Type 1 DiabetesNCT01941238
Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection
An observational study of Type 1 Diabetes, run by Reem Mohammad Alamoudi at 1 site in Saudi Arabia.
Trial summary
Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 142 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2013to Nov 2014
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population of our study is all patients with type1DM treated at three National Guard institutiuons in three different cities of Saudi Arabia (Riyadh, Alahsa, Dammam) with either insulin pump or MDI
Who may be able to join
- DM type 1
- Age ≥14 years
- Patients on insulin pump (more than 3 months)
- Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
- Diagnosis of type 1 DM of more than 6 months.
- Willing to do Self Monitoring Blood Sugar (SMBG)
- Have no other contraindication to fast
Who cannot join
- Patient with renal or hepatic impairment
- Patient with diagnosed adrenal insufficiency
- Pregnancy
- Alcoholism
- Any diagnosed psychiatric disease
- Can not do SMBG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi-dose Insulin Injection
Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan
The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.
- Conditions
- Type 1 Diabetes
- Keywords
- Ramadan, Fasting, Diabetes, Type1, Insulin, Pump
- Medical subject headings
- Diabetes Mellitus, Type 1, Fasting, Diabetes Mellitus, Insulin Resistance
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 |
|---|---|---|
| Insulin pump | Not described | |
| MDI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoglycemia
Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users [Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)]
Measured: 5 weeks
Secondary outcomes (4)
Number of fasting days lost
To estimate the number of days they needed to brake their fast due to acute complications (hypoglycemia, severe hyperglycemia, or DKA).
Measured: 5 weeks
Glycemic control
To assess the glycemic control in the two groups using HbA1c and Fructosamine assays.
Measured: Two (2) months
overnight hypoglycemia
To estimate the rates of overnight hyperglycemia in both groups.
Measured: 5 weeks
Rate of acute complications
To estimate presence of severe hyperglycemia and /or DKA episodes in both groups
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionNov 2014
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 Type 1 DiabetesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reem Mohammad Alamoudi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reem Mohammad Alamoudi, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941238
- Sponsor's protocol ID
- RE12-002
- Status last verified
- Apr 2015
- First submitted
- 4 Sep 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
Publications
Alamoudi R, Alsubaiee M, Alqarni A, Aljaser S, Saleh Y, Salam A, Eledrisi M. Attitudes and habits of patients with type 1 diabetes during fasting Ramadan. J Clin Transl Endocrinol. 2018 Sep 6;14:1-4. doi: 10.1016/j.jcte.2018.09.001. eCollection 2018 Dec.
PubMed 30294552
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi-dose Insulin Injection
- ClinicalTrials.gov ID
- NCT01941238
- Acronym / sponsor ID
- RE12-002
- Conditions
- Type 1 Diabetes
- Keywords
- Ramadan, Fasting, Diabetes, Type1, Insulin, Pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Reem Mohammad AlamoudiUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Sep 2013 (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.
Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan
The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin pump | – | – |
| MDI | – | – |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of our study is all patients with type1DM treated at three National Guard institutiuons in three different cities of Saudi Arabia (Riyadh, Alahsa, Dammam) with either insulin pump or MDI
Key inclusion criteria (7 listed)
- DM type 1
- Age ≥14 years
- Patients on insulin pump (more than 3 months)
- Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
- Diagnosis of type 1 DM of more than 6 months.
Key exclusion criteria (6 listed)
- Patient with renal or hepatic impairment
- Patient with diagnosed adrenal insufficiency
- Pregnancy
- Alcoholism
- Any diagnosed psychiatric disease
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
Incidence of hypoglycemia
Time frame: 5 weeks
Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users [Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)]
4 secondary outcomes
Number of fasting days lost
Time frame: 5 weeks
Glycemic control
Time frame: Two (2) months
overnight hypoglycemia
Time frame: 5 weeks
Rate of acute complications
Time frame: 5 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 7 Apr 2015.
- Derived from this study: PubMed 30294552Alamoudi R, Alsubaiee M, Alqarni A, Aljaser S, Saleh Y, Salam A, Eledrisi M. Attitudes and habits of patients with type 1 diabetes during fasting Ramadan. J Clin Transl Endocrinol. 2018 Sep 6;14:1-4. doi: 10.1016/j.jcte.2018.09.001. eCollection 2018 Dec.
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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 Type 1 Diabetes, run by Reem Mohammad Alamoudi at 1 site in Saudi Arabia.
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 7 inclusion and 6 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 7 Apr 2015. 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 Saudi Arabia. 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?
Incidence of hypoglycemia (time frame: 5 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 NCT01941238, 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 7 Apr 2015.