Automated insulin delivery for meal management in Type 1 Diabetes
Evaluation on Glycemic Control Using Two Different Meal Announcement Plans in Adolescents With Type 1 Diabetes on Minimed 780G Hybrid Closed Loop System
This study is testing if a simpler way of managing meals helps teenagers with Type 1 Diabetes using an insulin pump keep their blood sugar levels better controlled compared to regular meal counting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Sidra Medicine Academic / other |
| Locations | 1 site (Doha, Qa) |
| Trial ID | NCT06130215 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to compare glucose control in adolescents aged 12-17 with Type 1 Diabetes using two different meal management approaches while on the MiniMed 780G insulin pump. Participants will be divided into two groups based on their carbohydrate counting skills: one group will use a simplified meal announcement protocol, while the other will follow a regular carbohydrate counting protocol. The study will last for three months, with an additional nine-month extension, and will assess the impact of these approaches on glycemic control and diabetes-related distress. Participants will undergo baseline and follow-up HbA1c assessments to evaluate the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 12-17 with a clinical diagnosis of Type 1 Diabetes for over a year and using more than 8.0 units of insulin daily.
Not a fit: Patients who are pregnant or have untreated diabetes retinopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the burden of carbohydrate counting for adolescents with Type 1 Diabetes, leading to improved glycemic control and enhanced quality of life.
How similar studies have performed: While similar approaches have been explored, this specific method of simplified meal management using automated insulin delivery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. Age 12 and above at the initiation of the system 3. Total daily insulin use of great than 8.0 units per day over a 1-week period 4. Willing and able (access to internet from home) to download information into the Medtronic CareLink software 5. Clinically able to start the AHCL system Exclusion Criteria: 1. Pregnancy 2. Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.
Where this trial is running
Doha, Qa
- Sidra Medicine — Doha, Qa, Qatar (Recruiting)
Study contacts
- Principal investigator: Goran Petrovski, PhD — Sidra Medicine
- Study coordinator: Goran Petrovski, PhD
- Email: goran.endo@gmail.com
- Phone: 0097440035588
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.