Exercise in Type One Diabetes Study (ExTOD)

In order to establish a network of clinical research studies, the study coordinator of a recently set up lifestyle intervention study was approached. The 'Exercise in Type One Diabetes (ExTOD)' study was recruiting individuals with new onset type 1 diabetes at the University of Birmingham. The chief investigator and study coordinator of this study kindly agreed to adapt the study's protocol in order to allow access to samples

from participants undergoing meal stimulated tests. This provided a means to facilitate the collection of samples for future measurement of gut hormone levels in individuals with new onset type 1 diabetes. As part of the collaboration I agreed to facilitate the set up of a second wave of study sites wishing to recruit to the ExTOD study. The study had initially begun recruiting in November 2011 with 5 centres: United Bristol Healthcare NHS Trust, Taunton and Somerset NHS Trust, North Bristol NHS Trust, Gloucestershire Hospitals NHS Trust and University Hospitals Birmingham Foundation NHS Trust. The study sites involved in the second wave that I was involved in setting up commenced recruiting between October 2012 – February 2013 and included: East & North Herts NHS Trust, Oxford University Hospitals NHS Trust, Mid Yorkshire Hospitals NHS Trust, Royal United Hospital Bath NHS Trust and Yeovil District Hospital NHS Foundation Trust. The process that I undertook involved: 1) screening the site, 2) setting up the site and 3) initiating the site.

1. The screening process started with the identification of a site and a principal investigator. The site was then screened to ensure the appropriate staff and equipment were in place to run the study.

2. Setting up the site involved gaining study site approval from local research and development departments and coordinating the signing of contracts by the Study Sponsor and the representatives of the study site.

3. Initiation of the site then followed after approval by both the sponsor and local Research and Development department. This was the final practical process required before the site could commence the study. For the ExTOD study this involved identifying a provider to educate the local research staff on motivational interviewing, show them how to use the activity monitors, and

finally talk through the study visits.

2.2.1 Protocol outline for the 'Exercise in Type One Diabetes study (ExTOD)'

The Exercise in Type One Diabetes (ExTOD) Study (www.birmingham.ac.uk/extod) has three main aims:

1. To determine whether motivation interviewing can increase the amount of exercise taken by an individual with newly diagnosed type 1 diabetes.

2. To act as a pilot study to determine whether an increase in the quantity of exercise an individual with newly diagnosed type 1 diabetes undertakes can reduce the rate of decline in c-peptide.

3. To provide feasibility data for an extended study by measuring: the enrolment period, site count, patient recruitment rate, screen failures, drop out rates and completion rates.

The “Exercise in Type One Diabetes study (ExTOD)” was funded by a “Research for Patient Benefit” grant from the National Institute of Health Research and supported through the Birmingham & Black Country Comprehensive Local Research Network (UKCRN ID: 12984). The chief investigator was Dr Parth Narendran and the University of Birmingham acted as the sponsor (ref: RG_09-123). Ethics approval was granted by the Birmingham, East, North & Solihull research ethics committee in February 2010 (ref: 10/H1206/4). University Hospitals Birmingham Foundation NHS Trust - Research and Development department approved the study in March 2010 (ref: RRK3950). The ethics committee submissions, NHS R&D submissions, study protocol, standard operating protocols and all documentation associated with the study was authored by Dr

Parth Narendran and Dr Amy Kennedy.

Screening for the study commenced in early November 2011 with the first participant recruited to the study in mid November 2011.

Study inclusion criteria:

1. Individuals between 16-60 years old and within twelve weeks of a clinical diagnosis of type 1 diabetes.

2. Individuals able and willing to self-monitor blood glucose and record their results.

3. Individuals who are considered safe to exercise.

4. Individuals willing and able to take multiple dose injection insulin. 5. Individuals able to increase their current exercise levels.

Study exclusion criteria:

1. Individuals who are pregnant or planning a pregnancy within the time frame of the study.

2. Individuals with a blood pressure greater than 180/100 mm Hg.

3. Individuals taking medication that affects heart rate (e.g. beta blocker, calcium channel antagonist, etc.)

4. Individuals with either ischaemic heart disease or psychiatric or physical disease that would prevent exercise.

5. Individuals who are due to undergo major surgery which would prevent exercise for more than 6 weeks within the time frame of the study.

Following recruitment (Visit 1) into the study, participants were questioned about their medical history, underwent anthropometric measurements, and asked to wear an activity monitor. The study involved a total of 12 study visits in the control group and 17 in the intervention (motivational interviewing) group:

• 1 enrolment visit

• 1 visit (baseline) review by a dietician.

• 3 visits (baseline, 6 months & 12 month) involved meal stimulated test. • 3 visits (baseline, 6 months & 12 month) involved exercise fitness test.

• 4 visits (3 between baseline-6 months, 1 between 6-12months) involved clinical assessment by diabetes specialist nurse

• Intervention group - 5 extra visits (3 between baseline-6 months, 2 between 6- 12months) involved motivational interviewing by a trained specialist nurse.

All participants recruited in Birmingham underwent the meal stimulated test and exercise fitness test at the Wellcome Trust Clinical Research Facility at the Queen Elizabeth Hospital Birmingham.