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unexpected low willingness of patient to participate on the study
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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
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The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.
Participants will get two times a height, weight an gender based amount of beer.
One time (Standard) there will be no Insulin given for the beer. Second time (Intervention) half of the carbohydrates containing in the beer will be covered with Insulin, additionally the basal rate will be set to 50% for 12 hours.
All the time, Glucose will be monitored by continuous subcutaneous Glucose Monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | For carbohydrates in beer, subjects will get covering by Insulin (1/2 of calculated amount). As well Insulin basal rate will set to half for 12 hours |
|
| Standard | No Intervention | No Insulin Treatment of carbohydrates in beer. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Insulin for beer |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am) | 18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day | 18 hours | |
| • Total Area under the curve | 18 hours | |
| • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben Biester, MD | Study Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinder - und Jugendkrankenhaus AUF DER BULT | Hanover | 30173 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5774487 | Background | Krebs HA, Freedland RA, Hems R, Stubbs M. Inhibition of hepatic gluconeogenesis by ethanol. Biochem J. 1969 Mar;112(1):117-24. doi: 10.1042/bj1120117. | |
| 11679452 | Background | Turner BC, Jenkins E, Kerr D, Sherwin RS, Cavan DA. The effect of evening alcohol consumption on next-morning glucose control in type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1888-93. doi: 10.2337/diacare.24.11.1888. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 18 hours |
| • Time from end of consumption to nadir of serum glucose |
| • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch | 18 hours |
| • Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch | 18 hours |
| • Time in Hypoglycaemia <70 mg/dl per treatment arm | 18 hours |
| • Max. alcohol in expiratory breath | 3 hours |
| 1499475 | Background | Gin H, Morlat P, Ragnaud JM, Aubertin J. Short-term effect of red wine (consumed during meals) on insulin requirement and glucose tolerance in diabetic patients. Diabetes Care. 1992 Apr;15(4):546-8. doi: 10.2337/diacare.15.4.546. |
| Background | Jennifer F. Scheel, Karin Schielke, Stefan Lautenbacher, Sabine Aust1, Simone Kremer, Jörg Wolstein; Low-Dose Alcohol Effects on Attention in Adolescents, Zeitschrift für Neuropsychologie, 24 (2), 2013, 103 - 111 |
| 8299457 | Background | Koivisto VA, Tulokas S, Toivonen M, Haapa E, Pelkonen R. Alcohol with a meal has no adverse effects on postprandial glucose homeostasis in diabetic patients. Diabetes Care. 1993 Dec;16(12):1612-4. doi: 10.2337/diacare.16.12.1612. |
| 11197633 | Background | Seidl S, Jensen U, Alt A. The calculation of blood ethanol concentrations in males and females. Int J Legal Med. 2000;114(1-2):71-7. doi: 10.1007/s004140000154. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |