Clinical trial NCT01354925: Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan
Official title: Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Type 2
Treatment During Ramadan
Keywords: Diabetes type 2
Fasting
Ramadan
Insulin analogues
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Several studies have demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during fasting. When treating diabetic patients with a treatment guideline the rate of these complications can be reduced. Little data is available on patients with type 2 diabetes treated with insulin. The investigators therefore propose to assess the effect of a protocol containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard care patients receive during this period. The investigators assume that patients receiving the intervention will have better glucose control during the Ramadan compared to patients receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes and most of them fast during the Ramadan the results of this intervention may be significant and may improve the care of these patients allowing Muslims to respect their religious obligations without compromising their health.


Eligibility criteria: Inclusion Criteria:

All of these criteria should be present.

1. Patients with a diagnosis of type 2 diabetes treated with insulin (premix preparations or basal and rapid acting insulin) with or without metformin and/or a sulfonylurea drug for at least three months
2. HbA1c in the past three months ≤ 10%
3. Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
4. Age \> 18 years

Exclusion Criteria:

Any of the following:

1. Patients with a diagnosis of type 1 diabetes
2. Hypoglycemia unawareness
3. Hypersensitivity to levemir
4. Hypersensitivity to NovoMix70
5. Creatinine \> 2.5 mg/l
6. AST and or ALT \> 1.5 times the upper limit
7. Pregnancy
8. Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation

Primary outcomes:
measure: Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.
timeFrame: days 23-30 of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit HMO
Study officials:
affiliation: Clalit HMO
name: Naim Shehadeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shehadeh N, Maor Y; Ramadan Study Group. Effect of a new insulin treatment regimen on glycaemic control and quality of life of Muslim patients with type 2 diabetes mellitus during Ramadan fast - an open label, controlled, multicentre, cluster randomised study. Int J Clin Pract. 2015 Nov;69(11):1281-8. doi: 10.1111/ijcp.12695. Epub 2015 Jul 31.