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NCT04131049
Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes
NA trial testing High GI calculated by CC (CHGI) in Insulin-Dependent Diabetes Mellitus 1 in 15 participants. Completed in 24 January 2020.
24 November 2019
Quick facts
| Lead sponsor | TC Erciyes University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 15 |
| Start date | 24 June 2019 |
| Primary completion | 24 November 2019 |
| Estimated completion | 24 January 2020 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- High GI calculated by CC (CHGI)
- Low GI calculated by CC (CLGI)
- High GI calculated by FII (FHGI)
- Low GI calculated by FII (FLGI)
Conditions studied
- Insulin-Dependent Diabetes Mellitus 1 — all drugs for Insulin-Dependent Diabetes Mellitus 1 →
Sponsor
TC Erciyes University
Who can join
Adults 14 to 18, any sex, with Insulin-Dependent Diabetes Mellitus 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to compare the impact of carbohydrate counting (CC) method which is standard insulin dose calculation algorithm and food insulin index (FII) method which is a new algorithm on postprandial glucose following a high fat and a high protein meal in adolescent with type 1 diabetes. A randomized, single-blind and crossover trial included 14 adolescents aged 14-18 years with type 1 diabetes. All participants were sent to their homes for 4 consecutive days with a different glycemic index breakfast. The insulin doses of the meals were calculated according to CC and FII methods. Test breakfasts with different GIs and insulin requirements calculated with different algorithms are as follows: High GI calculated by CC (CHGI), low GI calculated by CC (CLGI), high GI calculated by FII (FHGI) and low GI calculated by FII (FLGI).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04131049
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04131049 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TC Erciyes University
- Last refreshed: 9 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04131049.
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