The Adjustment of Doses in Diabetes Mellitus Type I

September 20, 2023 updated by: Hisham Ibrahim, Liwa College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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 at dinner.

Description

Inclusion Criteria:

  • Diabetic patient

Exclusion Criteria:

  • Normal patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose level
Time Frame: 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.
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liwa College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Actual)

November 6, 2022

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4a-V8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results

IPD Sharing Time Frame

Open

IPD Sharing Access Criteria

any one

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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