The Adjustment of Doses in Diabetes Mellitus Type I

Sponsor

Liwa College (Other)

Overall Status

Completed

CT.gov ID

NCT06055829

Collaborator

(none)

Enrollment

Location

2.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: Insulin injection and blood glucose

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 24, 2022

Actual Primary Completion Date :

Nov 6, 2022

Actual Study Completion Date :

Jan 20, 2023

Outcome Measures

Primary Outcome Measures

Glucose level [Two weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

41 Years to 41 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Diabetic patient

Exclusion Criteria:

Normal patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hisham Ibrahim	Abu Dhabi		United Arab Emirates

Sponsors and Collaborators

Liwa College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Hisham Ibrahim, Dr., Liwa College

ClinicalTrials.gov Identifier:

NCT06055829

Other Study ID Numbers:

4a-V8

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Hisham Ibrahim, Dr., Liwa College

Diabetes mellitus, Insulin injection, Patients training

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Insulin

Study Results

No Results Posted as of Sep 28, 2023