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Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial.
CMAJ. 2013 Mar 05; 185(4):297-305.CMAJ

Abstract

BACKGROUND

Most patients with type 1 diabetes do not achieve their glycemic targets. We aimed to assess the efficacy of glucose-responsive insulin and glucagon closed-loop delivery for controlling glucose levels in adults with type 1 diabetes.

METHODS

We conducted a randomized crossover trial involving 15 adults with type 1 diabetes, comparing standard insulin-pump therapy with dual-hormone, closed-loop delivery. Patients were admitted twice to a clinical research facility and received, in random order, both treatments. Each 15-hour visit (from 1600 to 0700) included an evening exercise session, followed by a medium-sized meal, a bedtime snack and an overnight stay. During visits that involved closed-loop delivery, basal insulin and glucagon miniboluses were delivered according to recommendations based on glucose sensor readings and a predictive dosing algorithm at 10-minute intervals. During visits involving standard insulin-pump therapy (control visits), patients used conventional treatment.

RESULTS

Dual-hormone closed-loop delivery increased the percentage of time for which patients' plasma glucose levels were in the target range (median 70.7% [interquartile range (IQR) 46.1%-88.4%] for closed-loop delivery v. 57.3% [IQR 25.2%-71.8%] for control, p = 0.003) and decreased the percentage of time for which plasma glucose levels were in the low range (bottom of target range [< 4.0 mmol/L], 0.0% [IQR 0.0%-3.0%] for closed-loop delivery v. 10.2% [IQR 0.0%-13.0%] for control, p = 0.01; hypoglycemia threshold [< 3.3 mmol/L], 0.0% [IQR 0.0%-0.0%] for closed-loop delivery v. 2.8% [IQR 0.0%-5.9%] for control, p = 0.006). Eight participants (53%) had at least 1 hypoglycemic event (plasma glucose < 3.0 mmol/L) during standard treatment, compared with just 1 participant (7%) during closed-loop treatment (p = 0.02).

INTERPRETATION

Dual-hormone, closed-loop delivery guided by advanced algorithms improved short-term glucose control and reduced the risk of hypoglycemia in a group of 15 adults with type 1 diabetes.

TRIAL REGISTRATION

ClinicalTrials.gov, no. NCT01297946.

Authors+Show Affiliations

Institut de Recherches Cliniques de Montréal, Montréal, Que. ahmad.haidar@mail.mcgillNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23359039

Citation

Haidar, Ahmad, et al. "Glucose-responsive Insulin and Glucagon Delivery (dual-hormone Artificial Pancreas) in Adults With Type 1 Diabetes: a Randomized Crossover Controlled Trial." CMAJ : Canadian Medical Association Journal = Journal De l'Association Medicale Canadienne, vol. 185, no. 4, 2013, pp. 297-305.
Haidar A, Legault L, Dallaire M, et al. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ. 2013;185(4):297-305.
Haidar, A., Legault, L., Dallaire, M., Alkhateeb, A., Coriati, A., Messier, V., Cheng, P., Millette, M., Boulet, B., & Rabasa-Lhoret, R. (2013). Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ : Canadian Medical Association Journal = Journal De l'Association Medicale Canadienne, 185(4), 297-305. https://doi.org/10.1503/cmaj.121265
Haidar A, et al. Glucose-responsive Insulin and Glucagon Delivery (dual-hormone Artificial Pancreas) in Adults With Type 1 Diabetes: a Randomized Crossover Controlled Trial. CMAJ. 2013 Mar 5;185(4):297-305. PubMed PMID: 23359039.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. AU - Haidar,Ahmad, AU - Legault,Laurent, AU - Dallaire,Maryse, AU - Alkhateeb,Ammar, AU - Coriati,Adèle, AU - Messier,Virginie, AU - Cheng,Peiyao, AU - Millette,Maude, AU - Boulet,Benoit, AU - Rabasa-Lhoret,Rémi, Y1 - 2013/01/28/ PY - 2013/1/30/entrez PY - 2013/1/30/pubmed PY - 2013/4/23/medline SP - 297 EP - 305 JF - CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne JO - CMAJ VL - 185 IS - 4 N2 - BACKGROUND: Most patients with type 1 diabetes do not achieve their glycemic targets. We aimed to assess the efficacy of glucose-responsive insulin and glucagon closed-loop delivery for controlling glucose levels in adults with type 1 diabetes. METHODS: We conducted a randomized crossover trial involving 15 adults with type 1 diabetes, comparing standard insulin-pump therapy with dual-hormone, closed-loop delivery. Patients were admitted twice to a clinical research facility and received, in random order, both treatments. Each 15-hour visit (from 1600 to 0700) included an evening exercise session, followed by a medium-sized meal, a bedtime snack and an overnight stay. During visits that involved closed-loop delivery, basal insulin and glucagon miniboluses were delivered according to recommendations based on glucose sensor readings and a predictive dosing algorithm at 10-minute intervals. During visits involving standard insulin-pump therapy (control visits), patients used conventional treatment. RESULTS: Dual-hormone closed-loop delivery increased the percentage of time for which patients' plasma glucose levels were in the target range (median 70.7% [interquartile range (IQR) 46.1%-88.4%] for closed-loop delivery v. 57.3% [IQR 25.2%-71.8%] for control, p = 0.003) and decreased the percentage of time for which plasma glucose levels were in the low range (bottom of target range [< 4.0 mmol/L], 0.0% [IQR 0.0%-3.0%] for closed-loop delivery v. 10.2% [IQR 0.0%-13.0%] for control, p = 0.01; hypoglycemia threshold [< 3.3 mmol/L], 0.0% [IQR 0.0%-0.0%] for closed-loop delivery v. 2.8% [IQR 0.0%-5.9%] for control, p = 0.006). Eight participants (53%) had at least 1 hypoglycemic event (plasma glucose < 3.0 mmol/L) during standard treatment, compared with just 1 participant (7%) during closed-loop treatment (p = 0.02). INTERPRETATION: Dual-hormone, closed-loop delivery guided by advanced algorithms improved short-term glucose control and reduced the risk of hypoglycemia in a group of 15 adults with type 1 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01297946. SN - 1488-2329 UR - https://www.unboundmedicine.com/medline/citation/23359039/Glucose_responsive_insulin_and_glucagon_delivery__dual_hormone_artificial_pancreas__in_adults_with_type_1_diabetes:_a_randomized_crossover_controlled_trial_ L2 - http://www.cmaj.ca/cgi/pmidlookup?view=long&amp;pmid=23359039 DB - PRIME DP - Unbound Medicine ER -