Type 1 DiabetesNCT02248454
Insulin Bolus Required for High Fat Foods in Type 1 Diabetes
A study testing Lispro in people with Type 1 Diabetes, run by Joslin Diabetes Center.
Trial summary
The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals. Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Lispro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Apr 2015
- 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
- Adult patients (aged 18-75 years) with type 1 diabetes > 3 years, on insulin pump therapy.
Who cannot join
- History or symptoms suggestive of gastroparesis or gastric dysmotility; History of celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion; Eating disorder; Diet allergies; Special diet restrictions, such as vegan; Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan); High-titre insulin autoantibodies with delayed insulin kinetics; Women who are breast feeding, pregnant, or wanting to become pregnant.
About this study
Official title: Evaluation of Insulin Bolus for High Fat Meals
The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.
Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (U/kg).
Read the detailed description
Subjects for this study will be adults with type 1 diabetes who use an insulin pump for diabetes self-management.
Subjects will be admitted to the clinical research center in the morning in the fasting state. Subjects will have several admissions. During the initial two admissions, subjects will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5 admissions during which they will receive the pizza-high fat meal with progressively increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target range 80-180 mg/dL.
- Conditions
- Type 1 Diabetes
- Being tested
- Lispro
- 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.
LisproDrug
Also called Humalog
Increasing insulin doses
| Study group | Role | What they receive |
|---|---|---|
| Insulin bolus dose/type | Experimental | Lispro insulin, dose calculated by modeling analysis Receives: Drug: Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of fat "sensitivity"
To test the hypothesis that incremental dose increase required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (TDD; U/kg) we will perform regression analysis with TDD as independent variable and the increase in insulin requirements (calculated as percent change for high fat vs low fat meal) as the dependent variable.
Measured: 0-360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Howard Wolpert, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248454
- Sponsor's protocol ID
- High fat bolus
- Status last verified
- Apr 2017
- First submitted
- 22 Sep 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.
PubMed 27388474
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Insulin Bolus for High Fat Meals
- ClinicalTrials.gov ID
- NCT02248454
- Acronym / sponsor ID
- High fat bolus
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Sep 2014 (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 evaluate an insulin bolus for use to cover higher fat meals.
Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (U/kg).
Detailed description
Subjects for this study will be adults with type 1 diabetes who use an insulin pump for diabetes self-management.
Subjects will be admitted to the clinical research center in the morning in the fasting state. Subjects will have several admissions. During the initial two admissions, subjects will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5 admissions during which they will receive the pizza-high fat meal with progressively increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target range 80-180 mg/dL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin bolus dose/type | Experimental | Drug: LisproLispro insulin, dose calculated by modeling analysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (aged 18-75 years) with type 1 diabetes > 3 years, on insulin pump therapy.
Key exclusion criteria (1 listed)
- History or symptoms suggestive of gastroparesis or gastric dysmotility; History of celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion; Eating disorder; Diet allergies; Special diet restrictions, such as vegan; Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan); High-titre insulin autoantibodies with delayed insulin kinetics; Women who are breast feeding, pregnant, or wanting to become pregnant.
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 |
|---|---|---|
| LisproAlso: HumalogIncreasing insulin doses | Drug | Insulin bolus dose/type |
Primary outcome
Predictors of fat "sensitivity"
Time frame: 0-360 minutes
To test the hypothesis that incremental dose increase required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (TDD; U/kg) we will perform regression analysis with TDD as independent variable and the increase in insulin requirements (calculated as percent change for high fat vs low fat meal) as the dependent variable.
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 Apr 2017.
- Derived from this study: PubMed 27388474Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.
- 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.
Howard Wolpert, MD principal investigator
Joslin Diabetes Center
Questions about this trial
What is this clinical trial studying?
A study testing Lispro in people with Type 1 Diabetes, run by Joslin Diabetes Center.
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 1 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Predictors of fat "sensitivity" (time frame: 0-360 minutes). 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 NCT02248454, which also lists 1 linked publication.
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 Apr 2017.