Type 1 DiabetesNCT01693302
Timing of Meal Insulin Boluses for Optimal Postprandial Glycemic Control in Type 1 Diabetes
A study testing Insulin in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food. It is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood… Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2009
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12 to 30 years of age, inclusive
- Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year
- Using carbohydrate counting to dose meal time insulin
- HbA1c value upon enrollment greater than 6.0% and less than 12.0%
- Using CSII therapy for diabetes management for at least three months
- Able and willing to give informed consent/assent to participate
- No expectation that the subject will be moving out of the area of the clinical center during the study
- Willing to consume the same standard frozen meal on all three visits
Who cannot join
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the CGMS sensors or the completion of any aspect of the protocol
- Being unable or unwilling to give informed consent
- Having documented hypoglycemia unawareness
- An episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes
Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food. It is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood glucose peaks compared to administration of insulin immediately before or 20 minutes after starting to eat.
All subjects will eat the same meal on three different occasions. Insulin will be administered at one of the three times at each visit.
Read the detailed description
Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All subjects will be on an insulin pump and use carbohydrate counting as their method for insulin dosing at a meal.
Subjects in this study will complete three study visits lasting from approximately 8:30am until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects will be supplied with the same insulin to maintain consistency between visits and between subjects.
Insulin will be administered at different times, depending upon the randomization group assigned to the participant. The three different times the insulin will be given is either 20 minutes before the meal, immediately before the meal and 20 minutes after the meal. All subjects will complete all three insulin bolus times. Blood glucose will be measured by fingerstick every 30 minutes until the completion of the visit.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin
- Keywords
- Blood Glucose, Meal insulin
- 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.
InsulinOther
Also called Insulin time
The timing of insulin delivery varies with each study visit. The dose is given based on carbohydrate content and blood glucose level. The insulin is given either 20 minutes before the meal, immediately before the meal, or 20 minutes after the meal.
| Study group | Role | What they receive |
|---|---|---|
| -20 minute insulin | Experimental | Insulin for the meal is given 20 minutes prior to starting the meal. Receives: Other: Insulin |
| 0 minute insulin | Experimental | Insulin for the meal is given immediately before starting to eat. Receives: Other: Insulin |
| +20 minute insulin | Experimental | Insulin is given 20 minutes after the start of the meal. Receives: Other: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose area under the curve
Measured: 9:00am until 1:30pm
Secondary outcomes (2)
Glucose values one hour after the meal
Measured: 10:30am
Glucose values two hours after the beginning of the meal
Measured: 11:30am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Peter Chase, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693302
- Sponsor's protocol ID
- 06-0994
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2009
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01693302
- Acronym / sponsor ID
- 06-0994
- Conditions
- Type 1 Diabetes
- Keywords
- Blood Glucose, Meal insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Sep 2012 (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.
Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food. It is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood glucose peaks compared to administration of insulin immediately before or 20 minutes after starting to eat.
All subjects will eat the same meal on three different occasions. Insulin will be administered at one of the three times at each visit.
Detailed description
Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All subjects will be on an insulin pump and use carbohydrate counting as their method for insulin dosing at a meal.
Subjects in this study will complete three study visits lasting from approximately 8:30am until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects will be supplied with the same insulin to maintain consistency between visits and between subjects.
Insulin will be administered at different times, depending upon the randomization group assigned to the participant. The three different times the insulin will be given is either 20 minutes before the meal, immediately before the meal and 20 minutes after the meal. All subjects will complete all three insulin bolus times. Blood glucose will be measured by fingerstick every 30 minutes until the completion of the visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| -20 minute insulin | Experimental | Other: InsulinInsulin for the meal is given 20 minutes prior to starting the meal. |
| 0 minute insulin | Experimental | Other: InsulinInsulin for the meal is given immediately before starting to eat. |
| +20 minute insulin | Experimental | Other: InsulinInsulin is given 20 minutes after the start of the meal. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 12 to 30 years of age, inclusive
- Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year
- Using carbohydrate counting to dose meal time insulin
- HbA1c value upon enrollment greater than 6.0% and less than 12.0%
- Using CSII therapy for diabetes management for at least three months
Key exclusion criteria (4 listed)
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the CGMS sensors or the completion of any aspect of the protocol
- Being unable or unwilling to give informed consent
- Having documented hypoglycemia unawareness
- An episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months
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: Insulin timeThe timing of insulin delivery varies with each study visit. The dose is given based on carbohydrate content and blood glucose level. The insulin is given either 20 minutes before the meal, immediately before the meal, or 20 minutes after the meal. | Other | +20 minute insulin, -20 minute insulin, 0 minute insulin |
Primary outcome
Blood glucose area under the curve
Time frame: 9:00am until 1:30pm
2 secondary outcomes
Glucose values one hour after the meal
Time frame: 10:30am
Glucose values two hours after the beginning of the meal
Time frame: 11:30am
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 26 Sep 2012.
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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.
Peter Chase, MD principal investigator
University of Colorado, Denver
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, run by University of Colorado, Denver at 1 site in United States.
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 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 26 Sep 2012. 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 United States. 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?
Blood glucose area under the curve (time frame: 9:00am until 1:30pm). 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 26 Sep 2012.