Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp
This randomized, crossover trial compared an artificial-pancreas system with a sensor-augmented pump for nocturnal glucose control in young persons with type 1 diabetes at a diabetes camp. The artificial pancreas resulted in less hypoglycemia and tighter glucose control. Intensive insulin therapy is...
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| Vydané v: | The New England journal of medicine Ročník 368; číslo 9; s. 824 - 833 |
|---|---|
| Hlavní autori: | , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
Waltham, MA
Massachusetts Medical Society
28.02.2013
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| Predmet: | |
| ISSN: | 0028-4793, 1533-4406, 1533-4406 |
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| Abstract | This randomized, crossover trial compared an artificial-pancreas system with a sensor-augmented pump for nocturnal glucose control in young persons with type 1 diabetes at a diabetes camp. The artificial pancreas resulted in less hypoglycemia and tighter glucose control.
Intensive insulin therapy is considered to be the standard treatment for tight blood glucose control in patients with type 1 diabetes, since it prevents long-term complications. Several studies have promoted the use of insulin pumps, glucose sensors, or a combination of the two devices (sensor-augmented pump)
1
–
3
to improve glucose control. However, the risk of hypoglycemia is still present with the use of all currently available therapies.
4
–
6
Maintenance of nocturnal euglycemia is extremely important and is challenging, since most cases of severe hypoglycemia occur at night.
7
,
8
Such episodes account for 75% of total hypoglycemic seizures in children
9
and . . . |
|---|---|
| AbstractList | Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.
In this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients.
On nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported.
Patients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; ClinicalTrials.gov number, NCT01238406.). BackgroundRecent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.MethodsIn this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients.ResultsOn nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported.ConclusionsPatients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; ClinicalTrials.gov number, NCT01238406.) Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.BACKGROUNDRecent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.In this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients.METHODSIn this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients.On nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported.RESULTSOn nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported.Patients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; ClinicalTrials.gov number, NCT01238406.).CONCLUSIONSPatients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; ClinicalTrials.gov number, NCT01238406.). This randomized, crossover trial compared an artificial-pancreas system with a sensor-augmented pump for nocturnal glucose control in young persons with type 1 diabetes at a diabetes camp. The artificial pancreas resulted in less hypoglycemia and tighter glucose control. Intensive insulin therapy is considered to be the standard treatment for tight blood glucose control in patients with type 1 diabetes, since it prevents long-term complications. Several studies have promoted the use of insulin pumps, glucose sensors, or a combination of the two devices (sensor-augmented pump) 1 – 3 to improve glucose control. However, the risk of hypoglycemia is still present with the use of all currently available therapies. 4 – 6 Maintenance of nocturnal euglycemia is extremely important and is challenging, since most cases of severe hypoglycemia occur at night. 7 , 8 Such episodes account for 75% of total hypoglycemic seizures in children 9 and . . . |
| Author | Kordonouri, Olga Nimri, Revital Danne, Thomas Miller, Shahar Phillip, Moshe Battelino, Tadej Atlas, Eran Avbelj Stefanija, Magdalena Muller, Ido Biester, Torben Bratina, Natasa |
| Author_xml | – sequence: 1 givenname: Moshe surname: Phillip fullname: Phillip, Moshe organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 2 givenname: Tadej surname: Battelino fullname: Battelino, Tadej organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 3 givenname: Eran surname: Atlas fullname: Atlas, Eran organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 4 givenname: Olga surname: Kordonouri fullname: Kordonouri, Olga organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 5 givenname: Natasa surname: Bratina fullname: Bratina, Natasa organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 6 givenname: Shahar surname: Miller fullname: Miller, Shahar organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 7 givenname: Torben surname: Biester fullname: Biester, Torben organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 8 givenname: Magdalena surname: Avbelj Stefanija fullname: Avbelj Stefanija, Magdalena organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 9 givenname: Ido surname: Muller fullname: Muller, Ido organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 10 givenname: Revital surname: Nimri fullname: Nimri, Revital organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) – sequence: 11 givenname: Thomas surname: Danne fullname: Danne, Thomas organization: From the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva (M.P., E.A., S.M., I.M., R.N.), and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (M.P.) — both in Israel; the Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia (T. Battelino, N.B., M.A.S.); and the Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany (O.K., T. Biester, T.D.) |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27040421$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23445093$$D View this record in MEDLINE/PubMed |
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| Snippet | This randomized, crossover trial compared an artificial-pancreas system with a sensor-augmented pump for nocturnal glucose control in young persons with type 1... Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether... BackgroundRecent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known... |
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| SubjectTerms | Adolescent Automation Biological and medical sciences Blood Glucose Calibration Camping Carbohydrates Child Control algorithms Cross-Over Studies Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) Diabetes Mellitus, Type 1 - blood Diabetes Mellitus, Type 1 - therapy Diabetes. Impaired glucose tolerance Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female General aspects Glucose Glycated Hemoglobin A - analysis Humans Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - prevention & control Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Insulin - adverse effects Insulin - therapeutic use Insulin Infusion Systems - adverse effects Male Meals Medical sciences Pancreas Pancreas, Artificial - adverse effects Patients Sensors Software |
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| Title | Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp |
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