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Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.
Diabet Med. 2011 Oct; 28(10):1158-67.DM

Abstract

AIMS

To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes.

METHODS

In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed.

RESULTS

The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group.

CONCLUSIONS

Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections.

Authors+Show Affiliations

Department of Internal Medicine, Academic Medical Centre, Amsterdam, The Netherlands. j.hermanides@amc.uva.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21294770

Citation

Hermanides, J, et al. "Sensor-augmented Pump Therapy Lowers HbA(1c) in Suboptimally Controlled Type 1 Diabetes; a Randomized Controlled Trial." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 28, no. 10, 2011, pp. 1158-67.
Hermanides J, Nørgaard K, Bruttomesso D, et al. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial. Diabet Med. 2011;28(10):1158-67.
Hermanides, J., Nørgaard, K., Bruttomesso, D., Mathieu, C., Frid, A., Dayan, C. M., Diem, P., Fermon, C., Wentholt, I. M., Hoekstra, J. B., & DeVries, J. H. (2011). Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial. Diabetic Medicine : a Journal of the British Diabetic Association, 28(10), 1158-67. https://doi.org/10.1111/j.1464-5491.2011.03256.x
Hermanides J, et al. Sensor-augmented Pump Therapy Lowers HbA(1c) in Suboptimally Controlled Type 1 Diabetes; a Randomized Controlled Trial. Diabet Med. 2011;28(10):1158-67. PubMed PMID: 21294770.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial. AU - Hermanides,J, AU - Nørgaard,K, AU - Bruttomesso,D, AU - Mathieu,C, AU - Frid,A, AU - Dayan,C M, AU - Diem,P, AU - Fermon,C, AU - Wentholt,I M E, AU - Hoekstra,J B L, AU - DeVries,J H, PY - 2011/2/8/entrez PY - 2011/2/8/pubmed PY - 2011/12/13/medline SP - 1158 EP - 67 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet Med VL - 28 IS - 10 N2 - AIMS: To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. METHODS: In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed. RESULTS: The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group. CONCLUSIONS: Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/21294770/Sensor_augmented_pump_therapy_lowers_HbA_1c__in_suboptimally_controlled_Type_1_diabetes L2 - https://doi.org/10.1111/j.1464-5491.2011.03256.x DB - PRIME DP - Unbound Medicine ER -