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The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial

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@article{abc8e0f0de6b4955989fb2637fd7dc33,
title = "The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial",
abstract = "AIMS/HYPOTHESIS: Type 1 diabetes is characterised by reduced glucagon response to hypoglycaemia, increasing the risk of insulin treatment-associated hypoglycaemia known to hamper glycaemic control. We previously reported a glucagonotropic effect of exogenous glucose-dependent insulinotropic polypeptide (GIP) during insulin-induced hypoglycaemia in individuals with type 1 diabetes. Here we investigate the effect of a 6-day s.c. GIP infusion on time in glycaemic range as assessed by continuous glucose monitoring (CGM) in individuals with type 1 diabetes.METHODS: In a randomised, placebo-controlled, double-blind crossover study, time in glycaemic range (assessed by double-blinded CGM) was evaluated in 20 men with type 1 diabetes (18-75 years, stable insulin treatment ≥3 months, diabetes duration 2-15 years, fasting plasma C-peptide below 200 pmol/l, BMI 20-27 kg/m2, HbA1c <69 mmol/mol [8.5%]) during two × 6 days of continuous s.c. GIP (6 pmol kg-1 min-1) and placebo (saline [154 mmol/l NaCl]) infusion, respectively, with an interposed 7-day washout period. The primary outcome was glycaemic time below range, time in range and time above range.RESULTS: There were no significant differences in time below range (<3.9 mmol/l, p = 0.53) or above range (>10 mmol/l, p = 0.32) during night-time or daytime, in mean glucose, or in hypoglycaemic events as assessed by CGM. GIP altered neither self-reported hypoglycaemia nor safety measures. Compared with placebo, GIP significantly increased time in tight range (3.9-7.8 mmol/l) during daytime (06:00-23:59 hours) by [mean ± SEM] 11.2 ± 5.1% [95% CI 0.41, 21.9] (p = 0.02).CONCLUSIONS/INTERPRETATION: Six-day s.c. GIP infusion in men with type 1 diabetes did not procure convincing effect on overall time in range, but increased time in tight glycaemic range during daytime by ~2 h per day.TRIAL REGISTRATION: ClinicalTrials.gov NCT03734718.FUNDING: The study was funded by grants from The Leona M. and Harry B. Helmsley Charitable Trust and Aase og Ejnar Danielsens Fond.",
keywords = "Adipose tissue, Continuous glucose monitoring, GIP, Glucose-dependent insulinotropic polypeptide, Glycaemic control, Glycaemic time in range, Hypoglycaemia, Hypoglycaemic events, Insulin resistance, Insulin sensitivity",
author = "Heimb{\"u}rger, {Sebastian M N} and Bj{\o}rn Hoe and Nielsen, {Chris N} and Bergmann, {Natasha C} and Bolette Hartmann and Holst, {Jens J} and Tina Vilsb{\o}ll and Dejgaard, {Thomas F} and Christensen, {Mikkel B} and Knop, {Filip K}",
note = "{\textcopyright} 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.",
year = "2021",
month = nov,
doi = "10.1007/s00125-021-05547-8",
language = "English",
volume = "64",
pages = "2425--2431",
journal = "Diabetologia",
issn = "0012-186X",
publisher = "Springer",
number = "11",

}

RIS

TY - JOUR

T1 - The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes

T2 - a randomised, double-blind, placebo-controlled crossover trial

AU - Heimbürger, Sebastian M N

AU - Hoe, Bjørn

AU - Nielsen, Chris N

AU - Bergmann, Natasha C

AU - Hartmann, Bolette

AU - Holst, Jens J

AU - Vilsbøll, Tina

AU - Dejgaard, Thomas F

AU - Christensen, Mikkel B

AU - Knop, Filip K

N1 - © 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

PY - 2021/11

Y1 - 2021/11

N2 - AIMS/HYPOTHESIS: Type 1 diabetes is characterised by reduced glucagon response to hypoglycaemia, increasing the risk of insulin treatment-associated hypoglycaemia known to hamper glycaemic control. We previously reported a glucagonotropic effect of exogenous glucose-dependent insulinotropic polypeptide (GIP) during insulin-induced hypoglycaemia in individuals with type 1 diabetes. Here we investigate the effect of a 6-day s.c. GIP infusion on time in glycaemic range as assessed by continuous glucose monitoring (CGM) in individuals with type 1 diabetes.METHODS: In a randomised, placebo-controlled, double-blind crossover study, time in glycaemic range (assessed by double-blinded CGM) was evaluated in 20 men with type 1 diabetes (18-75 years, stable insulin treatment ≥3 months, diabetes duration 2-15 years, fasting plasma C-peptide below 200 pmol/l, BMI 20-27 kg/m2, HbA1c <69 mmol/mol [8.5%]) during two × 6 days of continuous s.c. GIP (6 pmol kg-1 min-1) and placebo (saline [154 mmol/l NaCl]) infusion, respectively, with an interposed 7-day washout period. The primary outcome was glycaemic time below range, time in range and time above range.RESULTS: There were no significant differences in time below range (<3.9 mmol/l, p = 0.53) or above range (>10 mmol/l, p = 0.32) during night-time or daytime, in mean glucose, or in hypoglycaemic events as assessed by CGM. GIP altered neither self-reported hypoglycaemia nor safety measures. Compared with placebo, GIP significantly increased time in tight range (3.9-7.8 mmol/l) during daytime (06:00-23:59 hours) by [mean ± SEM] 11.2 ± 5.1% [95% CI 0.41, 21.9] (p = 0.02).CONCLUSIONS/INTERPRETATION: Six-day s.c. GIP infusion in men with type 1 diabetes did not procure convincing effect on overall time in range, but increased time in tight glycaemic range during daytime by ~2 h per day.TRIAL REGISTRATION: ClinicalTrials.gov NCT03734718.FUNDING: The study was funded by grants from The Leona M. and Harry B. Helmsley Charitable Trust and Aase og Ejnar Danielsens Fond.

AB - AIMS/HYPOTHESIS: Type 1 diabetes is characterised by reduced glucagon response to hypoglycaemia, increasing the risk of insulin treatment-associated hypoglycaemia known to hamper glycaemic control. We previously reported a glucagonotropic effect of exogenous glucose-dependent insulinotropic polypeptide (GIP) during insulin-induced hypoglycaemia in individuals with type 1 diabetes. Here we investigate the effect of a 6-day s.c. GIP infusion on time in glycaemic range as assessed by continuous glucose monitoring (CGM) in individuals with type 1 diabetes.METHODS: In a randomised, placebo-controlled, double-blind crossover study, time in glycaemic range (assessed by double-blinded CGM) was evaluated in 20 men with type 1 diabetes (18-75 years, stable insulin treatment ≥3 months, diabetes duration 2-15 years, fasting plasma C-peptide below 200 pmol/l, BMI 20-27 kg/m2, HbA1c <69 mmol/mol [8.5%]) during two × 6 days of continuous s.c. GIP (6 pmol kg-1 min-1) and placebo (saline [154 mmol/l NaCl]) infusion, respectively, with an interposed 7-day washout period. The primary outcome was glycaemic time below range, time in range and time above range.RESULTS: There were no significant differences in time below range (<3.9 mmol/l, p = 0.53) or above range (>10 mmol/l, p = 0.32) during night-time or daytime, in mean glucose, or in hypoglycaemic events as assessed by CGM. GIP altered neither self-reported hypoglycaemia nor safety measures. Compared with placebo, GIP significantly increased time in tight range (3.9-7.8 mmol/l) during daytime (06:00-23:59 hours) by [mean ± SEM] 11.2 ± 5.1% [95% CI 0.41, 21.9] (p = 0.02).CONCLUSIONS/INTERPRETATION: Six-day s.c. GIP infusion in men with type 1 diabetes did not procure convincing effect on overall time in range, but increased time in tight glycaemic range during daytime by ~2 h per day.TRIAL REGISTRATION: ClinicalTrials.gov NCT03734718.FUNDING: The study was funded by grants from The Leona M. and Harry B. Helmsley Charitable Trust and Aase og Ejnar Danielsens Fond.

KW - Adipose tissue

KW - Continuous glucose monitoring

KW - GIP

KW - Glucose-dependent insulinotropic polypeptide

KW - Glycaemic control

KW - Glycaemic time in range

KW - Hypoglycaemia

KW - Hypoglycaemic events

KW - Insulin resistance

KW - Insulin sensitivity

UR - http://www.scopus.com/inward/record.url?scp=85112766469&partnerID=8YFLogxK

U2 - 10.1007/s00125-021-05547-8

DO - 10.1007/s00125-021-05547-8

M3 - Journal article

C2 - 34405256

VL - 64

SP - 2425

EP - 2431

JO - Diabetologia

JF - Diabetologia

SN - 0012-186X

IS - 11

ER -

ID: 67560082