[Summary text]
BMI < 1 år - kritisk
HbA1c >= 1 år - kritisk
Følgende outcomes er vurderet vigtige:
Vægt =< 1 år
HbA1c< 1 år
LDL =< 1 år
Kostvaner - længste follow-up
QoL – længste follow-up
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Control (BC group)
Intervention (BGC group)
Included criteria: Newly diagnosed persons with Non insulin dependent diabetes melitus (NIDDM), free of diabetes complications, recent heart attacks or other serious acute illness (cancer or surgery) in the previous 4 weks; or an illness requiring corticosteroid therapy
Excluded criteria: Diabetes complications (gastroparesis, renal disease), recent heart attacks or stroke, other serious, acute illnesses (cancer, or surgery within the previous four weeks), or an illness requiring corticosteroid therapy.
Intervention Characteristics
Control (BC group)
Intervention (BGC group)
Continuous:
Sponsorship source: This research was funded by The American Dietetic Association
Country: US
Setting: Outpatient diabetes centers in three states (Minnesota, Florida and Colorado)
Comments:
Authors name: Marion J Franz
Institution: International Diabetes Center
Email: not stated
Address: Park Nicollet Medical Foundation, 3800 Park Nicollet Bvld, Minneapolis, MN 55416
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Henning Keinke Andersen Outcome measures were performed after 6 weeks and 6 months. The outcome table (<12 months) represents values for 6 months
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Routine care control group
Intervention Group (On-site diabetic self-management education)
Included criteria: Patients with newly diagnosed Type 2 Diabetes (by a physician and based upon ADA criteria.
Excluded criteria: Pregnancy, undergoing dialysis, received an amputation, comorbid blindness, systemic illness such as cancer or cadiovascular disease (MRI or stroke)
Intervention Characteristics
Routine care control group
Intervention Group (On-site diabetic self-management education)
Continuous:
Sponsorship source: This project was supported by grants funded by the NationalHealth Research Institute (96A1-HDPP08-017) of Taiwan)
Country: Taiwan
Setting: Diabetes patients from Public Health bureau of Kaohsiung, a city in southern Taiwan
Comments: Corresponding author: Shyi-Jang Shin
Authors name: Meng-Chuan Huang
Institution: Division of Endocrinology and Metabolism, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Email: sjshin@kmu.edu.tw
Address: Department of Public Health, Faculty of Medicine, Kaohsiung Medical University, Kaohsiung,Taiwan
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Henning Keinke Andersen LDL cholesterol measured as mg/dl, coverted to mmol/l by dividing the figures by 38.78 - change values after 12 months for control group was 0.0026 +/- 0.94, and for the intervention group -0.15 +/- 0.93
Dichotomous outcomes:
Henning Keinke Andersen Dropouts reported pre-intervention: 21 from the control group and 18 from the intervention group. However, the baseline characteristics did not include these, so the reported figures represent the actual numbers finalising the 12 months (as an ITT analysis)
Adverse outcomes:
Wrong intervention
Wrong study design
in spanish
QoL results from primary study from 2012, included in PICO 4
Wrong intervention
in spanish
Wrong intervention
unbalanced study
waiting list control
Wrong outcomes
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Randomisation was done according to computergenerated
allocation
Insufficient information to make a judgement
Computer generated
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Allocations remained concealed by the trial coordinator until patients
attended visit 4, when they saw a dietitian who telephoned
to get the next code.
Insufficient information to make a judgement
Not sufficient information to permit judgement
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Dietitians, nurses, and patients were
aware of allocation, but doctors were not. All assessments
were done by nurses.
Neither patient nor personnel were blinded, but unclear whether this will have an impact on the objective reported outcomes.
Neither patient nor personnel were blinded, but unclear whether this will have an impact on the objective reported outcomes.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Insufficient information to make a judgement
Not sufficient information to permit judgement
Attrition bias due to amount, nature or handling of incomplete outcome data
Drop out rate 18%, but thoroughly expl. Attention to the number of participants monitored for LDL outcome, both at baseline and after 6 mths! However this outcome is not critical.
drop outs reported pre-treatment. All data from participants at baseline also reported after 12 months
Reporting bias due to selective outcome reporting
all outcome reported, but for unknown reasons two of the key outcomes (BMI and Weight) at different times??
All outcomes reported
Bias due to problems not covered elsewhere in the table
Insufficient information to make a judgement
None known