Type 1 Diabetes MellitusBEERNCT02518022
How to be Safe With Alcoholic Drinks in Diabetes
A study testing Insulin in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypoglycemia
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent by participants
- Signed informed consent by parent or legal guardian of adolescent participants <18 years of age
- Age between16-21 years (both including)
- >1 year Type 1 Diabetes
- continuous subcutaneous insulin infusion for at least 3 months
- HbA1c 7-10 % (both including)
Show all 9Show fewer
- BMI between10-95th percentile for gender and age (both including) for adolescents, <95th percentile for adults
- Ability to wear glucose sensor
- Normal liver enzymes (alanine aminotransferase , aspartate transaminase , Gamma-Glutamyl-Transferase, bilirubin) in age appropriate range by local lab
Who cannot join
- Severe hypoglycaemia or diabetic ketoacidosis in the past 6 month
- Alcohol or drug abuse
- Psychiatric disorder
- Unstable other metabolic disease as judged by investigator
- Intake of glucocorticoids or growth hormone
- Allergy to adhesive
- Coeliac disease
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocentric, Controlled, Randomized, Open-label Cross-over Study to Explore the Possible Insulin Treatment of Beverages Containing Alcohol and Carbohydrates in Adolescents and Young Adults With Type 1 Diabetes
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.
Read the detailed description
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.
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia
- Being tested
- Insulin
- Keywords
- Type 1 Diabetes mellitus, Hypoglycemia, continuous subcutaneous insulin infusion, Alcohol, continuous glucose monitoring system, Nutrition
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Novorapid or Humalog
Insulin for beer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Insulin |
| Standard | No intervention | No Insulin Treatment of carbohydrates in beer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)
Measured: 18 hours
Secondary outcomes (8)
• Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day
Measured: 18 hours
• Total Area under the curve
Measured: 18 hours
• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day
Measured: 18 hours
• Time from end of consumption to nadir of serum glucose
• Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch
Measured: 18 hours
• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch
Measured: 18 hours
• Time in Hypoglycaemia <70 mg/dl per treatment arm
Measured: 18 hours
• Max. alcohol in expiratory breath
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: unexpected low willingness of patient to participate on the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Torben Biester, MD, Principal investigator, Study Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518022
- Sponsor's protocol ID
- BEER2015
- Acronym
- BEER
- Status last verified
- Aug 2016
- First submitted
- 22 May 2015
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 5774487Turner 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.
PubMed 11679452Gin 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.
PubMed 1499475Jennifer 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
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.
PubMed 8299457Seidl 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.
PubMed 11197633
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Controlled, Randomized, Open-label Cross-over Study to Explore the Possible Insulin Treatment of Beverages Containing Alcohol and Carbohydrates in Adolescents and Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02518022
- Acronym / sponsor ID
- BEER / BEER2015
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia
- Keywords
- Type 1 Diabetes mellitus, Hypoglycemia, continuous subcutaneous insulin infusion, Alcohol, continuous glucose monitoring system, Nutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unexpected low willingness of patient to participate on the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: InsulinFor 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. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Signed informed consent by participants
- Signed informed consent by parent or legal guardian of adolescent participants <18 years of age
- Age between16-21 years (both including)
- >1 year Type 1 Diabetes
- continuous subcutaneous insulin infusion for at least 3 months
Key exclusion criteria (8 listed)
- Severe hypoglycaemia or diabetic ketoacidosis in the past 6 month
- Alcohol or drug abuse
- Psychiatric disorder
- Unstable other metabolic disease as judged by investigator
- Intake of glucocorticoids or growth hormone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinAlso: Novorapid or HumalogInsulin for beer | Drug | Intervention |
Primary outcome
• Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)
Time frame: 18 hours
8 secondary outcomes
• Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day
Time frame: 18 hours
• Total Area under the curve
Time frame: 18 hours
• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day
Time frame: 18 hours
• Time from end of consumption to nadir of serum glucose
• Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch
Time frame: 18 hours
• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch
Time frame: 18 hours
• Time in Hypoglycaemia <70 mg/dl per treatment arm
Time frame: 18 hours
• Max. alcohol in expiratory breath
Time frame: 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 5774487Krebs 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.
- Background: PubMed 11679452Turner 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.
- Background: PubMed 1499475Gin 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.
- BackgroundJennifer 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
- Background: PubMed 8299457Koivisto 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.
- Background: PubMed 11197633Seidl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Biester, MD principal investigator
Study Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am) (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518022, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.