StressNCT00740012
Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)
A study testing Continuous glucose monitoring, alarm- clock intervention, patient perform blood glucose self monitoring and nurse intervention in people with Stress and Type 1 Diabetes, run by Diabeteszentrum Bad Lauterberg im Harz at 1 site in Germany.
Trial summary
Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that leads to rising glucose concentrations. The purpose of this study was to prove this hypothesis with continuous glucose monitoring over three nights. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress, Type 1 Diabetes
- What is being tested?
- Continuous glucose monitoring, alarm- clock intervention, patient perform blood glucose self monitoring and nurse intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Sep 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 Diabetic patients (diagnosed longer than 2 years)
- HBA1c 5,0 - 9,5 %
- Age 18-75 years
- Hospitalized patients
- Male or female, if female exclusion of pregnancy or secure contraception
- Body-Mass-Index 19-40 kg/m²
- Patient is elucidated
- Patients agreement
Who cannot join
- Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft
- HbA1c < 5,0 % or > 9,5 %
- A severe hypoglycemia with unconsciousness within the last 2 month
- Body-Mass-Index < 19 or > 40 kg/m²
- No patient agreement
- Pregnancy (positive pregnancy test) or unsecured contraception.
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- Agina pectoris or acute myocardial infarct, as continuous problem
- Inadequate treated arterial hypertension > 160 mmHg systolic and/or < 95 mmHg diastolic
- Active tumor disease
- Anemia hemoglobin < 11,5 g/dl
- Treatment with steroids, sedative or anesthetics
- Infection/fewer > 37.5 °C
- Renal- malfunction (serum- creatinine > 1.5 mg/dl)
- Liver- malfunction (GPT and AP > double of upper- limit)
- Alcohol or drug abuse
- Sleep disorder
- Participation in clinical studies within the last 3 month
- Other significant health dysfunctions, which would affect the outcome of this study
- Incapable to conform the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site
Diabeteszentrum Bad Lauterberg im Harz
Bad Lauterberg im Harz, Lower Saxony, 37431
About this study
Official title: Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)
Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that leads to rising glucose concentrations.
The purpose of this study was to prove this hypothesis with continuous glucose monitoring over three nights.
Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations, and
Night (c) with the patients left undisturbed.
Read the detailed description
To provide nocturnal glucose control in patients with type 1 diabetes is a therapeutic challenge. Nocturnal glucose profiles are an important tool to secure adequate glycemic control during the night. Often, patients are asked to perform self-monitoring with the help of an alarm clock. Such a recommendation depends on the accuracy of glucose concentrations determined this way. We hypothesized that alarm clocks may trigger a stressful arousal that might be accompanied by rises in glucose concentrations, consecutively leading to nocturnal glucose profiles that are not representative for undisturbed conditions.
We want to prove this hypothesis with 30 patients over three nights.
Night (a) with an alarm clock set at 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m) for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations at the 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m), and
Night (c) with the patients left undisturbed.
All the patients are going to use a continuous glucose monitor and half of the patients (uneven numbers) are going to have an indwelling venous cannula during night (a) and (b.
During night (a) and (b) 5-7 minutes after the scheduled times for glucose measurements the doctoral candidate is going to take the pulse, another capillary blood sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany). Also the doctoral candidate is going to take a venous blood sample in half of the patients (uneven numbers), blood from the indwelling venous cannula for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany).
- Conditions
- Stress, Type 1 Diabetes
- Being tested
- Continuous glucose monitoring, alarm- clock intervention, patient perform blood glucose self monitoring, nurse intervention, Taking the patients pulse, Venous blood drawing
- Keywords
- Nocturnal glucose profiles, continuous glucose profiles
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringOther
Also called Gluco Day S (Menarini Diagnostics)
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
alarm- clock intervention, patient perform blood glucose self monitoringOther
Also called Ordinary alarm clock
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
nurse interventionOther
Also called professional night nurses
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Taking the patients pulseOther
Also called Pulse measurment
In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.
Venous blood drawingOther
Also called venous blood drawing from an intravenous catheter
Venous blood drawing for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany) (6-10 minutes after midnight, 2 a.m., 4 a.m. and 6:45 a.m.)in night (a) and (b)
Other capillary sampleOther
Also called laboratory method (EBIOS, Eppendorf, Hamburg, Germany)
5-7 minutes after the alarm clock or the nurse the doctoral candidate takes another capillary sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany) analyzer.
| Study group | Role | What they receive |
|---|---|---|
| Even, low numbers | Active comparator | They start with a alarm- clock night. No venous blood drawing. Receives: Other: Continuous glucose monitoring; Other: alarm- clock intervention, patient perform blood glucose self monitoring; Other: nurse intervention; Other: Taking the patients pulse; Other: Other capillary sample |
| Even, high numbers | Active comparator | They start with a nurse performing blood glucose determination. No venous blood drawing. Receives: Other: Continuous glucose monitoring; Other: alarm- clock intervention, patient perform blood glucose self monitoring; Other: nurse intervention; Other: Taking the patients pulse; Other: Other capillary sample |
| Uneven, low numbers | Active comparator | They start with an alarm- clock night and have venous blood drawing. Receives: Other: Continuous glucose monitoring; Other: alarm- clock intervention, patient perform blood glucose self monitoring; Other: nurse intervention; Other: Taking the patients pulse; Other: Venous blood drawing; Other: Other capillary sample |
| Uneven, high numbers | Active comparator | They start with a nurse performing blood glucose determination and have venous blood drawing. Receives: Other: Continuous glucose monitoring; Other: alarm- clock intervention, patient perform blood glucose self monitoring; Other: nurse intervention; Other: Taking the patients pulse; Other: Venous blood drawing; Other: Other capillary sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose (continuous glucose monitoring)
Measured: 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights
Secondary outcomes (1)
Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose
Measured: 22 pm, midnight, 2 am, 4 am, 6:45 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startMar 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabeteszentrum Bad Lauterberg im Harz
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin-Chemie Menarini
- Investigators
- Michael A. Nauck, professor, Principal investigator, Diabeteszentrum Bad Lauterberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740012
- Sponsor's protocol ID
- Glucoday BL
- Status last verified
- Sep 2008
- First submitted
- 20 Aug 2008
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Berndt C, Köthe L, Nawrodt B, Mraz B, Patzelt-Bath A. Glycaemic rises after waking up in response to an alarm clock during the night in type 1 diabetic patients can be avoided by experienced nurses drawing blood in a hospital setting as shown by continuous glucose monitoring (GlucoDayR) (abstract 14). Diabetologia 51 (Suppl. 1): S 12
Berndt-Zipfel C, Kothe L, Nawrodt B, Mraz B, Patzelt-Bath A, Nauck MA. Glycaemic rises after waking up in response to an alarm clock in type 1-diabetic patients analysed with continuous glucose monitoring (GlucoDay(R) S). Exp Clin Endocrinol Diabetes. 2011 Jan;119(1):56-8. doi: 10.1055/s-0030-1265162. Epub 2011 Jan 18.
PubMed 21246465
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)
- ClinicalTrials.gov ID
- NCT00740012
- Acronym / sponsor ID
- Glucoday BL
- Conditions
- Stress, Type 1 Diabetes
- Keywords
- Nocturnal glucose profiles, continuous glucose profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Diabeteszentrum Bad Lauterberg im HarzUniversity, hospital or other
- Collaborators
- Berlin-Chemie Menarini
- Study start
- Mar 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Aug 2008 (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.
Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that leads to rising glucose concentrations.
The purpose of this study was to prove this hypothesis with continuous glucose monitoring over three nights.
Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations, and
Night (c) with the patients left undisturbed.
Detailed description
To provide nocturnal glucose control in patients with type 1 diabetes is a therapeutic challenge. Nocturnal glucose profiles are an important tool to secure adequate glycemic control during the night. Often, patients are asked to perform self-monitoring with the help of an alarm clock. Such a recommendation depends on the accuracy of glucose concentrations determined this way. We hypothesized that alarm clocks may trigger a stressful arousal that might be accompanied by rises in glucose concentrations, consecutively leading to nocturnal glucose profiles that are not representative for undisturbed conditions.
We want to prove this hypothesis with 30 patients over three nights.
Night (a) with an alarm clock set at 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m) for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations at the 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m), and
Night (c) with the patients left undisturbed.
All the patients are going to use a continuous glucose monitor and half of the patients (uneven numbers) are going to have an indwelling venous cannula during night (a) and (b.
During night (a) and (b) 5-7 minutes after the scheduled times for glucose measurements the doctoral candidate is going to take the pulse, another capillary blood sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany). Also the doctoral candidate is going to take a venous blood sample in half of the patients (uneven numbers), blood from the indwelling venous cannula for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Even, low numbers | Active comparator | Other: Continuous glucose monitoring, Other: alarm- clock intervention, patient perform blood glucose self monitoring, Other: nurse intervention, Other: Taking the patients pulse, Other: Other capillary sampleThey start with a alarm- clock night. No venous blood drawing. |
| Even, high numbers | Active comparator | Other: Continuous glucose monitoring, Other: alarm- clock intervention, patient perform blood glucose self monitoring, Other: nurse intervention, Other: Taking the patients pulse, Other: Other capillary sampleThey start with a nurse performing blood glucose determination. No venous blood drawing. |
| Uneven, low numbers | Active comparator | Other: Continuous glucose monitoring, Other: alarm- clock intervention, patient perform blood glucose self monitoring, Other: nurse intervention, Other: Taking the patients pulse, Other: Venous blood drawing, Other: Other capillary sampleThey start with an alarm- clock night and have venous blood drawing. |
| Uneven, high numbers | Active comparator | Other: Continuous glucose monitoring, Other: alarm- clock intervention, patient perform blood glucose self monitoring, Other: nurse intervention, Other: Taking the patients pulse, Other: Venous blood drawing, Other: Other capillary sampleThey start with a nurse performing blood glucose determination and have venous blood drawing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 Diabetic patients (diagnosed longer than 2 years)
- HBA1c 5,0 - 9,5 %
- Age 18-75 years
- Hospitalized patients
- Male or female, if female exclusion of pregnancy or secure contraception
Key exclusion criteria (19 listed)
- Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft
- HbA1c < 5,0 % or > 9,5 %
- A severe hypoglycemia with unconsciousness within the last 2 month
- Body-Mass-Index < 19 or > 40 kg/m²
- No patient agreement
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 |
|---|---|---|
| Continuous glucose monitoringAlso: Gluco Day S (Menarini Diagnostics)Glucoday S (microdialysis system). Continuous glucose monitoring all three nights | Other | Even, high numbers, Even, low numbers, Uneven, high numbers, Uneven, low numbers |
| alarm- clock intervention, patient perform blood glucose self monitoringAlso: Ordinary alarm clockAlarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m. | Other | Even, high numbers, Even, low numbers, Uneven, high numbers, Uneven, low numbers |
| nurse interventionAlso: professional night nursesNurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. . | Other | Even, high numbers, Even, low numbers, Uneven, high numbers, Uneven, low numbers |
| Taking the patients pulseAlso: Pulse measurmentIn nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse. | Other | Even, high numbers, Even, low numbers, Uneven, high numbers, Uneven, low numbers |
| Venous blood drawingAlso: venous blood drawing from an intravenous catheterVenous blood drawing for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany) (6-10 minutes after midnight, 2 a.m., 4 a.m. and 6:45 a.m.)in night (a) and (b) | Other | Uneven, high numbers, Uneven, low numbers |
| Other capillary sampleAlso: laboratory method (EBIOS, Eppendorf, Hamburg, Germany)5-7 minutes after the alarm clock or the nurse the doctoral candidate takes another capillary sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany) analyzer. | Other | Even, high numbers, Even, low numbers, Uneven, high numbers, Uneven, low numbers |
Primary outcome
Glucose (continuous glucose monitoring)
Time frame: 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights
1 secondary outcome
Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose
Time frame: 22 pm, midnight, 2 am, 4 am, 6:45 am
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2008.
- Results publicationBerndt C, Köthe L, Nawrodt B, Mraz B, Patzelt-Bath A. Glycaemic rises after waking up in response to an alarm clock during the night in type 1 diabetic patients can be avoided by experienced nurses drawing blood in a hospital setting as shown by continuous glucose monitoring (GlucoDayR) (abstract 14). Diabetologia 51 (Suppl. 1): S 12
- Derived from this study: PubMed 21246465Berndt-Zipfel C, Kothe L, Nawrodt B, Mraz B, Patzelt-Bath A, Nauck MA. Glycaemic rises after waking up in response to an alarm clock in type 1-diabetic patients analysed with continuous glucose monitoring (GlucoDay(R) S). Exp Clin Endocrinol Diabetes. 2011 Jan;119(1):56-8. doi: 10.1055/s-0030-1265162. Epub 2011 Jan 18.
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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.
Michael A. Nauck, professor principal investigator
Diabeteszentrum Bad Lauterberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring, alarm- clock intervention, patient perform blood glucose self monitoring and nurse intervention in people with Stress and Type 1 Diabetes, run by Diabeteszentrum Bad Lauterberg im Harz 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 29 Sep 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose (continuous glucose monitoring) (time frame: 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights). 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 NCT00740012, which also lists 2 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 29 Sep 2008.