Diabetes Mellitus, Type 2NCT02294370
Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring
An observational study of Diabetes Mellitus, Type 2, run by Folkhälsan Researech Center at 1 site in Finland.
Trial summary
This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- Type of treatment
- Pill or oral medicine
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2013to Jun 2015
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP-Botnia Study in Finland. The Botnia Study and the PPP-Botnia Study are population based studies investigating type 2 diabetes in western Finland.
Who may be able to join
- Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP (Prevalence, Prediction, Prevention)-Botnia Study in Finland.
- Age 40-75 years
Who cannot join
- Medication with: insulin, glucagon-like peptide-1 (GLP-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (LHRH) analogues
- Pregnancy
- Known changes in retinal fundus photographs
- Known, microalbuminuria
- HbA1c >8%
- Fasting plasma glucose >10 mmol/l
- Medication with metformin, glitazones, gliptins (or acarbose) is allowed but gliptins and acarbose need to be stopped 2 days before testing and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study
This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.
Read the detailed description
Type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling conditions. The onset of type 2 diabetes is a gradual shift from normal to abnormal, giving rarely noticeable symptoms at its early stages or even in later stages when damage has already been caused. Due to the gradual onset, the diagnosis is often delayed, and as much as half of the asymptomatic patients remain undetected. The diagnostic criteria for diabetes are based on artificial boundaries reflecting the risk of complications related to diabetes. The golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is both time consuming and costly. This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects at the early stages of diabetes | Subjects at the early stages of diabetes, individuals with impaired glucose tolerance (IGT, 2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l (n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose levels in tissue fluid
continuous glucose monitoring system
Measured: continuous monitoring for 1 week
Secondary outcomes (1)
capillary glucose
for the calibration of the continuous glucose monitoring system
Measured: 4 times a day for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
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 2Studies 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
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folkhälsan Researech Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, University of Padova, Universidad Politecnica de Madrid, University of Pavia, Fondazione Salvatore Maugeri, Asociación Española Para el Desarrollo de la Epidemiologia Clínica, Lund University, Soluciones Tecnologias para la Salud y el Bienestar SA, National Technical University of Athens
- Responsible party
- Sponsor
- Investigators
- Tiinamaija Tuomi, MD,lecturer, Principal investigator, Folkhalsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294370
- Sponsor's protocol ID
- Botnia012014
- Status last verified
- Mar 2016
- First submitted
- 17 Nov 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Soliman A, DeSanctis V, Yassin M, Elalaily R, Eldarsy NE. Continuous glucose monitoring system and new era of early diagnosis of diabetes in high risk groups. Indian J Endocrinol Metab. 2014 May;18(3):274-82. doi: 10.4103/2230-8210.131130.
PubMed 24944918Wang C, Lv L, Yang Y, Chen D, Liu G, Chen L, Song Y, He L, Li X, Tian H, Jia W, Ran X. Glucose fluctuations in subjects with normal glucose tolerance, impaired glucose regulation and newly diagnosed type 2 diabetes mellitus. Clin Endocrinol (Oxf). 2012 Jun;76(6):810-5. doi: 10.1111/j.1365-2265.2011.04205.x.
PubMed 21854404
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study
- ClinicalTrials.gov ID
- NCT02294370
- Acronym / sponsor ID
- Botnia012014
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Folkhälsan Researech CenterUniversity, hospital or other
- Collaborators
- Medtronic, University of Padova, Universidad Politecnica de Madrid, University of Pavia, Fondazione Salvatore Maugeri, Asociación Española Para el Desarrollo de la Epidemiologia Clínica, Lund University, Soluciones Tecnologias para la Salud y el Bienestar SA, National Technical University of Athens
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Nov 2014 (estimated)
- 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.
This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.
Detailed description
Type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling conditions. The onset of type 2 diabetes is a gradual shift from normal to abnormal, giving rarely noticeable symptoms at its early stages or even in later stages when damage has already been caused. Due to the gradual onset, the diagnosis is often delayed, and as much as half of the asymptomatic patients remain undetected. The diagnostic criteria for diabetes are based on artificial boundaries reflecting the risk of complications related to diabetes. The golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is both time consuming and costly. This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects at the early stages of diabetes | – | –Subjects at the early stages of diabetes, individuals with impaired glucose tolerance (IGT, 2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l (n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP-Botnia Study in Finland. The Botnia Study and the PPP-Botnia Study are population based studies investigating type 2 diabetes in western Finland.
Key inclusion criteria (2 listed)
- Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP (Prevalence, Prediction, Prevention)-Botnia Study in Finland.
- Age 40-75 years
Key exclusion criteria (7 listed)
- Medication with: insulin, glucagon-like peptide-1 (GLP-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (LHRH) analogues
- Pregnancy
- Known changes in retinal fundus photographs
- Known, microalbuminuria
- HbA1c >8%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
glucose levels in tissue fluid
Time frame: continuous monitoring for 1 week
continuous glucose monitoring system
1 secondary outcome
capillary glucose
Time frame: 4 times a day for 1 week
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 14 Mar 2016.
- Background: PubMed 24944918Soliman A, DeSanctis V, Yassin M, Elalaily R, Eldarsy NE. Continuous glucose monitoring system and new era of early diagnosis of diabetes in high risk groups. Indian J Endocrinol Metab. 2014 May;18(3):274-82. doi: 10.4103/2230-8210.131130.
- Background: PubMed 21854404Wang C, Lv L, Yang Y, Chen D, Liu G, Chen L, Song Y, He L, Li X, Tian H, Jia W, Ran X. Glucose fluctuations in subjects with normal glucose tolerance, impaired glucose regulation and newly diagnosed type 2 diabetes mellitus. Clin Endocrinol (Oxf). 2012 Jun;76(6):810-5. doi: 10.1111/j.1365-2265.2011.04205.x.
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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.
Tiinamaija Tuomi, MD,lecturer principal investigator
Folkhalsan
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 2, run by Folkhälsan Researech Center at 1 site in Finland.
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 2 inclusion and 7 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 14 Mar 2016. 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 Finland. 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 levels in tissue fluid (time frame: continuous monitoring for 1 week). 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 NCT02294370, 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 14 Mar 2016.