Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes

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Abstract

Introduction

The impact of flash glucose monitoring technology on HbA1c in type 2 diabetes managed by basal bolus insulin is uncertain. Three parallel European retrospective non-interventional chart review studies collected data reported in medical records. Each country’s study aim was to determine the effectiveness of the device on HbA1c when used by their population for 3–6 months as their standard of care for management of glycaemia in a real-world setting.

Methods

Medical records were eligible for adult patients with type 2 diabetes, on a basal bolus insulin regimen for 1 year or more, device use for 3 months or more before the start of the study, an HbA1c concentration up to 3 months prior to starting device use (patients were using blood glucose monitoring for self-management) between 64 and 108 mmol/mol (8.0–12.0%) plus an HbA1c determination 3–6 months after commencing flash glucose monitoring use.

Results

Records were analysed from 18 medical centres in Austria ( n = 92), France ( n = 88) and Germany ( n = 183). Baseline HbA1c results, recorded up to 90 days before the start of device use, were comparable across the three countries and were reduced significantly by 9.6 ± 8.8 mmol/mol mean ± SD (Austria [0.9 ± 0.8%], p < 0.0001), 8.9 ± 12.5 mmol/mol (France [0.8% ± 1.1], p < 0.0001) and 10.1 ± 12.2 mmol/mol (Germany [0.9% ± 1.1], p < 0.0001). No significant differences were detected between age group, sex, BMI or duration of insulin use.

Conclusions

Three European real-world, chart review studies in people with type 2 diabetes managed using basal bolus insulin therapy each concluded that HbA1c was significantly reduced after changing to use of flash glucose monitoring for 3–6 months in a real-world setting.

Electronic supplementary material

The online version of this article (10.1007/s13300-019-00741-9) contains supplementary material, which is available to authorized users.

Related collections

Most cited references 12

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Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

Thomas Haak, Hélène Hanaire, Ramzi A Ajjan … (2016)

Introduction Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild). Conclusion Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG. Trial registration ClinicalTrials.gov identifier: NCT02082184. Funding Abbott Diabetes Care. Electronic supplementary material The online version of this article (doi:10.1007/s13300-016-0223-6) contains supplementary material, which is available to authorized users.

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Generalisability of The Health Improvement Network (THIN) database: demographics, chronic disease prevalence and mortality rates.

Betina Blak, Mary Thompson, Hassy Dattani … (2011)

The degree of generalisability of patient databases to the general population is important for interpreting database research. This report describes the representativeness of The Health Improvement Network (THIN), a UK primary care database, of the UK population. Demographics, deprivation (Townsend), Quality and Outcomes Framework (QOF) condition prevalence and deaths from THIN were compared with national statistical and QOF 2006/2007 data. Demographics were similar although THIN contained fewer people aged under 25 years. Condition prevalence was comparable, e.g. 3.5% diabetes prevalence in THIN, 3.7% nationally. More THIN patients lived in the most affluent areas (23.5% in THIN, 20% nationally). Between 1990 and 2009, standardised mortality ratio ranged from 0.81 (95% CI: 0.39-1.49; 1990) to 0.93 (95% CI: 0.48-1.64; 1995). Adjusting for demographics/deprivation, the 2006 THIN death rate was 9.08/1000 population close to the national death rate of 9.4/1000 population. THIN is generalisable to the UK for demographics, major condition prevalence and death rates adjusted for demographics and deprivation.

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Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections

Andrew Ahmann, Katrina Ruedy, Tonya Riddlesworth … (2017)

Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type 1 diabetes, has not been well-evaluated in those with type 2 diabetes receiving insulin.

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All references

Author and article information

Contributors

Jens Kröger: Dr.J.Kroeger@t-online.de

Journal

Journal ID (nlm-ta): Diabetes Ther

Journal ID (iso-abbrev): Diabetes Ther

Title: Diabetes Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 1869-6953

ISSN (Electronic): 1869-6961

Publication date (Electronic): 12 December 2019

Publication date PMC-release: 12 December 2019

Publication date (Print): January 2020

Volume: 11

Issue: 1

Pages: 279-291

Affiliations

[1 ]Zentrum für Diabetologie Hamburg Bergedorf, Glindersweg 80 Haus E, 21029 Hamburg, Germany

[2 ]GRID grid.417109.a, ISNI 0000 0004 0524 3028, Wilhelminenspital der Stadt Wien, ; Vienna, Austria

[3 ]GRID grid.411175.7, ISNI 0000 0001 1457 2980, Centre Hospitalier Universitaire Toulouse, Hospital Rangueil, ; Toulouse, France

Article

Publisher ID: 741

DOI: 10.1007/s13300-019-00741-9

PMC ID: 6965548

PubMed ID: 31833041

SO-VID: 0bad78d0-16df-4023-8973-9a229302eb82

History

Date received : 1 November 2019

Funding

Funded by: Abbott Diabetes Care (US)

Custom metadata

ScienceOpen disciplines: Endocrinology & Diabetes

Keywords: flash sensor glucose monitoring,hba1c,insulin,isc-cgm,type 2 diabetes

Data availability:

ScienceOpen disciplines: Endocrinology & Diabetes

Keywords: flash sensor glucose monitoring, hba1c, insulin, isc-cgm, type 2 diabetes

Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes

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