Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial

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

doi:10.2337/dc17-2682

Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial

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

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

Abstract

OBJECTIVE: Severe hypoglycemia is a feared complication of type 1 diabetes; yet, few trials have targeted prevention using optimized self-management (educational, therapeutic, and technological support). We aimed to investigate whether improved awareness and reduced severe hypoglycemia, achieved during an intensive randomized clinical trial (RCT), were sustained after return to routine care.

RESEARCH DESIGN AND METHODS: Ninety-six adults with type 1 diabetes (29 ± 12 years' duration) and impaired awareness of hypoglycemia at five U.K. tertiary referral diabetes centers were recruited into a 24-week 2 × 2 factorial RCT (HypoCOMPaSS). Participants were randomized to pump (continuous subcutaneous insulin infusion [CSII]) or multiple daily injections (MDIs) and real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG), with equal education/attention to all groups. At 24 weeks, participants returned to routine care with follow-up until 24 months, including free choice of MDI/CSII; RT-CGM vs. SMBG comparison continued to 24 months. Primary outcome was mean difference (baseline to 24 months [between groups]) in hypoglycemia awareness.

RESULTS: Improvement in hypoglycemia awareness was sustained (Gold score at baseline 5.1 ± 1.1 vs. 24 months 3.7 ± 1.9; P < 0.0001). Severe hypoglycemia rate was reduced from 8.9 ± 12.8 episodes/person-year over the 12 months prestudy to 0.4 ± 0.8 over 24 months (P < 0.0001). HbA1c improved (baseline 8.2 ± 3.2% [66 ± 12 mmol/mol] vs. 24 months 7.7 ± 3.1% [61 ± 10 mmol/mol]; P = 0.003). Improvement in treatment satisfaction and reduced fear of hypoglycemia were sustained. There were no significant differences between interventions at 24 months.

CONCLUSIONS: Optimized insulin replacement and glucose monitoring underpinned by hypoglycemia-focused structured education should be provided to all with type 1 diabetes complicated by impaired awareness of hypoglycemia.

Original language	English
Pages (from-to)	1600-1607
Number of pages	8
Journal	Diabetes Care
Volume	41
Issue number	8
DOIs	https://doi.org/10.2337/dc17-2682
Publication status	Published - 1 Aug 2018
Externally published	Yes

Keywords

Adult
Awareness
Blood Glucose/drug effects
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1/blood
Female
Follow-Up Studies
Glycated Hemoglobin A/analysis
Humans
Hypoglycemia/blood
Injections
Insulin/administration & dosage
Insulin Infusion Systems
Male
Middle Aged
Severity of Illness Index

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.2337/dc17-2682

Cite this

Little, S. A., Speight, J., Leelarathna, L., Walkinshaw, E., Tan, H. K., Bowes, A., Lubina-Solomon, A., Chadwick, T. J., Stocken, D. D., Brennand, C., Marshall, S. M., Wood, R., Kerr, D., Flanagan, D., Heller, S. R., Evans, M. L., & Shaw, J. A. M. (2018). Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial. Diabetes Care, 41(8), 1600-1607. https://doi.org/10.2337/dc17-2682

@article{5eba15275ec749479a0d00b566151012,

title = "Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial",

abstract = "OBJECTIVE: Severe hypoglycemia is a feared complication of type 1 diabetes; yet, few trials have targeted prevention using optimized self-management (educational, therapeutic, and technological support). We aimed to investigate whether improved awareness and reduced severe hypoglycemia, achieved during an intensive randomized clinical trial (RCT), were sustained after return to routine care.RESEARCH DESIGN AND METHODS: Ninety-six adults with type 1 diabetes (29 ± 12 years' duration) and impaired awareness of hypoglycemia at five U.K. tertiary referral diabetes centers were recruited into a 24-week 2 × 2 factorial RCT (HypoCOMPaSS). Participants were randomized to pump (continuous subcutaneous insulin infusion [CSII]) or multiple daily injections (MDIs) and real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG), with equal education/attention to all groups. At 24 weeks, participants returned to routine care with follow-up until 24 months, including free choice of MDI/CSII; RT-CGM vs. SMBG comparison continued to 24 months. Primary outcome was mean difference (baseline to 24 months [between groups]) in hypoglycemia awareness.RESULTS: Improvement in hypoglycemia awareness was sustained (Gold score at baseline 5.1 ± 1.1 vs. 24 months 3.7 ± 1.9; P < 0.0001). Severe hypoglycemia rate was reduced from 8.9 ± 12.8 episodes/person-year over the 12 months prestudy to 0.4 ± 0.8 over 24 months (P < 0.0001). HbA1c improved (baseline 8.2 ± 3.2% [66 ± 12 mmol/mol] vs. 24 months 7.7 ± 3.1% [61 ± 10 mmol/mol]; P = 0.003). Improvement in treatment satisfaction and reduced fear of hypoglycemia were sustained. There were no significant differences between interventions at 24 months.CONCLUSIONS: Optimized insulin replacement and glucose monitoring underpinned by hypoglycemia-focused structured education should be provided to all with type 1 diabetes complicated by impaired awareness of hypoglycemia.",

keywords = "Adult, Awareness, Blood Glucose/drug effects, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1/blood, Female, Follow-Up Studies, Glycated Hemoglobin A/analysis, Humans, Hypoglycemia/blood, Injections, Insulin/administration & dosage, Insulin Infusion Systems, Male, Middle Aged, Severity of Illness Index",

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

note = "{\textcopyright} 2018 by the American Diabetes Association.",

year = "2018",

month = aug,

day = "1",

doi = "10.2337/dc17-2682",

language = "English",

volume = "41",

pages = "1600--1607",

journal = "Diabetes Care",

issn = "0149-5992",

publisher = "American Diabetes Association ",

number = "8",

}

Little, SA, Speight, J, Leelarathna, L, Walkinshaw, E, Tan, HK, Bowes, A, Lubina-Solomon, A, Chadwick, TJ, Stocken, DD, Brennand, C, Marshall, SM, Wood, R, Kerr, D, Flanagan, D, Heller, SR, Evans, ML & Shaw, JAM 2018, 'Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial', Diabetes Care, vol. 41, no. 8, pp. 1600-1607. https://doi.org/10.2337/dc17-2682

Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial. / Little, Stuart A; Speight, Jane; Leelarathna, Lalantha et al.
In: Diabetes Care, Vol. 41, No. 8, 01.08.2018, p. 1600-1607.

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

TY - JOUR

T1 - Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia

T2 - Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial

AU - Little, Stuart A

AU - Speight, Jane

AU - Leelarathna, Lalantha

AU - Walkinshaw, Emma

AU - Tan, Horng Kai

AU - Bowes, Anita

AU - Lubina-Solomon, Alexandra

AU - Chadwick, Thomas J

AU - Stocken, Deborah D

AU - Brennand, Catherine

AU - Marshall, Sally M

AU - Wood, Ruth

AU - Kerr, David

AU - Flanagan, Daniel

AU - Heller, Simon R

AU - Evans, Mark L

AU - Shaw, James A M

PY - 2018/8/1

Y1 - 2018/8/1

N2 - OBJECTIVE: Severe hypoglycemia is a feared complication of type 1 diabetes; yet, few trials have targeted prevention using optimized self-management (educational, therapeutic, and technological support). We aimed to investigate whether improved awareness and reduced severe hypoglycemia, achieved during an intensive randomized clinical trial (RCT), were sustained after return to routine care.RESEARCH DESIGN AND METHODS: Ninety-six adults with type 1 diabetes (29 ± 12 years' duration) and impaired awareness of hypoglycemia at five U.K. tertiary referral diabetes centers were recruited into a 24-week 2 × 2 factorial RCT (HypoCOMPaSS). Participants were randomized to pump (continuous subcutaneous insulin infusion [CSII]) or multiple daily injections (MDIs) and real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG), with equal education/attention to all groups. At 24 weeks, participants returned to routine care with follow-up until 24 months, including free choice of MDI/CSII; RT-CGM vs. SMBG comparison continued to 24 months. Primary outcome was mean difference (baseline to 24 months [between groups]) in hypoglycemia awareness.RESULTS: Improvement in hypoglycemia awareness was sustained (Gold score at baseline 5.1 ± 1.1 vs. 24 months 3.7 ± 1.9; P < 0.0001). Severe hypoglycemia rate was reduced from 8.9 ± 12.8 episodes/person-year over the 12 months prestudy to 0.4 ± 0.8 over 24 months (P < 0.0001). HbA1c improved (baseline 8.2 ± 3.2% [66 ± 12 mmol/mol] vs. 24 months 7.7 ± 3.1% [61 ± 10 mmol/mol]; P = 0.003). Improvement in treatment satisfaction and reduced fear of hypoglycemia were sustained. There were no significant differences between interventions at 24 months.CONCLUSIONS: Optimized insulin replacement and glucose monitoring underpinned by hypoglycemia-focused structured education should be provided to all with type 1 diabetes complicated by impaired awareness of hypoglycemia.

AB - OBJECTIVE: Severe hypoglycemia is a feared complication of type 1 diabetes; yet, few trials have targeted prevention using optimized self-management (educational, therapeutic, and technological support). We aimed to investigate whether improved awareness and reduced severe hypoglycemia, achieved during an intensive randomized clinical trial (RCT), were sustained after return to routine care.RESEARCH DESIGN AND METHODS: Ninety-six adults with type 1 diabetes (29 ± 12 years' duration) and impaired awareness of hypoglycemia at five U.K. tertiary referral diabetes centers were recruited into a 24-week 2 × 2 factorial RCT (HypoCOMPaSS). Participants were randomized to pump (continuous subcutaneous insulin infusion [CSII]) or multiple daily injections (MDIs) and real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG), with equal education/attention to all groups. At 24 weeks, participants returned to routine care with follow-up until 24 months, including free choice of MDI/CSII; RT-CGM vs. SMBG comparison continued to 24 months. Primary outcome was mean difference (baseline to 24 months [between groups]) in hypoglycemia awareness.RESULTS: Improvement in hypoglycemia awareness was sustained (Gold score at baseline 5.1 ± 1.1 vs. 24 months 3.7 ± 1.9; P < 0.0001). Severe hypoglycemia rate was reduced from 8.9 ± 12.8 episodes/person-year over the 12 months prestudy to 0.4 ± 0.8 over 24 months (P < 0.0001). HbA1c improved (baseline 8.2 ± 3.2% [66 ± 12 mmol/mol] vs. 24 months 7.7 ± 3.1% [61 ± 10 mmol/mol]; P = 0.003). Improvement in treatment satisfaction and reduced fear of hypoglycemia were sustained. There were no significant differences between interventions at 24 months.CONCLUSIONS: Optimized insulin replacement and glucose monitoring underpinned by hypoglycemia-focused structured education should be provided to all with type 1 diabetes complicated by impaired awareness of hypoglycemia.

KW - Adult

KW - Awareness

KW - Blood Glucose/drug effects

KW - Blood Glucose Self-Monitoring

KW - Diabetes Mellitus, Type 1/blood

KW - Female

KW - Follow-Up Studies

KW - Glycated Hemoglobin A/analysis

KW - Humans

KW - Hypoglycemia/blood

KW - Injections

KW - Insulin/administration & dosage

KW - Insulin Infusion Systems

KW - Male

KW - Middle Aged

KW - Severity of Illness Index

U2 - 10.2337/dc17-2682

DO - 10.2337/dc17-2682

M3 - Article

C2 - 29661916

SN - 0149-5992

VL - 41

SP - 1600

EP - 1607

JO - Diabetes Care

JF - Diabetes Care

IS - 8

ER -

Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial

Abstract

Keywords

UN SDGs

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