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Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS).
Diabetes Care. 2014 Aug; 37(8):2114-22.DC

Abstract

OBJECTIVE

To determine whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes, we compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG).

RESEARCH DESIGN AND METHODS

A 24-week 2 × 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted. All received comparable education, support, and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control. Primary end point was between-intervention difference in 24-week hypoglycemia awareness (Gold score).

RESULTS

A total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (≤3.0 mmol/L) decreased (53 ± 63 to 24 ± 56 min/24 h; P = 0.004 [t test]) without deterioration in HbA1c. Hypoglycemia awareness improved (5.1 ± 1.1 to 4.1 ± 1.6; P = 0.0001 [t test]) with decreased SH (8.9 ± 13.4 to 0.8 ± 1.8 episodes/patient-year; P = 0.0001 [t test]). At 24 weeks, there was no significant difference in awareness comparing CSII with MDI (4.1 ± 1.6 vs. 4.2 ± 1.7; difference 0.1; 95% CI -0.6 to 0.8) and RT with SMBG (4.3 ± 1.6 vs. 4.0 ± 1.7; difference -0.3; 95% CI -1.0 to 0.4). Between-group analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA1c. Treatment satisfaction was higher with CSII than MDI (32 ± 3 vs. 29 ± 6; P = 0.0003 [t test]), but comparable with SMBG and RT (30 ± 5 vs. 30 ± 5; P = 0.79 [t test]).

CONCLUSIONS

Hypoglycemia awareness can be improved and recurrent SH prevented in long-standing type 1 diabetes without relaxing HbA1c. Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT, although satisfaction was higher with CSII.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Little SA
Institute of Cellular Medicine, Newcastle University, Newcastle, U.K.
Leelarathna L
Wellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.
Walkinshaw E
School of Medicine and Biomedical Sciences, Sheffield University, U.K.
Tan HK
Peninsula College of Medicine and Dentistry, Plymouth, U.K.
Chapple O
Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K.
Lubina-Solomon A
School of Medicine and Biomedical Sciences, Sheffield University, U.K.
Chadwick TJ
Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, Newcastle, U.K.
Barendse S
AHP Research, Hornchurch, U.K.
Stocken DD
Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, Newcastle, U.K.
Brennand C
Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, Newcastle, U.K.
Marshall SM
Institute of Cellular Medicine, Newcastle University, Newcastle, U.K.
Wood R
Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, Newcastle, U.K.
Speight J
AHP Research, Hornchurch, U.K.The Australian Centre for Behavioural Research in Diabetes, Diabetes Australia-Vic, Melbourne, AustraliaCentre for Mental Health and Wellbeing Research, School of Psychology, Deakin University, Burwood, Australia.
Kerr D
Centre for Postgraduate Medical Research and Education, Bournemouth University, U.K.
Flanagan D
Peninsula College of Medicine and Dentistry, Plymouth, U.K.
Heller SR
School of Medicine and Biomedical Sciences, Sheffield University, U.K.
Evans ML
Wellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.
Shaw JA
Institute of Cellular Medicine, Newcastle University, Newcastle, U.K.

MeSH

AdolescentAdultAgedAwarenessBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Drug Administration ScheduleFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInfusions, SubcutaneousInjectionsInsulinInsulin Infusion SystemsMaleMiddle AgedPatient SatisfactionRecurrenceYoung Adult

Pub Type(s)

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

Language

eng

PubMed ID

24854041

Citation

Little, Stuart A., et al. "Recovery of Hypoglycemia Awareness in Long-standing Type 1 Diabetes: a Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-monitoring (HypoCOMPaSS)." Diabetes Care, vol. 37, no. 8, 2014, pp. 2114-22.
Little SA, Leelarathna L, Walkinshaw E, et al. Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care. 2014;37(8):2114-22.
Little, S. A., Leelarathna, L., Walkinshaw, E., Tan, H. K., Chapple, O., Lubina-Solomon, A., Chadwick, T. J., Barendse, S., Stocken, D. D., Brennand, C., Marshall, S. M., Wood, R., Speight, J., Kerr, D., Flanagan, D., Heller, S. R., Evans, M. L., & Shaw, J. A. (2014). Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care, 37(8), 2114-22. https://doi.org/10.2337/dc14-0030
Little SA, et al. Recovery of Hypoglycemia Awareness in Long-standing Type 1 Diabetes: a Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-monitoring (HypoCOMPaSS). Diabetes Care. 2014;37(8):2114-22. PubMed PMID: 24854041.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). AU - Little,Stuart A, AU - Leelarathna,Lalantha, AU - Walkinshaw,Emma, AU - Tan,Horng Kai, AU - Chapple,Olivia, AU - Lubina-Solomon,Alexandra, AU - Chadwick,Thomas J, AU - Barendse,Shalleen, AU - Stocken,Deborah D, AU - Brennand,Catherine, AU - Marshall,Sally M, AU - Wood,Ruth, AU - Speight,Jane, AU - Kerr,David, AU - Flanagan,Daniel, AU - Heller,Simon R, AU - Evans,Mark L, AU - Shaw,James A M, Y1 - 2014/05/22/ PY - 2014/5/24/entrez PY - 2014/5/24/pubmed PY - 2015/9/15/medline SP - 2114 EP - 22 JF - Diabetes care JO - Diabetes Care VL - 37 IS - 8 N2 - OBJECTIVE: To determine whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes, we compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG). RESEARCH DESIGN AND METHODS: A 24-week 2 × 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted. All received comparable education, support, and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control. Primary end point was between-intervention difference in 24-week hypoglycemia awareness (Gold score). RESULTS: A total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (≤3.0 mmol/L) decreased (53 ± 63 to 24 ± 56 min/24 h; P = 0.004 [t test]) without deterioration in HbA1c. Hypoglycemia awareness improved (5.1 ± 1.1 to 4.1 ± 1.6; P = 0.0001 [t test]) with decreased SH (8.9 ± 13.4 to 0.8 ± 1.8 episodes/patient-year; P = 0.0001 [t test]). At 24 weeks, there was no significant difference in awareness comparing CSII with MDI (4.1 ± 1.6 vs. 4.2 ± 1.7; difference 0.1; 95% CI -0.6 to 0.8) and RT with SMBG (4.3 ± 1.6 vs. 4.0 ± 1.7; difference -0.3; 95% CI -1.0 to 0.4). Between-group analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA1c. Treatment satisfaction was higher with CSII than MDI (32 ± 3 vs. 29 ± 6; P = 0.0003 [t test]), but comparable with SMBG and RT (30 ± 5 vs. 30 ± 5; P = 0.79 [t test]). CONCLUSIONS: Hypoglycemia awareness can be improved and recurrent SH prevented in long-standing type 1 diabetes without relaxing HbA1c. Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT, although satisfaction was higher with CSII. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/24854041/Recovery_of_hypoglycemia_awareness_in_long_standing_type_1_diabetes:_a_multicenter_2_×_2_factorial_randomized_controlled_trial_comparing_insulin_pump_with_multiple_daily_injections_and_continuous_with_conventional_glucose_self_monitoring__HypoCOMPaSS__ DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓67]

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