Diabetes Mellitus, Type 1NCT06055829
The Adjustment of Doses in Diabetes Mellitus Type I
An observational study of Diabetes Mellitus, Type 1, run by Liwa College at 1 site in United Arab Emirates.
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… Read more about this study
- Who is it for?
- Ages 41 to 41 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin injection and blood glucose
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 24 Oct 2022to 20 Jan 2023
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 41 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Diabetic patient
Who cannot join
- Normal patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin injection and blood glucose
- Keywords
- Diabetes mellitus, Insulin injection, Patients training
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin injection and blood glucoseDrug
Also called FreeStyle Libre sensor
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:
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start24 Oct 2022
- Primary completion6 Nov 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Liwa College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Ibrahim, Liwa College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055829
- Sponsor's protocol ID
- 4a-V8
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results
Publications
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.
PubMed 29996274Nauck 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.
PubMed 33068776
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjustment of Doses in Diabetes Mellitus Can Lead to Fluctuation of Glucose Level in Type I
- ClinicalTrials.gov ID
- NCT06055829
- Acronym / sponsor ID
- 4a-V8
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes mellitus, Insulin injection, Patients training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Liwa CollegeUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 41 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Diabetic patient
Key exclusion criteria (1 listed)
- Normal patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin injection and blood glucoseAlso: FreeStyle Libre sensorThe 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: | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 29996274Shi 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.
- Background: PubMed 33068776Nauck 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.
- FreeStyle Libre informationLink provided by the sponsor.
- NovoRapid informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Liwa College at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose level (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.