Making Ramadhan Fasting a Safer Experience With Technology Study

NCT02189135 | Completed Phase 4

• 1 other identifier: MRFAST
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia with an increasing prevalence. Despite the best effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2 diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will generally consume large quantities of fried and sugary foods when they break their fast or during the night. Given the importance and public health significance of poor diabetes management and its associated risk especially during Ramadan, the investigators aim to test the intervention of using remote monitoring within community provider practice for patients with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer which can directly feedback the patients glycaemic levels to the physicians will reduce and even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain euglycaemic throughout the whole Ramadan month.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan

  Week 4

Secondary Outcomes (4)

• Mean change in fructosamine from start of Ramadan (day -1) to end of Ramadan (day 29) in usual care versus telemedicine

  Week 4

• Total number of hypoglycaemic rates in usual care versus telemedicine during Ramadan

  Week 4

• Total number of hypoglycaemic rates in usual care versus telemedicine from baseline to end of treatment

  Week 12

• Glycaemic control of patients measured with HbA1c in patients under usual care versus telemedicine from baseline to end of treatment

  Week 12

Study Arms (2)

Usual care

NO INTERVENTION

Usual care from physician/ doctor

Telemedicine

EXPERIMENTAL

Mobile wireless glucometer with feedback from physicians

Device: Telemedicine

Interventions

Telemedicine DEVICE

The glucometer acts by automatically uploading any glucose readings to an online portal. A summary of the patient's glycaemic and metabolic control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available. All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient

Also known as: Myglucohealth wireless bluetooth glucometer

Telemedicine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment. This will be determined via self-report with verification (medical records, current treatment, or test results meeting the 2009 Malaysian Clinical Practice Guideline for Management of Type 2 Diabetes Mellitus (4th edition) criteria of fasting blood glucose \> 7.0 mmol/L , symptoms of hyperglycaemia with casual plasma glucose \>11.1mmol/L or two-hour plasma glucose \>11.1mmol/L after a 75gram oral glucose load)
• HbA1c of \> 7.5% but less than 11.0% within the most recent 3 months. Individuals with HbA1c exceeding this level may require more urgent care and as such will be asked to seek treatment
• Aged 18 - 75 years are eligible. Participants older than 75 years of age are excluded due to the increased risk of competing mortality and potential safety concerns related to hypoglycaemia
• Willing or has an intention to fast for at least 15 days during Ramadan
• Access to internet and an e-mail address , or access to a smartphone with 3G services in the intervention group
• Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation

You may not qualify if:

• Unable or unwilling to give informed consent or communicate with local study staff
• Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
• Hospitalization for depression in past six months
• Plans to relocate to an area or travel plans that do not permit full participation in the study
• Lack of support from primary health care provider or family members
• History of bariatric surgery, small bowel resection, or extensive bowel resection
• Currently pregnant or nursing
• Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
• Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Sponsors & Collaborators

• Monash University: lead
• Segi University: collaborator

Study Sites (1)

Klinik Kesihatan Pandamaran

Klang, Selangor, 42000, Malaysia

Location

Related Publications (3)

• Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

  PMID: 37435938 DERIVED

• Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Type 2 diabetes patient's perspective on Ramadan fasting: a qualitative study. BMJ Open Diabetes Res Care. 2017 May 8;5(1):e000365. doi: 10.1136/bmjdrc-2016-000365. eCollection 2017.

  PMID: 28761651 DERIVED

• Lee JY, Lee SW, Nasir NH, How S, Tan CS, Wong CP. Diabetes telemonitoring reduces the risk of hypoglycaemia during Ramadan: a pilot randomized controlled study. Diabet Med. 2015 Dec;32(12):1658-61. doi: 10.1111/dme.12836. Epub 2015 Jul 15.

  PMID: 26103794 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shaun Lee, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shaun Lee

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

MY (1)