Type 1 Diabetes MellitusNCT01145547
Continuous Glucose Monitoring to Measure Effect of Glycemic Index
A study testing Dexcom Seven® Plus Continuous Glucose Monitoring sensor in people with Type 1 Diabetes Mellitus, run by Legacy Health System at 1 site in United States.
Trial summary
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes. Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Dexcom Seven® Plus Continuous Glucose Monitoring sensor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of type 1 diabetes mellitus
- patients on insulin pump therapy
Who cannot join
- pregnancy
- cardiovascular, cerebrovascular, kidney, or liver disease
- uncontrolled chronic medical conditions
- oral or parenteral corticosteroid use
- immunosuppressant use
- visual or physical impairments that impede the use of a continuous glucose monitoring device
Show all 12Show fewer
- insulin or glucagon allergy
- hypoglycemia unawareness
- requirement of greater than 200 units of insulin per day
- gastroparesis
- any prior gastric surgery
- an allergy to any food items served.
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Health System--Holladay Park Campus
Portland, Oregon, 97232
About this study
Official title: The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.
Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.
Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
Read the detailed description
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Dexcom Seven® Plus Continuous Glucose Monitoring sensor
- Keywords
- glycemic index, Diabetes Mellitus, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Seven® Plus Continuous Glucose Monitoring sensorDevice
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
| Study group | Role | What they receive |
|---|---|---|
| low glycemic index effect on post-prandial peak | Active comparator | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index. Receives: Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor |
| high glycemic index effect on post-prandial peak | Active comparator | Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index. Receives: Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
Measured: Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, W. Kenneth Ward, Legacy Health System
- Investigators
- W K Ward, MD, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145547
- Sponsor's protocol ID
- kw01
- Status last verified
- Oct 2015
- First submitted
- 15 Jun 2010
- Last updated
- 23 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT01145547
- Acronym / sponsor ID
- kw01
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- glycemic index, Diabetes Mellitus, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Posted 5 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.
Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.
Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
Detailed description
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low glycemic index effect on post-prandial peak | Active comparator | Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensorSeven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index. |
| high glycemic index effect on post-prandial peak | Active comparator | Device: Dexcom Seven® Plus Continuous Glucose Monitoring sensorSeven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of type 1 diabetes mellitus
- patients on insulin pump therapy
Key exclusion criteria (12 listed)
- pregnancy
- cardiovascular, cerebrovascular, kidney, or liver disease
- uncontrolled chronic medical conditions
- oral or parenteral corticosteroid use
- immunosuppressant use
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 |
|---|---|---|
| Dexcom Seven® Plus Continuous Glucose Monitoring sensorA Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject. | Device | high glycemic index effect on post-prandial peak, low glycemic index effect on post-prandial peak |
Primary outcome
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
Time frame: Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
W K Ward, MD principal investigator
Legacy Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom Seven® Plus Continuous Glucose Monitoring sensor in people with Type 1 Diabetes Mellitus, run by Legacy Health System 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 2 inclusion and 12 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 23 Oct 2015. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Area Under the Curve for Rise in Breakfast Post-prandial. (time frame: Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast). 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 23 Oct 2015.