Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial.
Journal
The lancet. Diabetes & endocrinology
ISSN: 2213-8595
Titre abrégé: Lancet Diabetes Endocrinol
Pays: England
ID NLM: 101618821
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
received:
02
02
2019
revised:
01
04
2019
accepted:
02
04
2019
pubmed:
3
5
2019
medline:
23
5
2020
entrez:
4
5
2019
Statut:
ppublish
Résumé
Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect -2·9 [95% CI -3·5 to -2·3]; p<0·0001) and fewer severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall (three vs 18; p=0·0036). The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76). No serious adverse device effects or episodes of diabetic ketoacidosis were reported. Insulin pump therapy with integrated CGM and a suspend-before-low feature reduced the frequency of sensor hypoglycaemic and severe hypoglycaemic events in hypoglycaemia-prone adults compared with use of continuous subcutaneous insulin infusion without real-time CGM. These results suggest that this technology could be beneficial in this high-risk population. Medtronic International Trading Sàrl and Medtronic Canada.
Sections du résumé
BACKGROUND
Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes.
METHODS
SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA
FINDINGS
Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect -2·9 [95% CI -3·5 to -2·3]; p<0·0001) and fewer severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall (three vs 18; p=0·0036). The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76). No serious adverse device effects or episodes of diabetic ketoacidosis were reported.
INTERPRETATION
Insulin pump therapy with integrated CGM and a suspend-before-low feature reduced the frequency of sensor hypoglycaemic and severe hypoglycaemic events in hypoglycaemia-prone adults compared with use of continuous subcutaneous insulin infusion without real-time CGM. These results suggest that this technology could be beneficial in this high-risk population.
FUNDING
Medtronic International Trading Sàrl and Medtronic Canada.
Identifiants
pubmed: 31047902
pii: S2213-8587(19)30150-0
doi: 10.1016/S2213-8587(19)30150-0
pii:
doi:
Substances chimiques
Hypoglycemic Agents
0
Insulin
0
Banques de données
ClinicalTrials.gov
['NCT02733991']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
462-472Investigateurs
Andrea Laurenzi
(A)
Amelia Caretto
(A)
David Slatterly
(D)
Marcia Henderson-Wilson
(M)
S John Weisnagel
(SJ)
Marie-Christine Dubé
(MC)
Valérie-Ève Julien
(VÈ)
Roberto Trevisan
(R)
Giuseppe Lepore
(G)
Rosalia Bellante
(R)
Irene Hramiak
(I)
Tamara Spaic
(T)
Marsha Driscoll
(M)
Sophie Borot
(S)
Annie Clergeot
(A)
Lamia Khiat
(L)
Peter Hammond
(P)
Sutapa Ray
(S)
Laura Dinning
(L)
Giancarlo Tonolo
(G)
Alberto Manconi
(A)
Maura Serena Ledda
(MS)
Wendela de Ranitz
(W)
Bianca Silvius
(B)
Anne Wojtusciszyn
(A)
Anne Farret
(A)
Titia Vriesendorp
(T)
Folkje Immeker-de Jong
(F)
Joke van der Linden
(J)
Huguette S Brink
(HS)
Marije Alkemade
(M)
Pauline Schaepelynck-Belicar
(P)
Sébastien Galie
(S)
Clémence Tréglia
(C)
Pierre-Yves Benhamou
(PY)
Myriam Haddouche
(M)
Roel Hoogma
(R)
Lalantha Leelarathna
(L)
Angel Shaju
(A)
Linda James
(L)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
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