Topics

A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?

2019-10-28 13:57:18 | BioPortfolio

Summary

Fasting Ramadan is one of the five pillars of Islam and requested only from healthy adults to abstain from eating and drinking from sunrise to sunset. People with type 1 diabetes mellitus (TIDM) are exempted from fasting, as their chronic condition could be adversely affected by fasting. Nevertheless, many insist on fasting and it has been experienced and advocated that with proper education and follow-up with health care providers, people with uncomplicated T1DM could safely fast Ramadan.

Adopted IDF-DAR guidelines for people with diabetes planning to fast Ramadan are available but are based on opinions and largely untested. These current guidelines recommend a significant reduction in insulin doses and a change of the timing of basal insulin and highlight the increased risk of hypoglycemia. Our local DAFNE patient's experience with fasting during the past years points towards no significant changes in insulin timing with minor reductions of insulin without a significant increase in the risk of hypoglycemia. There is no randomized control trial to test the efficacy of the IDF-DAR guidelines specifically looking at changing basal insulin timing This study aims to assess whether insulin doses require reduction and change of timing during Ramadan. We aim to compare the effectiveness and safety of two management strategies. This will help to provide robust guidelines to help both health care professionals and people with type 1 diabetes

Description

INTRODUCTION/BACKGROUND

Diabetes and Ramadan (DAR) and IDF international collaboration created the IDF-DAR guidelines which include the practical recommendations for HCP to better manage people with diabetes who plan to fast Ramadan. The National Institute for Health and Clinical Excellence has recommended implementation of structured education programs to help individuals enhance their knowledge about diabetes and improve their management techniques. The educational program needs to ensure that patients can cope with specific situations such as exercise, illness which should extend to religious fasting.

We have developed and adopted a 5-day educational program widely used in the UK for delivery in Kuwait. The course trains adults with Type 1 Diabetes in the UK to manage their condition more effectively using multiple injections. As part of our course, DAFNE graduates receive yearly Ramadan diabetes educational specific session (separate from the main 5-day course) and all DAFNE graduates are invited. During the 6 hours session, we seek patients' views, willingness to fast and introduced to the specific food that commonly consumed during Ramadan. Previous personal experiences of fasting and problems encountered are collected. Patients who are intending to fast and whom we deem safe to undertake this, receive clear and practical guidance on safe fasting during Ramadan.

Current Gaps in the Literature

Most intervention studies up to date have been performed in controlled conditions, using a small number of participants and with a short duration of intervention, ie not closely related to real-life. The variability of insulin regimens, dietary patterns and physical activity levels and the complexity of ways in which they are tested make it difficult to identify the individual effects of each component on diabetes outcomes. As a result, further research is needed to help expand the currently available knowledge regarding the management of diabetes and its associated complications when fasting during Ramadan. We believe that large, randomized, controlled intervention trials are necessary to broaden our understanding of the implications of fasting and evaluate guidance without bias. Further research into the effect of fasting during Ramadan on both high (measured by SMBG and HbA1C) and low glucose (measured by the incidence of hypoglycemia) is required. Robust evaluation of evidence-based guidelines will lead to useful practical assistance for patients who can fulfill religious obligations despite the additional burden of insulin-treated diabetes. This pilot study builds on an educational program, DAFNE which includes many of the elements of flexible eating and insulin dose adjustment which should permit patients to fast safely.

Study Rationale

Adopted IDF-DAR guidelines are available but recommend a significant reduction in insulin doses and change to the timing of basal insulin for MDI users. There is no evidence that fasting increases the risk of hypoglycemia, and glucose tends to be higher during Ramadan, as a result of a reduction in insulin doses.

Local DAFNE patient's experience with fasting during the past years points towards no significant changes in insulin doses (minor reductions were needed in basal or bolus insulin doses) without the need of the change of basal insulin timing, however we are not aware without running a randomized control trial (RCT) to test DAFNE guidelines versus DAR-IDF guidelines.

OBJECTIVES / HYPOTHESIS

The primary objectives of this study are to assess whether insulin doses require reduction during Ramadan and change of timing and whether fasting increases the risk of hypoglycemia for people with T1DM who fast Ramadan.

Hypothesis:

This study hypothesized no changes in insulin dose timing and fasting does not increase the risk of hypoglycemia.

METHODOLOGY

Potential patients will be identified via DAFNE database at DDI. Candidate subjects who are current users of (FSL) and administer insulin via (MDI) will be contacted by phone and will be offered conditional participation in the study. Those agreeable will be given the consent form with the preferred language (Arabic or English) and will be scheduled a study visit. The same will be done for insulin pump users.

Study design

Open-label randomized controlled trial in people with uncomplicated T1DM fasting during Ramadan (1 month) comparing insulin management according to IDF-DAR guidelines (IDF-DAR arm) and local experience (DAFNE arm), on time spent in range (TIR) of 4-10 mmol/L, and hypoglycaemic self-reported episodes.

Primary outcome:

1. Percentage TIR 4-10mmol/L

2. Rate of self-reported hypoglycemia by participants

Secondary outcomes:

1. Percentage time <4mmol/L

2. Percentage time >10mmol/L

3. Number of sensors detected hypoglycaemic events

4. Number of days needed to break the fast

Inclusion/exclusion criteria:

Mentioned in separate section

Intervention:

The intervention in this study is insulin dosing and timing during Ramadan, and it will be assessed by creating two groups of participants that are similar to one another in all respects, except to the intervention to be assessed. Participants will be DAFNE graduates who were trained properly on carbohydrate counting and adjusting insulin doses according to the carbs consumed. The whole cohort will be using the same insulin regimen; multiple daily injections (MDI) and monitoring glucose using the same monitoring systems; flash glucose monitoring (FGM) system: FreeStlye Libre (FSL) Reader and sensors, and self-monitoring of blood glucose (SMBG) using the FreeStyle optimum test strips, or insulin pump.

The null hypothesis is that there is no difference in the rates of hypoglycemia between basal insulin taken at iftar time versus bedtime in people with T1DM during fasting Ramadan.

Ramadan Workshop

DAFNE structured education program was conducted to all subjects in a stage their life with T1DM. Consequently, subjects are familiar with carbohydrate counting and aware of dose adjustments needed to cover their meals. Nevertheless, this workshop will include food tables with real food models of traditional Ramadan plates. The workshop includes advices on healthy eating habits during Ramadan. General instructions will be provided to all participants which are part of DAFNE Ramadan protocol.

Ramadan Visits, Daily messages, and Calls

Visits: Weekly or whenever required, to upload FSL reader and adjust doses without crossing the arm recommendations for adjustments. This can be done in person or via the cloud Daily Messages: Did you fast full day? If no, was it due to hypoglycemia, and did you check BG to confirm hypoglycemia? Daily count of hypoglycemic episodes? Was all confirmed with SMBG? Are you wearing a glucose sensor, and scanning readings at least once every 8 hours? Calls: If participant was not answering messages, calls will be initiated. A message or call should be performed in the last day of Ramadan to instruct participants about the insulin dosing and timing post-Ramadan

Post-Ramadan Visit:

1. Upload FSL reader

2. Physical examination will be repeated, including weight and routine blood will be collected again including HbA1C, FBC, U&Es with eGFR, full chemistry, urine ACR within three months

3. This will conclude the study visits for the subject

DATA ANALYSIS

For statistical analysis, this can be done using two-tailed unpaired t-test as we are comparing results of different subjects who are in different conditions and the change can be rise or fall in time in range.

Telemonitoring data including daily questionnaires, WhatsApp messages, food logs, and meal pictures will be collected and added to an excel sheet for analysis.

FreeStlye libre software will be used to extract reports and data export readings of FSL readers. The following analysis will be carried out for both arms and for all fasted days:

1. Total average of 24 hours of glucose

2. Estimated A1c

3. Percentage time in range 4.0-10mmol/L

4. Percentage time spent <4.0mmol/L

5. Percentage of time spent >10mmol/L

6. Low glucose events

7. Low glucose duration

8. Total patient-reported hypoglycemia events (from telemonitoring data mentioned above) One-way ANOVA to compare means of percentage time in all above glucose ranges with an alpha <0.05

IMPORTANCE OF THE RESEARCH OUTCOMES

IDF-DAR guidelines recommend reducing insulin doses in people with T1DM or insulin-dependent T2DM to prevent hypoglycemia especially in the 3 to 4 hours before iftar, in addition to changing the basal insulin timing. DAFNE earlier work at DDI demonstrated that fasting Ramadan did not require a significant reduction of background basal insulin (most 5-10% if needed) without reduction of meal bolus insulin. It also advocates that there is no increased risk of hypoglycemia in Ramadan if done with the support of diabetes with prior education and close glucose monitoring. However, there is significant evidence that glucose tends to be higher during Ramadan especially post-iftar, as a result of eating feasting behavior and most probably a reduction in insulin doses as per guidelines. There is no consensus between guidelines and local experience and no evidence about the cut-off reduction in insulin doses which requires running this randomized control trial which hypothesized that the change in eating behavior in Ramadan does not change insulin requirement and carb counting will provide safe insulin dosing during Ramadan similar to that outside Ramadan

ETHICAL CONSIDERATIONS Informed Consent Forms

We will give a patient information sheet for the participant to keep and ask for written informed consent. We will document that 3 copies have been distributed: one to the participant, another to his/her doctor and one for the study team

CONFIDENTIALITY

All hard copies of any study material will be kept in locked cabinets on the premises of DDI. Subject identifiable information will be only available to study team and ethics committee for inspection in case this becomes required.

Study Design

Conditions

Type 1 Diabetes Mellitus

Location

Dasman Diabetes Institute
Kuwait
Dasman
Kuwait
15462

Status

Enrolling by invitation

Source

Dasman Diabetes Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-28T13:57:18-0400

Clinical Trials [5829 Associated Clinical Trials listed on BioPortfolio]

ECG Changes Including QT Dispersion and Corrected QT Prolongation in Children and Adolescents With Type 1 Diabetes

Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes...

A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199)

The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabet...

Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Safety and Tolerability Study of Oral LGD-6972 for Type 2 Diabetes Mellitus

Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ...

MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

PubMed Articles [9374 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of Cinnamon in Type 2 Diabetes Mellitus and Pre-diabetes patients: A Meta-analysis and Meta-regression.

Cinnamon has been used as a dietary component and in the management of diabetes mellitus. This study systematically reviewed and synthesized evidence on the efficacy of cinnamon for the treatment of t...

Risk of Mortality and Hospitalization After Post-Pancreatitis Diabetes Mellitus vs Type 2 Diabetes Mellitus: A Population-Based Matched Cohort Study.

To investigate the risk of mortality and hospitalization in individuals with post-pancreatitis diabetes mellitus (PPDM) compared with those with type 2 diabetes mellitus (T2DM).

Markers for undiagnosed type 2 diabetes mellitus during pregnancy - population-based retrospective cohort study.

To examine possible markers for undiagnosed type 2 diabetes in early-onset gestational diabetes mellitus (GDM).

Clinical Impact of the TCF7L2 Gene rs7903146 Type 2 Diabetes Mellitus Risk Polymorphism in Women with Gestational Diabetes Mellitus: Impaired Glycemic Control and Increased Need of Insulin Therapy.

The single nucleotide polymorphism in TCF7L2 rs7903146 is associated with an increased risk of type 2 diabetes mellitus and gestational diabetes mellitus. Mechanisms by which this mutation acts, and i...

Development and multi-cohort validation of a clinical score for predicting type 2 diabetes mellitus.

Many countries lack resources to identify patients at risk of developing Type 2 diabetes mellitus (diabetes). We aimed to develop and validate a diabetes risk score based on easily accessible clinical...

Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

More From BioPortfolio on "A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?"

Quick Search

Relevant Topics

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...


Searches Linking to this Trial