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)

Stuart A Little; Lalantha Leelarathna; Emma Walkinshaw; Horng Kai Tan; Olivia Chapple; Alexandra Lubina-Solomon; Thomas J Chadwick; Shalleen Barendse; Deborah D Stocken; Catherine Brennand; Sally M Marshall; Ruth Wood; Jane Speight; David Kerr; Daniel Flanagan; Simon R Heller; Mark L Evans; James A M Shaw

doi:10.2337/dc14-0030

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)

Stuart A Little, Lalantha Leelarathna, Emma Walkinshaw, Horng Kai Tan, Olivia Chapple, Alexandra Lubina-Solomon, Thomas J Chadwick, Shalleen Barendse, Deborah D Stocken, Catherine Brennand, Sally M Marshall, Ruth Wood, Jane Speight, David Kerr, Daniel Flanagan, Simon R Heller, Mark L Evans, James A M Shaw

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	2114-2122
Number of pages	9
Journal	Diabetes Care
Volume	37
Issue number	8
DOIs	https://doi.org/10.2337/dc14-0030
Publication status	Published - Aug 2014

Keywords

Adolescent
Adult
Aged
Awareness
Blood Glucose/metabolism
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1/blood
Drug Administration Schedule
Female
Glycated Hemoglobin A/metabolism
Humans
Hypoglycemia/blood
Hypoglycemic Agents/administration & dosage
Infusions, Subcutaneous
Injections
Insulin/administration & dosage
Insulin Infusion Systems
Male
Middle Aged
Patient Satisfaction
Recurrence
Young Adult

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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. M. (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), 2114-2122. https://doi.org/10.2337/dc14-0030

Little, Stuart A ; Leelarathna, Lalantha ; Walkinshaw, Emma 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). In: Diabetes Care. 2014 ; Vol. 37, No. 8. pp. 2114-2122.

@article{5988de6b807c4d3bbb674e4f1f4ea509,

title = "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)",

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.",

keywords = "Adolescent, Adult, Aged, Awareness, Blood Glucose/metabolism, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1/blood, Drug Administration Schedule, Female, Glycated Hemoglobin A/metabolism, Humans, Hypoglycemia/blood, Hypoglycemic Agents/administration & dosage, Infusions, Subcutaneous, Injections, Insulin/administration & dosage, Insulin Infusion Systems, Male, Middle Aged, Patient Satisfaction, Recurrence, Young Adult",

author = "Little, {Stuart A} and Lalantha Leelarathna and Emma Walkinshaw and Tan, {Horng Kai} and Olivia Chapple and Alexandra Lubina-Solomon and Chadwick, {Thomas J} and Shalleen Barendse and Stocken, {Deborah D} and Catherine Brennand and Marshall, {Sally M} and Ruth Wood and Jane Speight and David Kerr and Daniel Flanagan and Heller, {Simon R} and Evans, {Mark L} and Shaw, {James A M}",

note = "{\textcopyright} 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.",

year = "2014",

month = aug,

doi = "10.2337/dc14-0030",

language = "English",

volume = "37",

pages = "2114--2122",

journal = "Diabetes Care",

issn = "0149-5992",

publisher = "American Diabetes Association Inc.",

number = "8",

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Little, SA, Leelarathna, L, Walkinshaw, E, Tan, HK, Chapple, O, Lubina-Solomon, A, Chadwick, TJ, Barendse, S, Stocken, DD, Brennand, C, Marshall, SM, Wood, R, Speight, J, Kerr, D, Flanagan, D, Heller, SR, Evans, ML & Shaw, JAM 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, vol. 37, no. 8, pp. 2114-2122. https://doi.org/10.2337/dc14-0030

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). / Little, Stuart A; Leelarathna, Lalantha; Walkinshaw, Emma et al.
In: Diabetes Care, Vol. 37, No. 8, 08.2014, p. 2114-2122.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Recovery of hypoglycemia awareness in long-standing type 1 diabetes

T2 - 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

PY - 2014/8

Y1 - 2014/8

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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Awareness

KW - Blood Glucose/metabolism

KW - Blood Glucose Self-Monitoring

KW - Diabetes Mellitus, Type 1/blood

KW - Drug Administration Schedule

KW - Female

KW - Glycated Hemoglobin A/metabolism

KW - Humans

KW - Hypoglycemia/blood

KW - Hypoglycemic Agents/administration & dosage

KW - Infusions, Subcutaneous

KW - Injections

KW - Insulin/administration & dosage

KW - Insulin Infusion Systems

KW - Male

KW - Middle Aged

KW - Patient Satisfaction

KW - Recurrence

KW - Young Adult

U2 - 10.2337/dc14-0030

DO - 10.2337/dc14-0030

M3 - Article

C2 - 24854041

SN - 0149-5992

VL - 37

SP - 2114

EP - 2122

JO - Diabetes Care

JF - Diabetes Care

IS - 8

ER -

Little SA, Leelarathna L, Walkinshaw E, Tan HK, Chapple O, Lubina-Solomon 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. 2014 Aug;37(8):2114-2122. doi: 10.2337/dc14-0030