The Adjustment of Doses in Diabetes Mellitus Type I

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

The Adjustment of Doses in Diabetes Mellitus Can Lead to Fluctuation of Glucose Level in Type I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06055829
• Other study ID #: 4a-V8
• Status: Completed
• Start date: October 24, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: September 2023
• Source: Liwa College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study was carried out in a diabetic patient who was starting a new approach for treatment. Previously the patient was treated with Novo-mix insulin injection twice per day, the physician decided to change the treatment strategy to be with three doses of novo-rapid insulin injections per day plus one injection of Lantus SoloStar in dinner. For two weeks we were monitoring the blood glucose level by the FreeStyle Libre sensor. Moreover, the right statistical technique was used for data analysis.

Description:

In this study a diabetic patient is starting a new approach to treatment. Previously, the patient received Novo-Mix insulin injection twice per day (48 Units in breakfast & 28 Units in dinner). Moreover, the physician decided to change the treatment strategy to be with Novo-Rapid insulin injection three times per day (36 Units in breakfast, 36 Units in lunch & 50 Units in dinner) plus one time injection of Lantus SoloStar (50 Units) in dinner. Thus, for monitoring blood glucose level, we are using the FreeStyle Libre-Link. Moreover. Moreover, FreeStyle Libre sensor continuously measures glucose every time when scanned by the mobile and saves the glucose data in the library. Moreover, scanning the FreeStyle Libre sensor with a phone or the reader measures the glucose levels from the interstitial fluid, a thin layer of fluid that surrounds the cells of the tissues in the skin of the patient [4]. The Scan was done every 1-2 hours for a full glycemic profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 20, 2023
• Est. primary completion date: November 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years to 41 Years

Eligibility

Inclusion Criteria:

• Diabetic patient

Exclusion Criteria:

• Normal patient

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin injection and blood glucose
The FreeStyle Libre sensor continuously measures glucose every minute and saves the glucose data. Scan the sensor at least every 8 hours for a full glycemic profile. The below data is displayed after a typical 1-second scan of the FreeStyle LibreLink app or FreeStyle Libre reader via the sensor:

Locations

Country	Name	City	State
United Arab Emirates	Hisham Ibrahim	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Liwa College

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (2)

Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr;46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14. — View Citation

Shi XY, Zhang K, Zhang L. [Type 1 diabetes millitus following short-term recombinant interferon therapy in patient with chronic hepatitis C]. Zhonghua Nei Ke Za Zhi. 2018 Jul 1;57(7):524-525. doi: 10.3760/cma.j.issn.0578-1426.2018.07.012. No abstract available. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose level	the physician decided to change the treatment strategy to be with Novo-Rapid insulin injection three times per day (36 Units in breakfast, 36 Units in lunch & 50 Units in dinner) plus one injection of Lantus SoloStar (50 Units) at dinner.	Two weeks

External Links

•   FreeStyle Libre information
•   Novo-Mix information
•   NovoRapid information