DiabetesDIALOGNCT01628341
French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in France.
Trial summary
This non-interventional study is conducted in Europe. The study is both retrospective and prospective. The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin
- How many people
- 4,424 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Sep 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 3811 patients with Type 1 or Type 2 diabetes are expected to be recruited. Patients will be asked to complete 2 self-assessment questionnaires, one retrospective and one prospective, to characterize severe hypoglycaemias during the last 12 months (retrospective questionnaire) and severe/non-severe hypoglycaemias during the coming month after inclusion (prospective questionnaire).
Who may be able to join
- Patients with Type 1 or Type 2 Diabetes Mellitus
- Patients treated by insulin for at least 12 months
- Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements
- Patients able to complete the questionnaires
- Patients who have accepted to participate to the survey (signature of an information notice)
Who cannot join
- Patients with Type 2 Diabetes Mellitus not treated with insulin
- Females who are currently pregnant or lactating or who were pregnant during the previous year
Trial locations and contacts
1 site in 1 country.
About this study
This non-interventional study is conducted in Europe. The study is both retrospective and prospective.
The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.
- Being tested
- insulin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulinDrug
Patients will be asked to complete 2 self-assessment questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes (type 1 and 2) | Not described Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)
Measured: During the one-month follow-up after inclusion in study
Secondary outcomes (14)
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
Measured: During the last 12 months before inclusion in study
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
Measured: During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia
Measured: During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia
Measured: During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)
Measured: During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
Measured: During the last 12 months before inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
Measured: During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes
Measured: During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes
Measured: During the one-month follow-up after inclusion in study
Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)
Measured: During the one-month follow-up after inclusion in study
Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode)
Measured: During the one-month follow-up after inclusion in study
Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver
Measured: During the one-month follow-up after inclusion in study
Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life
Measured: During the one-month follow-up after inclusion in study
Change in planned daily activities; work: effectiveness, missing hours or days for sick leave
Measured: During the one-month follow-up after inclusion in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 4,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628341
- Sponsor's protocol ID
- INS-3988
- Other IDs
- U1111-1131-8540
- Acronym
- DIALOG
- Status last verified
- Jan 2017
- First submitted
- 22 Jun 2012
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cariou B, Fontaine P, Eschwege E, Lievre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24.
PubMed 25465273
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients
- ClinicalTrials.gov ID
- NCT01628341
- Acronym / sponsor ID
- DIALOG / INS-3988
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,424 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jun 2012 (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 non-interventional study is conducted in Europe. The study is both retrospective and prospective.
The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes (type 1 and 2) | – | Drug: insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 3811 patients with Type 1 or Type 2 diabetes are expected to be recruited. Patients will be asked to complete 2 self-assessment questionnaires, one retrospective and one prospective, to characterize severe hypoglycaemias during the last 12 months (retrospective questionnaire) and severe/non-severe hypoglycaemias during the coming month after inclusion (prospective questionnaire).
Key inclusion criteria (5 listed)
- Patients with Type 1 or Type 2 Diabetes Mellitus
- Patients treated by insulin for at least 12 months
- Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements
- Patients able to complete the questionnaires
- Patients who have accepted to participate to the survey (signature of an information notice)
Key exclusion criteria (2 listed)
- Patients with Type 2 Diabetes Mellitus not treated with insulin
- Females who are currently pregnant or lactating or who were pregnant during the previous year
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 |
|---|---|---|
| insulinPatients will be asked to complete 2 self-assessment questionnaires | Drug | Patients with diabetes (type 1 and 2) |
Primary outcome
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)
Time frame: During the one-month follow-up after inclusion in study
14 secondary outcomes
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
Time frame: During the last 12 months before inclusion in study
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
Time frame: During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia
Time frame: During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia
Time frame: During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)
Time frame: During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
Time frame: During the last 12 months before inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
Time frame: During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes
Time frame: During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes
Time frame: During the one-month follow-up after inclusion in study
Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)
Time frame: During the one-month follow-up after inclusion in study
Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode)
Time frame: During the one-month follow-up after inclusion in study
Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver
Time frame: During the one-month follow-up after inclusion in study
Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life
Time frame: During the one-month follow-up after inclusion in study
Change in planned daily activities; work: effectiveness, missing hours or days for sick leave
Time frame: During the one-month follow-up after inclusion in study
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 19 Jan 2017.
- Results publication: PubMed 25465273Cariou B, Fontaine P, Eschwege E, Lievre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in France.
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 5 inclusion and 2 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 19 Jan 2017. 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 France. 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?
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe) (time frame: During the one-month follow-up after inclusion in study). 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 NCT01628341, which also lists 1 linked publication.
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 19 Jan 2017.