DiabetesNCT02306681
A Survey on Low Blod Sugar Among Insulin-treated Patients With Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 8 sites in 8 countries.
Trial summary
This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 7,315 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 30 Oct 2014to 14 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months who are 18 years or older, ambulatory, literate, and have signed the Informed Consent form may participate in the study.
Who may be able to join
- Informed consent obtained before any trial-related activities
- Patient with T1DM or T2DM treated with insulin for more than 12 months
- Male or female patient at least 18 years of age at the time of inclusion in the study
Who cannot join
- Previous participation in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey
- Non-ambulatory patients
- Simultaneous participation in any other clinical study with an investigational product
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Turkey (Türkiye)1 site
Novo Nordisk Investigational Site
Ankara, 06100
United Arab Emirates1 site
Novo Nordisk Investigational Site
Ajman, 21499
About this study
Official title: An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.
- Being tested
- No treatment given
- 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.
No treatment givenOther
This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.
| Study group | Role | What they receive |
|---|---|---|
| SAQ-Self-Assessment Questionnaire | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who experience at least 1 hypoglycaemic episode
Measured: During the 4-week prospective observational period
Secondary outcomes (18)
Incidence of any hypoglycaemic episodes
Measured: In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of hypoglycaemic episodes requiring hospital admission
Measured: In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of severe hypoglycaemic episodes
Measured: In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of non-severe hypoglycaemic episodes
Measured: In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of documented symptomatic hypoglycaemic episodes
Measured: In the 4 weeks after the baseline visit (day 1)
Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms
Measured: In the 4 weeks following the baseline visit (day 1)
Incidence of hypoglycaemic episodes
Measured: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)
Incidence of probable symptomatic hypoglycaemia
Measured: In the 4 weeks following the baseline visit (day 1)
Frequency of blood glucose monitoring
Measured: Over 1 day
Patient reported fear of hypoglycaemia
Measured: Over one day
Patient reported recovery times
Measured: One day
Proportion of patients consulting a doctor
Measured: Over one day
Proportion of patients increasing calorie intake
Measured: Over one day
Proportion of patients avoiding physical exercise
Measured: Over one day
Proportion of patients reducing or skipping insulin dose
Measured: Over one day
Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes
Measured: Over one day
Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes
Measured: Over one day
DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores
Measured: Over last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start30 Oct 2014
- Primary completion14 May 2015
- Study completion14 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,315 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
- NCT02306681
- Sponsor's protocol ID
- INS-4177
- Other IDs
- U1111-1161-9157
- Status last verified
- Mar 2019
- First submitted
- 12 Nov 2014
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pathan F, Goh SY, Rudijanto A, Gadekar A, Jain A, Nicodemus N Jr. Hypoglycaemia among Insulin-Treated Patients with Diabetes: Southeast Asia Cohort of IO HAT Study. J ASEAN Fed Endocr Soc. 2018;33(1):28-36. doi: 10.15605/jafes.033.01.05. Epub 2018 Apr 4.
PubMed 33442108Emral R, Pathan F, Cortes CAY, El-Hefnawy MH, Goh SY, Gomez AM, Murphy A, Abusnana S, Rudijanto A, Jain A, Ma Z, Mirasol R; IO HAT Investigator Group. Self-reported hypoglycemia in insulin-treated patients with diabetes: Results from an international survey on 7289 patients from nine countries. Diabetes Res Clin Pract. 2017 Dec;134:17-28. doi: 10.1016/j.diabres.2017.07.031. Epub 2017 Aug 9.
PubMed 28951336Emral R, Tetiker T, Sahin I, Sari R, Kaya A, Yetkin I, Cil SU, Tutuncu NB; IO HAT investigator group. An international survey on hypoglycemia among insulin-treated type I and type II diabetes patients: Turkey cohort of the non-interventional IO HAT study. BMC Endocr Disord. 2018 Feb 13;18(1):9. doi: 10.1186/s12902-018-0238-2.
PubMed 29433560Pathan MF, Fariduddin M, Nazimuddin K, Mollah AS, Islam Siddiqui MN, Hassan KA, Ferdous HS, Rahman MH, Ashrafuzzaman SM, Sobhan MJ, E-Tanvir Haider MR, Amin MF. The Incidence of Hypoglycemia among Insulin-Treated Patients with Type 1 or Type 2 Diabetes: Bangladeshi Cohort of International Operations-Hypoglycemia Assessment Tool Study. Indian J Endocrinol Metab. 2018 May-Jun;22(3):379-386. doi: 10.4103/ijem.IJEM_545_17.
PubMed 30090731Mirasol R, Nicodemus N Jr, Jain A, Gadekar AV, Yu-Gan S. Self-Reported Hypoglycemia in Insulin-Treated Patients with Diabetes: Results from the Philippine Cohort of the International Operations Hypoglycemia Assessment Tool (IO HAT) Study. J ASEAN Fed Endocr Soc. 2018;33(1):12-21. doi: 10.15605/jafes.033.01.03. Epub 2018 Apr 3.
PubMed 33442106Gomez AM, Chica LG, Burbano AF, Vasquez EM, Escobar JA, Arias PM, Molina DI. Survey on hypoglycemia among insulin-treated patients with diabetes: The Colombian International Operations Hypoglycemia Assessment Tool population. Biomedica. 2019 Sep 1;39(3):576-586. doi: 10.7705/biomedica.4365.
PubMed 31584770Rudijanto A, Saraswati MR, Yunir E, Kumala P, Puteri HH, Mandang VV. Indonesia Cohort of IO HAT Study to Evaluate Diabetes Management, Control, and Complications in Retrospective and Prospective Periods Among Insulin-Treated Patients with Type 1 and Type 2 Diabetes. Acta Med Indones. 2018 Jan;50(1):26-37.
PubMed 29686173
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02306681
- Acronym / sponsor ID
- INS-4177
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,315 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 14 May 2015 (actual)
- First posted
- 3 Dec 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 is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAQ-Self-Assessment Questionnaire | – | Other: No treatment given |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months who are 18 years or older, ambulatory, literate, and have signed the Informed Consent form may participate in the study.
Key inclusion criteria (3 listed)
- Informed consent obtained before any trial-related activities
- Patient with T1DM or T2DM treated with insulin for more than 12 months
- Male or female patient at least 18 years of age at the time of inclusion in the study
Key exclusion criteria (5 listed)
- Previous participation in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey
- Non-ambulatory patients
- Simultaneous participation in any other clinical study with an investigational product
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 |
|---|---|---|
| No treatment givenThis study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods. | Other | SAQ-Self-Assessment Questionnaire |
Primary outcome
The percentage of patients who experience at least 1 hypoglycaemic episode
Time frame: During the 4-week prospective observational period
18 secondary outcomes
Incidence of any hypoglycaemic episodes
Time frame: In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of hypoglycaemic episodes requiring hospital admission
Time frame: In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of severe hypoglycaemic episodes
Time frame: In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of non-severe hypoglycaemic episodes
Time frame: In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of documented symptomatic hypoglycaemic episodes
Time frame: In the 4 weeks after the baseline visit (day 1)
Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms
Time frame: In the 4 weeks following the baseline visit (day 1)
Incidence of hypoglycaemic episodes
Time frame: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)
Incidence of probable symptomatic hypoglycaemia
Time frame: In the 4 weeks following the baseline visit (day 1)
Frequency of blood glucose monitoring
Time frame: Over 1 day
Patient reported fear of hypoglycaemia
Time frame: Over one day
Patient reported recovery times
Time frame: One day
Proportion of patients consulting a doctor
Time frame: Over one day
Proportion of patients increasing calorie intake
Time frame: Over one day
Proportion of patients avoiding physical exercise
Time frame: Over one day
Proportion of patients reducing or skipping insulin dose
Time frame: Over one day
Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes
Time frame: Over one day
Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes
Time frame: Over one day
DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores
Time frame: Over last 4 weeks
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 8 Mar 2019.
- Background: PubMed 33442108Pathan F, Goh SY, Rudijanto A, Gadekar A, Jain A, Nicodemus N Jr. Hypoglycaemia among Insulin-Treated Patients with Diabetes: Southeast Asia Cohort of IO HAT Study. J ASEAN Fed Endocr Soc. 2018;33(1):28-36. doi: 10.15605/jafes.033.01.05. Epub 2018 Apr 4.
- Results publication: PubMed 28951336Emral R, Pathan F, Cortes CAY, El-Hefnawy MH, Goh SY, Gomez AM, Murphy A, Abusnana S, Rudijanto A, Jain A, Ma Z, Mirasol R; IO HAT Investigator Group. Self-reported hypoglycemia in insulin-treated patients with diabetes: Results from an international survey on 7289 patients from nine countries. Diabetes Res Clin Pract. 2017 Dec;134:17-28. doi: 10.1016/j.diabres.2017.07.031. Epub 2017 Aug 9.
- Results publication: PubMed 29433560Emral R, Tetiker T, Sahin I, Sari R, Kaya A, Yetkin I, Cil SU, Tutuncu NB; IO HAT investigator group. An international survey on hypoglycemia among insulin-treated type I and type II diabetes patients: Turkey cohort of the non-interventional IO HAT study. BMC Endocr Disord. 2018 Feb 13;18(1):9. doi: 10.1186/s12902-018-0238-2.
- Results publication: PubMed 30090731Pathan MF, Fariduddin M, Nazimuddin K, Mollah AS, Islam Siddiqui MN, Hassan KA, Ferdous HS, Rahman MH, Ashrafuzzaman SM, Sobhan MJ, E-Tanvir Haider MR, Amin MF. The Incidence of Hypoglycemia among Insulin-Treated Patients with Type 1 or Type 2 Diabetes: Bangladeshi Cohort of International Operations-Hypoglycemia Assessment Tool Study. Indian J Endocrinol Metab. 2018 May-Jun;22(3):379-386. doi: 10.4103/ijem.IJEM_545_17.
- Derived from this study: PubMed 33442106Mirasol R, Nicodemus N Jr, Jain A, Gadekar AV, Yu-Gan S. Self-Reported Hypoglycemia in Insulin-Treated Patients with Diabetes: Results from the Philippine Cohort of the International Operations Hypoglycemia Assessment Tool (IO HAT) Study. J ASEAN Fed Endocr Soc. 2018;33(1):12-21. doi: 10.15605/jafes.033.01.03. Epub 2018 Apr 3.
- Derived from this study: PubMed 31584770Gomez AM, Chica LG, Burbano AF, Vasquez EM, Escobar JA, Arias PM, Molina DI. Survey on hypoglycemia among insulin-treated patients with diabetes: The Colombian International Operations Hypoglycemia Assessment Tool population. Biomedica. 2019 Sep 1;39(3):576-586. doi: 10.7705/biomedica.4365.
- Derived from this study: PubMed 29686173Rudijanto A, Saraswati MR, Yunir E, Kumala P, Puteri HH, Mandang VV. Indonesia Cohort of IO HAT Study to Evaluate Diabetes Management, Control, and Complications in Retrospective and Prospective Periods Among Insulin-Treated Patients with Type 1 and Type 2 Diabetes. Acta Med Indones. 2018 Jan;50(1):26-37.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
8 sites in 8 countries: 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 8 sites in 8 countries.
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 3 inclusion and 5 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bangladesh, Colombia, Egypt, Philippines, Singapore and 3 more countries. 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?
The percentage of patients who experience at least 1 hypoglycaemic episode (time frame: During the 4-week prospective observational period). 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 NCT02306681, which also lists 7 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 8 Mar 2019.