Type 1 Diabetes (T1D)OBT StudiesNCT07021690
The Steno Opti-Bolus-Timing Studies
A study testing High glyceamic index meal and Low glyceamic index meal in people with Type 1 Diabetes (T1D), run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- High glyceamic index meal and Low glyceamic index meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR > 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol/L
Who cannot join
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.
- Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology
Herlev, DK-2730
About this study
Official title: Timing Insulin for Meals Using AID Systems
The project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates.
We hypothesise that a bolus given 15 minutes before the meal will result in the best blood glucose levels after the meal, regardless of the type of carbohydrates.
Participants will attend 6 experimental days over a maximum of 3 months, where they will be served either breakfast or lunch at the research site, depending on sub-study (breakfast or Lunch sub-study). Three different bolus timings will be tested, with either rapidly absorbed carbohydrates or slowly absorbed carbohydrates, in a randomized order for each participant. Participants will take insulin for the meal using the bolus calculator in the pump, either 15 minutes before, at the start of the meal, or 30 minutes after the meal. The development in sensor glucose will then be monitored for up to 4 hours after the meal.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- High glyceamic index meal, Low glyceamic index meal
- Keywords
- AID system, bolus timing, Glycemic index
- 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.
High glyceamic index mealOther
Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with high glycemic index.
Low glyceamic index mealOther
Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with low glycemic index.
| Study group | Role | What they receive |
|---|---|---|
| Start high-GI | Active comparator | T=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for high GI meal, meal starts T=30: meal ends Receives: Other: High glyceamic index meal |
| Pre high-GI | Experimental | T=0: meal bolus for high GI meal T=15: meal starts T=30: meal ends Receives: Other: High glyceamic index meal |
| Post high-GI | Experimental | T=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for high GI meal Receives: Other: High glyceamic index meal |
| Pre low-GI | Experimental | T=0: meal bolus for low GI meal T=15: meal starts T=30: meal ends Receives: Other: Low glyceamic index meal |
| Start low-GI | Experimental | T=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for low GI meal, meal starts T=30: meal ends Receives: Other: Low glyceamic index meal |
| Post low-GI | Experimental | T=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for low GI meal Receives: Other: Low glyceamic index meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SG between three meal bolus delivery times for meals with two levels of glycemic index
The primary objective is to compare the change in SG (from -15 min before the meal to the highest SG level measured during 0-270 min after start of meal intake) between three meal bolus delivery times for meals with two levels of glycemic index (GI) (high-GI and low-GI meals, respectively).
Measured: From -15 min before the meal to 270 min after meal intake
Secondary outcomes (8)
Area under the post-meal CGM-curve
Measured: From -15 min before the meal to 270 min after meal intake
Difference in amount of insulin given for autocorrections during the post-meal period between the three bolus methods for each type of meal.
Measured: From -15 min before the meal to 270 min after meal intake
Distribution of Time Below Range (TBR)
Distribution of TBR in the observation period of 4 hours and 45 minutes around the meal between the three bolus methods for each GI meal.
Measured: From -15 min before the meal to 270 min after meal intake
Difference in the number of Time Below Range events (with SG< 3.9 mmol/l)
Difference in the number of Time Below Range (TBR) events (with SG< 3.9 mmol/l) in the observation period of 4 hours and 45 minutes around the meal between the three bolus methods for each GI meal.
Measured: From -15 min before the meal to 270 min after meal intake
Distribution of Time In target Range (TIR)
Distribution of Time In target Range (TIR) in the 4 hours and 45 minutes observation period around the meal between the three bolus methods for each GI meal.
Measured: From -15 min before the meal to 270 min after meal intake
Distribution of Time In Tight target Range (TITR)
Distribution of Time In Tight target Range (TITR), in the 4 hours and 45 minutes observation period around the meal between the three bolus methods for each GI meal.
Measured: From -15 min before the meal to 270 min after meal intake
Distribution of Time Above Range (TAR)
Distribution of Time Above Range (TAR), in the 4 hours and 45 minutes observation period around the meal between the three bolus methods for each GI meal.
Measured: From -15 min before the meal to 270 min after meal intake
Number of hypoglycemia events (PG< 3.9 mmol/L )
Measured: From -15 min before the meal to 270 min after meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- Randomised
- Intervention model
- Crossover
- Model description
- the study contains two sub-studies: breakfast and lunch
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Nørgaard, Steno Diabetes Center Copenhagen
- Investigators
- Kirsten Nørgaard, Professor, Principal investigator, Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021690
- Sponsor's protocol ID
- Copenhagen University Hospital
- Acronym
- OBT Studies
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing Insulin for Meals Using AID Systems
- ClinicalTrials.gov ID
- NCT07021690
- Acronym / sponsor ID
- OBT Studies / Copenhagen University Hospital
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- AID system, bolus timing, Glycemic index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- 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 project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates.
We hypothesise that a bolus given 15 minutes before the meal will result in the best blood glucose levels after the meal, regardless of the type of carbohydrates.
Participants will attend 6 experimental days over a maximum of 3 months, where they will be served either breakfast or lunch at the research site, depending on sub-study (breakfast or Lunch sub-study). Three different bolus timings will be tested, with either rapidly absorbed carbohydrates or slowly absorbed carbohydrates, in a randomized order for each participant. Participants will take insulin for the meal using the bolus calculator in the pump, either 15 minutes before, at the start of the meal, or 30 minutes after the meal. The development in sensor glucose will then be monitored for up to 4 hours after the meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- the study contains two sub-studies: breakfast and lunch
| Arm | Type | Receives |
|---|---|---|
| Start high-GI | Active comparator | Other: High glyceamic index mealT=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for high GI meal, meal starts T=30: meal ends |
| Pre high-GI | Experimental | Other: High glyceamic index mealT=0: meal bolus for high GI meal T=15: meal starts T=30: meal ends |
| Post high-GI | Experimental | Other: High glyceamic index mealT=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for high GI meal |
| Pre low-GI | Experimental | Other: Low glyceamic index mealT=0: meal bolus for low GI meal T=15: meal starts T=30: meal ends |
| Start low-GI | Experimental | Other: Low glyceamic index mealT=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for low GI meal, meal starts T=30: meal ends |
| Post low-GI | Experimental | Other: Low glyceamic index mealT=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for low GI meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR > 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol/L
Key exclusion criteria (2 listed)
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.
- Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results
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 |
|---|---|---|
| High glyceamic index mealMeal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with high glycemic index. | Other | Post high-GI, Pre high-GI, Start high-GI |
| Low glyceamic index mealMeal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with low glycemic index. | Other | Post low-GI, Pre low-GI, Start low-GI |
Primary outcome
Change in SG between three meal bolus delivery times for meals with two levels of glycemic index
Time frame: From -15 min before the meal to 270 min after meal intake
The primary objective is to compare the change in SG (from -15 min before the meal to the highest SG level measured during 0-270 min after start of meal intake) between three meal bolus delivery times for meals with two levels of glycemic index (GI) (high-GI and low-GI meals, respectively).
8 secondary outcomes
Area under the post-meal CGM-curve
Time frame: From -15 min before the meal to 270 min after meal intake
Difference in amount of insulin given for autocorrections during the post-meal period between the three bolus methods for each type of meal.
Time frame: From -15 min before the meal to 270 min after meal intake
Distribution of Time Below Range (TBR)
Time frame: From -15 min before the meal to 270 min after meal intake
Difference in the number of Time Below Range events (with SG< 3.9 mmol/l)
Time frame: From -15 min before the meal to 270 min after meal intake
Distribution of Time In target Range (TIR)
Time frame: From -15 min before the meal to 270 min after meal intake
Distribution of Time In Tight target Range (TITR)
Time frame: From -15 min before the meal to 270 min after meal intake
Distribution of Time Above Range (TAR)
Time frame: From -15 min before the meal to 270 min after meal intake
Number of hypoglycemia events (PG< 3.9 mmol/L )
Time frame: From -15 min before the meal to 270 min after meal intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- 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.
Kirsten Nørgaard, Professor principal investigator
Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High glyceamic index meal and Low glyceamic index meal in people with Type 1 Diabetes (T1D), run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 2 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: opening soon, as of the sponsor's last update on 15 Jun 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Rytter, RN, PhD (+45 39680800, karen.rytter@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SG between three meal bolus delivery times for meals with two levels of glycemic index (time frame: From -15 min before the meal to 270 min after meal intake). 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 15 Jun 2025.