Type 1 Diabetes MellitusNCT00475345
Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia
A study testing Bedtime snacks in people with Type 1 Diabetes Mellitus, run by McGill University at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether or not bedtime snacks are necessary to prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1 diabetes who are using intensive insulin therapies, either multiple injections of insulin or insulin pump. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Bedtime snacks
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2000to Sep 2001
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with type 1 diabetes for more than 3 years duration and on intensive insulin therapy using multiple daily injections of insulin (MDI) for at least 1 year prior to study.
Who cannot join
- Pregnant women or intending to become pregnant in next year,
- Significant hepatic or renal disease,
- Active cancer,
- Abuse of alcohol or drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia in Adults With Type 1 Diabetes Undergoing Intensive Management
The purpose of this study is to determine whether or not bedtime snacks are necessary to prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1 diabetes who are using intensive insulin therapies, either multiple injections of insulin or insulin pump.
We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well adjusted and delivered, especially by use of insulin pump which is considered the "gold standard" for overnight blood glucose control.
Read the detailed description
Nocturnal hypoglycemia is a significant side effect of insulin replacement therapy and can lead to many problems including coma and death in the most extreme cases and deterioration of glycemic control. Strategies to prevent nocturnal hypoglycemia include development of newer insulins and delivery systems and the use of specific bedtime snack compositions. Detection of nocturnal hypoglycemia, as it occurs in everyday life, has been a problem since most episodes go unnoticed and therefore untreated leading to a very dangerous situation. With the recent availability of technology which allows for continuous glucose monitoring , it has been made possible to detect nocturnal hypoglycemia as it occurs in daily life. As well, this technology allows for the possibility of better titration of therapy.
Therefore, the goal of our study was to use continuous glucose monitoring technology as a tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia as it occurs in daily life. Specifically, we sought to compare the use of insulin pump therapy with no bedtime snacks and using a new type of insulin called an analogue(lispro) versus multiple daily injections of insulin, using the same type of insulin analogue, and with and without bedtime snacks. Therefore, we compared 3 groups: 1) insulin pump with no bedtime snacks; 2) multiple injections with bedtime snacks and 3) multiple injections with no bedtime snacks. The groups were primarily compared for the occurrence and frequency of nocturnal hypoglycemia. Other comparisons included: long term glycemic control (A1c), weight and body composition and quality of life.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Bedtime snacks
- Keywords
- Nocturnal hypoglycemia, Bedtime snacks, Continuous glucose monitoring, Continuous subcutaneous insulin infusion, CSII, Intensive therapy
- 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.
Bedtime snacksBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nocturnal hypoglycemia (< 4mmol/L) occurring between 11pm and 7am, as determined with the Continuous Glucose Monitoring System (CGMS) and hemoglobin A1c
Measured: end of 3 months for each group
Secondary outcomes (1)
Nadir nocturnal BG, timing and duration of nocturnal hypoglycemia, fasting BG, lipid profile, psychosocial factors, total insulin dose, insulin sensitivity and body composition (weight, BMI, % fat, waist circumference).
Measured: end of 3 months for each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startAug 2000
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Investigators
- Jean_Francois Yale, MD, Principal investigator, McGill Nutrition and Food Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475345
- Sponsor's protocol ID
- A05-M27-00
- Status last verified
- May 2007
- First submitted
- 16 May 2007
- Last updated
- 21 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia in Adults With Type 1 Diabetes Undergoing Intensive Management
- ClinicalTrials.gov ID
- NCT00475345
- Acronym / sponsor ID
- A05-M27-00
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Nocturnal hypoglycemia, Bedtime snacks, Continuous glucose monitoring, Continuous subcutaneous insulin infusion, CSII, Intensive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Aug 2000
- Study completion
- Sep 2001 (actual)
- First posted
- 21 May 2007 (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 determine whether or not bedtime snacks are necessary to prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1 diabetes who are using intensive insulin therapies, either multiple injections of insulin or insulin pump.
We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well adjusted and delivered, especially by use of insulin pump which is considered the "gold standard" for overnight blood glucose control.
Detailed description
Nocturnal hypoglycemia is a significant side effect of insulin replacement therapy and can lead to many problems including coma and death in the most extreme cases and deterioration of glycemic control. Strategies to prevent nocturnal hypoglycemia include development of newer insulins and delivery systems and the use of specific bedtime snack compositions. Detection of nocturnal hypoglycemia, as it occurs in everyday life, has been a problem since most episodes go unnoticed and therefore untreated leading to a very dangerous situation. With the recent availability of technology which allows for continuous glucose monitoring , it has been made possible to detect nocturnal hypoglycemia as it occurs in daily life. As well, this technology allows for the possibility of better titration of therapy.
Therefore, the goal of our study was to use continuous glucose monitoring technology as a tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia as it occurs in daily life. Specifically, we sought to compare the use of insulin pump therapy with no bedtime snacks and using a new type of insulin called an analogue(lispro) versus multiple daily injections of insulin, using the same type of insulin analogue, and with and without bedtime snacks. Therefore, we compared 3 groups: 1) insulin pump with no bedtime snacks; 2) multiple injections with bedtime snacks and 3) multiple injections with no bedtime snacks. The groups were primarily compared for the occurrence and frequency of nocturnal hypoglycemia. Other comparisons included: long term glycemic control (A1c), weight and body composition and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with type 1 diabetes for more than 3 years duration and on intensive insulin therapy using multiple daily injections of insulin (MDI) for at least 1 year prior to study.
Key exclusion criteria (4 listed)
- Pregnant women or intending to become pregnant in next year,
- Significant hepatic or renal disease,
- Active cancer,
- Abuse of alcohol or drugs.
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 |
|---|---|---|
| Bedtime snacks | Behavioural | – |
Primary outcome
Incidence of nocturnal hypoglycemia (< 4mmol/L) occurring between 11pm and 7am, as determined with the Continuous Glucose Monitoring System (CGMS) and hemoglobin A1c
Time frame: end of 3 months for each group
1 secondary outcome
Nadir nocturnal BG, timing and duration of nocturnal hypoglycemia, fasting BG, lipid profile, psychosocial factors, total insulin dose, insulin sensitivity and body composition (weight, BMI, % fat, waist circumference).
Time frame: end of 3 months for each group
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 21 May 2007.
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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.
Jean_Francois Yale, MD principal investigator
McGill Nutrition and Food Science Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime snacks in people with Type 1 Diabetes Mellitus, run by McGill University at 1 site in Canada.
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 1 inclusion and 4 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 21 May 2007. 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 Canada. 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?
Incidence of nocturnal hypoglycemia (< 4mmol/L) occurring between 11pm and 7am, as determined with the Continuous Glucose Monitoring System (CGMS) and hemoglobin A1c (time frame: end of 3 months for each group). 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 21 May 2007.