Type 1 DiabetesNCT02871180
Late Night Snack and Insulin Glargine
A study testing Late night snack and No late night snack in people with Type 1 Diabetes and Hypoglycemia, run by Diabeteszentrum Bad Lauterberg im Harz at 1 site in Germany.
Trial summary
Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Late night snack and No late night snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Basal insulin substitution with insulin glargine at least 3 month
Who cannot join
- Severe disorders
- Severe and clinical significant gastroparesis
- History of pancreatitis or pancreatic cancer
- Severe Liver disorder (liver enzymes > three times upper normal limit)
- Pregnancy
- Drug- or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Diabeteszentrum Bad Lauterberg
Bad Lauterberg im Harz, Lower Saxony, 37431
About this study
Official title: A Late Night Snack May be Necessary to Prevent Nocturnal Hyperglycemia in Type 1-diabetic Patients Using Insulin Glargine (LANTUS)
Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.
Read the detailed description
The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Late night snack, No late night snack
- Keywords
- Hypoglycemia, Type 1 diabetes
- 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.
Late night snackDietary supplement
The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.
No late night snackOther
Patient consumed no nutrients at late night.
| Study group | Role | What they receive |
|---|---|---|
| With late night snack | Other | At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten from Type 1 diabetic patients on an intensified conventional treatment regimen. Receives: Dietary Supplement: Late night snack |
| Without late night snack | Other | Not nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen.. Receives: Other: No late night snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method
Measured: 26 hours
Secondary outcomes (1)
Blood glucose profile
The blood glucose profile with and without a late-night snack . (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day).
Measured: 26 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startMar 2003
- Primary completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabeteszentrum Bad Lauterberg im Harz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
- Investigators
- Michael A. Nauck, Prof., Principal investigator, St. Josef-Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871180
- Sponsor's protocol ID
- Late night snack & Lantus
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Late Night Snack May be Necessary to Prevent Nocturnal Hyperglycemia in Type 1-diabetic Patients Using Insulin Glargine (LANTUS)
- ClinicalTrials.gov ID
- NCT02871180
- Acronym / sponsor ID
- Late night snack & Lantus
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Hypoglycemia, Type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Diabeteszentrum Bad Lauterberg im HarzUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Aug 2016 (actual)
- First posted
- 18 Aug 2016 (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.
Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.
Detailed description
The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With late night snack | Other | Dietary Supplement: Late night snackAt 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten from Type 1 diabetic patients on an intensified conventional treatment regimen. |
| Without late night snack | Other | Other: No late night snackNot nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen.. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Basal insulin substitution with insulin glargine at least 3 month
Key exclusion criteria (6 listed)
- Severe disorders
- Severe and clinical significant gastroparesis
- History of pancreatitis or pancreatic cancer
- Severe Liver disorder (liver enzymes > three times upper normal limit)
- Pregnancy
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 |
|---|---|---|
| Late night snackThe late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate. | Dietary supplement | With late night snack |
| No late night snackPatient consumed no nutrients at late night. | Other | Without late night snack |
Primary outcome
Hypoglycemia
Time frame: 26 hours
Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method
1 secondary outcome
Blood glucose profile
Time frame: 26 hours
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 18 Aug 2016.
- 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.
Michael A. Nauck, Prof. principal investigator
St. Josef-Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Late night snack and No late night snack in people with Type 1 Diabetes and Hypoglycemia, 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 2 inclusion and 6 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 18 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 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?
Hypoglycemia (time frame: 26 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2016.