Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

NCT01941238 | Completed

• 1 other identifier: RE12-002
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoglycemia

  Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users \[Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)\]

  5 weeks

Secondary Outcomes (4)

• Number of fasting days lost

  5 weeks

• Glycemic control

  Two (2) months

• overnight hypoglycemia

  5 weeks

• Rate of acute complications

  5 weeks

Study Arms (2)

Insulin pump

MDI

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patient with renal or hepatic impairment
• Patient with diagnosed adrenal insufficiency
• Pregnancy
• Alcoholism
• Any diagnosed psychiatric disease
• Can not do SMBG

Sponsors & Collaborators

• Reem Mohammad Alamoudi: lead

Study Sites (1)

National Guards Hospital

Dammam, 31412, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 30294552 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Fasting; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Feeding Behavior; Behavior; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Endocrinology

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 13, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

SA (1)