of Flash Continuous Glucose Monitorinmentioning

confidence: 99%

“…13 For safety reasons, individuals judged to have ongoing, clinically significant hypoglycemia unawareness were excluded from either study.…”

Section: Recent Clinical Trials Of Flash Continuous Glucose Monitorinmentioning

confidence: 99%

Section: Recent Clinical Trials Of Flash Continuous Glucose Monitorinmentioning

confidence: 99%

See 3 more Smart Citations

Flash Continuous Glucose Monitoring and its IMPACT to REPLACE Blood Glucose Monitoring in the Management of Type 1 and Type 2 Diabetes

Twigg¹,

Kazemi²,

Craig³

2017

US Endocrinology

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Comprehensive Telehealth Model to Support Diabetes Self-Management

Aleppo,

Gal,

Raghinaru

et al. 2023

JAMA Netw Open

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ImportanceAs the number of patients with diabetes continues to increase in the United States, novel approaches to clinical care access should be considered to meet the care needs for this population, including support for diabetes-related technology.ObjectiveTo evaluate a virtual clinic to facilitate comprehensive diabetes care, support continuous glucose monitoring (CGM) integration into diabetes self-management, and provide behavioral health support for diabetes-related issues.Design, Setting, and ParticipantsThis cohort study was a prospective, single-arm, remote study involving adult participants with type 1 or type 2 diabetes who were referred through community resources. The study was conducted virtually from August 24, 2020, to May 26, 2022; analysis was conducted at the clinical coordinating center.InterventionTraining and education led by a Certified Diabetes Care and Education Specialist for CGM use through a virtual endocrinology clinic structure, which included endocrinologists and behavioral health team members.Main Outcomes and MeasuresMain outcomes included CGM-measured mean glucose level, coefficient of variation, and time in range (TIR) of 70 to 180 mg/dL, time with values greater than 180 mg/dL or 250 mg/dL, and time with values less than 70 mg/dL or 54 mg/dL. Hemoglobin A1c was measured at baseline and at 12 and 24 weeks.ResultsAmong the 234 participants, 160 had type 1 diabetes and 74 had type 2 diabetes. The mean (SD) age was 47 (14) years, 123 (53%) were female, and median diabetes duration was 20 years. Median (IQR) CGM use over 6 months was 96% (91%-98%) for participants with type 1 diabetes and 94% (85%-97%) for those with type 2 diabetes. Mean (SD) hemoglobin A1c (HbA1c) in those with type 1 diabetes decreased from 7.8% (1.6%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (1.0%) at 6 months (mean change from baseline to 6 months, −0.6%, 95% CI, −0.8% to −0.5%; P &lt; .001), with an 11% mean TIR increase over 6 months (95% CI, 9% to 14%; P &lt; .001). Mean HbA1c in participants with type 2 diabetes decreased from 8.1% (1.7%) at baseline to 7.1% (1.0%) at 3 months and 7.1% (0.9%) at 6 months (mean change from baseline to 6 months, −1.0%; 95% CI, −1.4% to −0.7%; P &lt; .001), with an 18% TIR increase over 6 months (95% CI, 13% to 24%; P &lt; .001). In participants with type 1 diabetes, mean percentage of time with values less than 70 mg/dL and less than 54 mg/dL decreased over 6 months by 0.8% (95% CI, −1.2% to −0.4%; P = .001) and by 0.3% (95% CI, −0.5% to −0.2%, P &lt; .001), respectively. In the type 2 diabetes group, hypoglycemia was rare (mean [SD] percentage of time &lt;70 mg/dL, 0.5% [0.6%]; and &lt;54 mg/dL, 0.07% [0.14%], over 6 months).Conclusions and RelevanceResults from this cohort study demonstrated clinical benefits associated with implementation of a comprehensive care model that included diabetes education. This model of care has potential to reach a large portion of patients with diabetes, facilitate diabetes technology adoption, and improve glucose control.

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Hypoglycaemia and its management in primary care setting

Ibrahim¹,

Baker

Cahn³

et al. 2020

Diabetes Metabolism Res

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Hypoglycaemia is common in patients with type 1 diabetes and type 2 diabetes and constitutes a major limiting factor in achieving glycaemic control among people with diabetes. While hypoglycaemia is defined as a blood glucose level under 70 mg/dL (3.9 mmol/L), symptoms may occur at higher blood glucose levels in individuals with poor glycaemic control. Severe hypoglycaemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions to assure neurologic recovery. Hypoglycaemia is the most important safety outcome in clinical studies of glucose lowering agents. The American Diabetes Association Standards of Medical Care recommends that a management protocol for hypoglycaemia should be designed and implemented by every hospital, along with a clear prevention and treatment plan. A tailored approach, using clinical and pathophysiologic disease stratification, can help individualize glycaemic goals and promote new therapies to improve quality of life of patients. Data from recent large clinical trials reported low risk of hypoglycaemic events with the use of newer anti‐diabetic drugs. Increased hypoglycaemia risk is observed with the use of insulin and/or sulphonylureas. Vulnerable patients with T2D at dual risk of severe hypoglycaemia and cardiovascular outcomes show features of “frailty.” Many of such patients may be better treated by the use of GLP‐1 receptor agonists or SGLT2 inhibitors rather than insulin. Continuous glucose monitoring (CGM) should be considered for all individuals with increased risk for hypoglycaemia, impaired hypoglycaemia awareness, frequent nocturnal hypoglycaemia and with history of severe hypoglycaemia. Patients with impaired awareness of hypoglycaemia benefit from real‐time CGM. The diabetes educator is an invaluable resource and can devote the time needed to thoroughly educate the individual to reduce the risk of hypoglycaemia and integrate the information within the entire construct of diabetes self‐management. Conversations about hypoglycaemia facilitated by a healthcare professional may reduce the burden and fear of hypoglycaemia among patients with diabetes and their family members. Optimizing insulin doses and carbohydrate intake, in addition to a short warm up before or after the physical activity sessions may help avoiding hypoglycaemia. Several therapeutic considerations are important to reduce hypoglycaemia risk during pregnancy including administration of rapid‐acting insulin analogues rather than human insulin, pre‐conception initiation of insulin analogues, and immediate postpartum insulin dose reduction.

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Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes

Cited by 171 publications

References 20 publications

Flash Continuous Glucose Monitoring and its IMPACT to REPLACE Blood Glucose Monitoring in the Management of Type 1 and Type 2 Diabetes

Flash Continuous Glucose Monitoring and its IMPACT to REPLACE Blood Glucose Monitoring in the Management of Type 1 and Type 2 Diabetes

Comprehensive Telehealth Model to Support Diabetes Self-Management

Hypoglycaemia and its management in primary care setting

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