Using fixed meal boluses for children with Type 1 diabetes on Medtronic Minimed 780G pumps
Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps
This study is testing if using the same meal insulin dose for kids with Type 1 diabetes on Medtronic Minimed 780G pumps works as well as giving them personalized doses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 7 Years to 19 Years |
| Sex | All |
| Sponsor | Tartu University Hospital Academic / other |
| Locations | 1 site (Tartu, Tartumaa) |
| Trial ID | NCT06372392 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of universal fixed meal bolus coefficients compared to individualized coefficients in pediatric patients with Type 1 diabetes using Medtronic Minimed 780G insulin pumps. A total of 20 participants aged 7 to 19 will be randomized into two groups: one receiving fixed meal boluses and the other receiving personalized dosing for a period of 14 days. The outcomes will be analyzed using data from Carelink reports to assess blood glucose control and insulin management.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 7-19 with a diagnosis of Type 1 diabetes for at least one year who are using a Medtronic Minimed 780G pump.
Not a fit: Patients with active coeliac disease or other chronic diseases that could affect diabetes management may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify meal bolus calculations for children with Type 1 diabetes, potentially improving their glycemic control.
How similar studies have performed: While this specific approach is novel, similar studies exploring fixed meal bolus strategies have shown promising results in improving diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 7-19 * type 1 diabetes diagnosed at least 1 year ago * insulin in the dose 0,5-1,0 units/day/kg * MiniMed 780G pump usage at least 1 month. Exclusion Criteria: * Active coeliac disease * Chronic disease possible to influence diabetes treatment * Acute disease at the moment of recruitment
Where this trial is running
Tartu, Tartumaa
- TartuUH — Tartu, Tartumaa, Estonia (Recruiting)
Study contacts
- Principal investigator: Aleksandr Peet — Tartu University Hospital
- Study coordinator: Aleksandr Peet, MD, PhD
- Email: aleksandr.peet@kliinikum.ee
- Phone: 5532256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.