Trial Outcomes & Findings for Jump Start Shared Medical Appointments for Diabetes With Weight Management (NCT NCT01973972)
NCT ID: NCT01973972
Last Updated: 2023-07-28
Results Overview
measure of glycemic control
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
263 participants
Primary outcome timeframe
48 weeks
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
136
|
|
Overall Study
COMPLETED
|
109
|
117
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Jump Start Shared Medical Appointments for Diabetes With Weight Management
Baseline characteristics by cohort
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 Participants
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 Participants
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
136 participants
n=7 Participants
|
263 participants
n=5 Participants
|
|
Hemoglobin A1c
|
9.0 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3 • n=5 Participants
|
9.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3 • n=7 Participants
|
9.1 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Body mass index
|
35.6 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
35.0 kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
35.3 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksmeasure of glycemic control
Outcome measures
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 Participants
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 Participants
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Hemoglobin A1c
|
8.2 percentage of glycosylated hemoglobin
Standard Deviation 1.6
|
8.3 percentage of glycosylated hemoglobin
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: through 48 weeksAll episodes of hypoglycemia will be recorded by participants on provided standard log forms, noting the date, time, duration, symptoms, treatment received, and concurrent blood glucose. Participants will additionally be asked if they received medical attention for hypoglycemia, and the details if so, since the last assessment. Only one episode will be counted per 24 hours. Serious episodes, defined as \<50 mg/dL or 50-69 mg/dL and requiring assistance, will supersede minor episodes in this case.
Outcome measures
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 Participants
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 Participants
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Hypoglycemic Events
|
3.2 events
Interval 2.1 to 4.4
|
6.6 events
Interval 4.5 to 8.6
|
SECONDARY outcome
Timeframe: 48 weeksAntiglycemic medications, dosages, and schedules will be assessed carefully with the participant and updated at each visit. A Medication Effect Score (MES), based on the potencies and dosages of the medications in a patient's regimen, was devised to reflect the overall intensity of antiglycemic medication. The MES is calculated as the percentage taken of the maximum dose multiplied by the expected hemoglobin A1c lowering effect for each of a participant's medications, which are then summed. Its range is 0 to infinite, with higher scores meaning higher diabetes medication requirement.
Outcome measures
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 Participants
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 Participants
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Medication Effect Score
|
2.2 units on a scale
Standard Deviation 1.5
|
2.7 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 48 weeksweight by electronic scale
Outcome measures
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 Participants
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 Participants
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Weight
|
104.3 kg
Standard Deviation 20.3
|
108.0 kg
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: through 48 weeksEstimates of intervention costs, utilities, direct and indirect costs using market lab cost estimates
Outcome measures
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 Participants
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 Participants
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Estimated Costs of Intervention Strategies
|
1513.42 U.S. dollars
Interval 1451.34 to 1575.49
|
1264.49 U.S. dollars
Interval 1204.39 to 1324.59
|
Adverse Events
Weight Management/Shared Medical Appointment (WM/SMA)
Serious events: 27 serious events
Other events: 12 other events
Deaths: 2 deaths
Shared Medical Appointments (SMA)
Serious events: 27 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 participants at risk
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 participants at risk
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
chest pain/URI
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Vascular disorders
carotid endarterectomy
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Cardiac disorders
percutaneous coronary intervention
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Endocrine disorders
hypoglycemia
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Hepatobiliary disorders
pancreatitis
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
1.5%
2/136 • Number of events 2 • 48 weeks
|
|
Gastrointestinal disorders
rectal bleeding
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Gastrointestinal disorders
constipation
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Gastrointestinal disorders
bowel obstruction
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Gastrointestinal disorders
chest pain/GERD
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Gastrointestinal disorders
hemetemesis
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Infections and infestations
bedbug infestation
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Infections and infestations
sepsis
|
1.6%
2/127 • Number of events 2 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Injury, poisoning and procedural complications
angioedema
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
hand injury
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
1.6%
2/127 • Number of events 2 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Cardiac disorders
pacemaker replacement
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Surgical and medical procedures
gallbladder surgery
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Surgical and medical procedures
joint replacement
|
1.6%
2/127 • Number of events 2 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Surgical and medical procedures
urologic surgery
|
1.6%
2/127 • Number of events 2 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Hepatobiliary disorders
death/cirrhosis
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Vascular disorders
hypotension
|
1.6%
2/127 • Number of events 2 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Vascular disorders
severe hypertension
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Vascular disorders
stroke
|
1.6%
2/127 • Number of events 2 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Gastrointestinal disorders
death/esophageal tear
|
0.79%
1/127 • Number of events 1 • 48 weeks
|
0.00%
0/136 • 48 weeks
|
|
Cardiac disorders
coronary catheterization
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/127 • 48 weeks
|
1.5%
2/136 • Number of events 2 • 48 weeks
|
|
Cardiac disorders
heart attack
|
0.00%
0/127 • 48 weeks
|
1.5%
2/136 • Number of events 2 • 48 weeks
|
|
Cardiac disorders
congestive heart failure
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
angina
|
0.00%
0/127 • 48 weeks
|
1.5%
2/136 • Number of events 2 • 48 weeks
|
|
Cardiac disorders
pacemaker firing
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
death/heart attack
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Infections and infestations
pneumonia
|
0.00%
0/127 • 48 weeks
|
1.5%
2/136 • Number of events 2 • 48 weeks
|
|
Endocrine disorders
hyperglycemia
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Infections and infestations
bacterial peritonitis
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Infections and infestations
flu-like illness
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
coccyx injury
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
arm fracture
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic cancer
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
urinary obstruction
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Infections and infestations
fournier's gangrene
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Surgical and medical procedures
prostate cancer
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Surgical and medical procedures
lumbar fusion
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
|
Vascular disorders
death/stroke
|
0.00%
0/127 • 48 weeks
|
0.74%
1/136 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
Weight Management/Shared Medical Appointment (WM/SMA)
n=127 participants at risk
Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.
Weight management: Weight management group visits using low-carbohydrate diet followed for weight management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
Shared Medical Appointments (SMA)
n=136 participants at risk
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.
Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
|
|---|---|---|
|
Endocrine disorders
hypomagnesemia
|
9.4%
12/127 • Number of events 15 • 48 weeks
|
6.6%
9/136 • Number of events 11 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place