Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA <inf>1c</inf> in insulin-treated diabetes (MITRE Study)

Authors: Cooke, D., Kerr, D. et al.

Journal: Diabetic Medicine

Volume: 26

Issue: 5

Pages: 540-547

eISSN: 1464-5491

ISSN: 0742-3071

DOI: 10.1111/j.1464-5491.2009.02723.x

Abstract:

Aims: To determine whether continuous glucose information provided through use of either the GlucoWatch G2 Biographer or the MiniMed continuous glucose monitoring system (CGMS) results in improved glycated haemoglobin (HbA 1c) for insulin-treated adults with diabetes mellitus, relative to an attention control and standard care group. Methods: Four hundred and four adults taking at least two daily insulin injections and with two consecutive HbA 1c values ≥ 7.5% were recruited to this randomized controlled trial (RCT). All were trained at baseline to use the same monitor for traditional capillary glucose testing throughout the 18-month study. The CGMS group were asked to wear the device three times during the first 3 months of the trial and on another three occasions thereafter. The GlucoWatch group wore the device a minimum of four times per month and a maximum of four times per week during the first 3 months and as desired for the remainder of the trial. Trained diabetes research nurses used downloaded data to guide therapy adjustments. Proportional reduction in HbA 1c from baseline to 18 months was the primary outcome measure. Results: Neither an intention-to-treat nor per-protocol analysis showed improvement in HbA 1c in the device groups compared with standard care. For the intention-to-treat analysis, when the standard care group was compared with each of the other groups, this equated to differences in mean relative HbA 1c reduction (95% confidence interval) from baseline to 18 months of 3.5% (-1.3 to 8.3; GlucoWatch), 0.7% (-4.1 to 5.5; CGMS), and -0.1% (-4.6 to 4.3; attention control). Conclusions: The additional information provided by these devices did not result in improvements in HbA 1c in this population. © 2009 Diabetes UK.

Source: Scopus

Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA(1c) in insulin-treated diabetes (MITRE Study).

Authors: Cooke, D., Kerr, D. et al.

Journal: Diabet Med

Volume: 26

Issue: 5

Pages: 540-547

eISSN: 1464-5491

DOI: 10.1111/j.1464-5491.2009.02723.x

Abstract:

AIMS: To determine whether continuous glucose information provided through use of either the GlucoWatch G2 Biographer or the MiniMed continuous glucose monitoring system (CGMS) results in improved glycated haemoglobin (HbA(1c)) for insulin-treated adults with diabetes mellitus, relative to an attention control and standard care group. METHODS: Four hundred and four adults taking at least two daily insulin injections and with two consecutive HbA(1c) values > or = 7.5% were recruited to this randomized controlled trial (RCT). All were trained at baseline to use the same monitor for traditional capillary glucose testing throughout the 18-month study. The CGMS group were asked to wear the device three times during the first 3 months of the trial and on another three occasions thereafter. The GlucoWatch group wore the device a minimum of four times per month and a maximum of four times per week during the first 3 months and as desired for the remainder of the trial. Trained diabetes research nurses used downloaded data to guide therapy adjustments. Proportional reduction in HbA(1c) from baseline to 18 months was the primary outcome measure. RESULTS: Neither an intention-to-treat nor per-protocol analysis showed improvement in HbA(1c) in the device groups compared with standard care. For the intention-to-treat analysis, when the standard care group was compared with each of the other groups, this equated to differences in mean relative HbA(1c) reduction (95% confidence interval) from baseline to 18 months of 3.5% (-1.3 to 8.3; GlucoWatch), 0.7% (-4.1 to 5.5; CGMS), and -0.1% (-4.6 to 4.3; attention control). CONCLUSIONS: The additional information provided by these devices did not result in improvements in HbA(1c) in this population.

Source: PubMed

Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA<sub>1c</sub> in insulin-treated diabetes (MITRE Study)

Authors: Cooke, D., Kerr, D. et al.

Journal: DIABETIC MEDICINE

Volume: 26

Issue: 5

Pages: 540-547

eISSN: 1464-5491

ISSN: 0742-3071

DOI: 10.1111/j.1464-5491.2009.02723.x

Source: Web of Science (Lite)

Randomised controlled trial to assess the impact of continuous glucose monitoring on HbA1c in insulin treated diabetes (MITRE study)

Authors: Cooke, D., Kerr, D. et al.

Journal: Diabetic Medicine

Volume: 26

Pages: 540-547

ISSN: 0742-3071

DOI: 10.1111/j.1464-5491.2009.02723.x

Abstract:

Aims To determine whether continuous glucose information provided through use of either the GlucoWatch G2 Biographer or the MiniMed continuous glucose monitoring system (CGMS) results in improved glycated haemoglobin (HbA1c) for insulin-treated adults with diabetes mellitus, relative to an attention control and standard care group.

Methods Four hundred and four adults taking at least two daily insulin injections and with two consecutive HbA1c values ≥ 7.5% were recruited to this randomized controlled trial (RCT). All were trained at baseline to use the same monitor for traditional capillary glucose testing throughout the 18-month study. The CGMS group were asked to wear the device three times during the first 3 months of the trial and on another three occasions thereafter. The GlucoWatch group wore the device a minimum of four times per month and a maximum of four times per week during the first 3 months and as desired for the remainder of the trial. Trained diabetes research nurses used downloaded data to guide therapy adjustments. Proportional reduction in HbA1c from baseline to 18 months was the primary outcome measure.

Results Neither an intention-to-treat nor per-protocol analysis showed improvement in HbA1c in the device groups compared with standard care. For the intention-to-treat analysis, when the standard care group was compared with each of the other groups, this equated to differences in mean relative HbA1c reduction (95% confidence interval) from baseline to 18 months of 3.5% (−1.3 to 8.3; GlucoWatch), 0.7% (−4.1 to 5.5; CGMS), and −0.1% (−4.6 to 4.3; attention control).

Conclusions The additional information provided by these devices did not result in improvements in HbA1c in this population.

Source: Manual

Preferred by: David Kerr

Randomized controlled trial to assess the impact of continuous glucose monitoring on HbA(1c) in insulin-treated diabetes (MITRE Study).

Authors: Cooke, D., Kerr, D. et al.

Journal: Diabetic medicine : a journal of the British Diabetic Association

Volume: 26

Issue: 5

Pages: 540-547

eISSN: 1464-5491

ISSN: 0742-3071

DOI: 10.1111/j.1464-5491.2009.02723.x

Abstract:

Aims

To determine whether continuous glucose information provided through use of either the GlucoWatch G2 Biographer or the MiniMed continuous glucose monitoring system (CGMS) results in improved glycated haemoglobin (HbA(1c)) for insulin-treated adults with diabetes mellitus, relative to an attention control and standard care group.

Methods

Four hundred and four adults taking at least two daily insulin injections and with two consecutive HbA(1c) values > or = 7.5% were recruited to this randomized controlled trial (RCT). All were trained at baseline to use the same monitor for traditional capillary glucose testing throughout the 18-month study. The CGMS group were asked to wear the device three times during the first 3 months of the trial and on another three occasions thereafter. The GlucoWatch group wore the device a minimum of four times per month and a maximum of four times per week during the first 3 months and as desired for the remainder of the trial. Trained diabetes research nurses used downloaded data to guide therapy adjustments. Proportional reduction in HbA(1c) from baseline to 18 months was the primary outcome measure.

Results

Neither an intention-to-treat nor per-protocol analysis showed improvement in HbA(1c) in the device groups compared with standard care. For the intention-to-treat analysis, when the standard care group was compared with each of the other groups, this equated to differences in mean relative HbA(1c) reduction (95% confidence interval) from baseline to 18 months of 3.5% (-1.3 to 8.3; GlucoWatch), 0.7% (-4.1 to 5.5; CGMS), and -0.1% (-4.6 to 4.3; attention control).

Conclusions

The additional information provided by these devices did not result in improvements in HbA(1c) in this population.

Source: Europe PubMed Central