Treatment intensification in type 2 diabetes mellitus and obesity

Zawiejska, Agnieszka; McAleese, Jane; Yemparala, Prasad; Taheri, Shahrad

doi:10.3399/bjgp13x665152

Cited by 7 publications

(8 citation statements)

References 2 publications

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“…1 More than half the deaths were in those under 60 years of age. 1 The prevailing approach to diabetes management has been to focus on glycaemic, lipid and blood pressure control through medication introduction and escalation, 2 based on the assumption that T2DM is a life-long disease with progressive decline in beta cell function and greater atherosclerosis. Increasingly, this view has been questioned through observations from bariatric surgery 3 4 as well as recent dietary intervention trials, [5][6][7] where diabetes remission was observed to accompany significant weight loss.…”

Section: Introductionmentioning

confidence: 99%

Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

Zaghloul

Chagoury²,

Elhadad

et al. 2020

BMJ Open

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ObjectivesDiabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive lifestyle intervention (ILI) for weight loss and diabetes remission. We report on the recruitment process and baseline characteristics of the DIADEM-I cohort based on origin (Middle East vs North Africa), and waist circumference.DesignDIADEM-I is an open-label randomised, controlled, parallel group RCT recruiting young individuals (18–50 years) with early type 2 diabetes (≤3 years since diagnosis) originating from MENA. Individuals from primary care were randomised to usual medical care or ILI (total dietary replacement phase using meal replacement products, followed by staged food reintroduction and physical activity support). The primary outcome is weight loss at 12 months. Other outcomes are glycaemic control and diabetes remission.SettingPrimary care, Qatar.Participants147 (73% men) randomised within DIADEM-I who were included in the final trial data analysis.Outcome measuresRecruitment metrics, and baseline clinical and metabolic characteristics.ResultsOf 1498 people prescreened, 267 (18%) were invited for screening and 209 (78%) consented. 173 (83%) were eligible. 15 (7%) withdrew before randomisation and the remaining 158 were randomised. Mean age was 42.1 (SD 5.6) years and mean body mass index was: 36.3 (5.5) kg/m2 (women) and 34.4 (5.4) kg/m2 (men). Mean diabetes duration was 1.8 (1.0) years and mean glycosylated haemoglobin (HbA1c) was 7.0% (1.30) (52.5 mmol/mol (SD 14.3)). Participants originated from 13 countries. Those from North Africa reported greater physical activity and had lower family history of diabetes. 90% of subjects were taking diabetes medications and 31% antihypertensives. Those with greater waist circumference had significantly higher insulin resistance and lower quality of life.ConclusionRecruitment of participants originating from the MENA region into the RCT was successful, and study participation was readily accepted. While DIADEM-I participants originated from 13 countries, there were few baseline differences amongst participants from Middle East versus North Africa, supporting generalisability of RCT results.Trial registration numberISRCTN20754766; NCT03225339

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Section: Introductionmentioning

confidence: 99%

Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

Zaghloul

Chagoury²,

Elhadad

et al. 2020

BMJ Open

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“…T2DM prevalence is increasing globally but at a more rapid pace in the Middle East and North Africa (MENA) region, and particularly in Arab countries in the Gulf Cooperation Council [2,3]. T2DM management is focused around glycaemic, blood pressure and lipid control [4]. However, even with well-established and enhanced clinical services, achieving appropriate clinical and biochemical targets to prevent, diminish and reverse diabetes complications, is challenging [5].…”

Section: Background and Rationale {6a}mentioning

confidence: 99%

Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus—a study protocol

Suleiman

Alkasem

Amer

et al. 2022

Trials

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Background Mobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile application was specifically built for people with T2DM with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile app. Methods The planned study is an ongoing open-label randomised controlled trial in which adults living with T2DM treated with insulin will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline to 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects for assessment of the primary outcome. Discussion We hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If the Qatar Diabetes Mobile Application Trial (QDMAT) demonstrates this, it will inform clinical services for the future self-management of T2DM. Trial registration ClinicalTrials.gov Identifier: NCT03998267. Registered on 26 June 2019

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“…Self-monitoring generally includes blood glucose measurements for insulin-treated DM, but may also include blood pressure, body weight, physical activity and dietary intake measures. As T2DM progresses, there is a need for treatment intensi cation and the introduction of insulin, which is associated with hypoglycaemia and undesirable weight gain (5,6).…”

Section: Background and Rationale {6a}mentioning

confidence: 99%

Qatar Diabetes Mobile Application Trial (QDMAT): An Open-Label Randomised Controlled Trial To Examine The Impact of Using A Mobile Application To Improve Diabetes Care In Type 2 Diabetes Mellitus – A Study Protocol

Suleiman

Alkasem

Amer

et al. 2021

Preprint

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BackgroundMobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with diabetes. A new mobile application was specifically built for people with diabetes with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile App.MethodsThe planned study is an ongoing open-label randomised controlled trial in which insulin-treated adults with type 2 diabetes mellitus (T2DM) will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline at 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments, and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects ( for assessment of the primary outcome. DiscussionWe hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If QDMAT demonstrates this, it will inform clinical services for the future self-management of T2DM.Trial Registration,ClinicalTrials.gov Identifier: NCT03998267) Registered on 26 June 2019

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Treatment intensification in type 2 diabetes mellitus and obesity

Cited by 7 publications

References 2 publications

Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus—a study protocol

Qatar Diabetes Mobile Application Trial (QDMAT): An Open-Label Randomised Controlled Trial To Examine The Impact of Using A Mobile Application To Improve Diabetes Care In Type 2 Diabetes Mellitus – A Study Protocol

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